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An Online Continuing Education Activity Sponsored By Grant funds provided by Localized temperature therapy

Localized temp erature therapy

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Page 1: Localized temp erature therapy

An Online Continuing Education ActivitySponsored By

Grant funds provided by

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Continuing Education Program

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Welcome to

LOCALizEd TEmpErATurE ThErApy(An Online Continuing Education Activity)

CONTiNuiNG EduCATiON iNSTruCTiONSThis educational activity is being offered online and may be completed at any time.

Steps for Successful Course CompletionTo earn continuing education credit, the participant must complete the following steps:

1. Read the overview and objectives to ensure consistency with your own learning needs and objectives. At the end of the activity, you will be assessed on the attainment of each objective.

2. Review the content of the activity, paying particular attention to those areas that reflect the objectives.

3. Complete the Test Questions. Missed questions will offer the opportunity to re-read the question and answer choices. You may also revisit relevant content.

4. For additional information on an issue or topic, consult the references.

5. To receive credit for this activity complete the evaluation and registration form.

6. A certificate of completion will be available for you to print at the conclusion.

Pfiedler Enterprises will maintain a record of your continuing education credits and provide verification, if necessary, for 7 years. Requests for certificates must be submitted in writing by the learner.

If you have any questions, please call: 720-748-6144.

CONTACT iNFOrmATiON:

© 2014All rights reserved

Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196

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LOCALizEd TEmpErATurE ThErApy (An Online Continuing Education Activity)

OVErViEW Localized temperature therapy, the application of heat or cold, has long been recognizedas an effective therapeutic intervention. The appropriate application of localizedtemperature therapy has several clinical benefits including pain relief, improved bloodflow and tissue metabolism, removal of wastes and toxins, and reduction in swelling.There are several therapeutic modalities available today that either use the body’snatural thermoregulatory mechanisms to relieve pain, encourage healing, or enhancethe body’s ability to maintain a normal core temperature. Therefore, nurses and otherhealth-care professionals must remain aware of the use of localized temperature therapyas an effective treatment modality. The purpose of this continuing education activity is toprovide a review of the clinical considerations related to localized temperature therapy.An overview of the physiologic process of thermoregulation will be presented, followedby a discussion of the clinical considerations related to the use of localized heat and coldtherapy. Various types of disposable heat and cold therapy products, with a focus onhot and cold packs, will be described. The applicable federal regulations and practiceguidelines for the manufacture and use of disposable hot and cold packs will be reviewed.Finally, selected case studies will provide the participant with the opportunity to synthesizethe information and evaluate workplace scenarios in regard to appropriate use of localizedtemperature therapy.

LEArNEr OBjECTiVESUpon completion of this continuing education activity, the participant should be able to:

1. Describe the physiologic process of thermoregulation.

2. Discuss the clinical implications related to the safe use of localized temperature therapy.

3. Differentiate various types of hot and cold therapy products including their advantages and disadvantages.

4. Identify regulations and guidelines for the manufacture and use of localized temperature therapy products.

5. Critique workplace scenarios regarding the appropriate use of localized temperature therapy.

iNTENdEd AudiENCEThis continuing education activity is intended for nurses, nursing assistants, and other health-care professionals in various practice settings who are interested in learning more about the appropriate use of localized temperature therapy, including its indications, applications, and safety considerations.

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CrEdiT/CrEdiT iNFOrmATiONState Board Approval for NursesPfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP14944, for 2.0 contact hours.

Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes.

The certificate of course completion issued at the conclusion of this course must be retained in the participant’s records for at least four (4) years as proof of attendance.

IACETPfiedler Enterprises has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

CEU Statements• As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs

that qualify under the ANSI/IACET Standard.

• Pfiedler Enterprises is authorized by IACET to offer 0.2 CEus for this program.

rELEASE ANd ExpirATiON dATE:This continuing education activity was planned and provided in accordance with accreditation criteria. This material was originally produced in January 2015 and can no longer be used after January 2017 without being updated; therefore, this continuing education activity expires January 2017.

diSCLAimErPfiedler Enterprises does not endorse or promote any commercial product that may be discussed in this activity.

SuppOrTFunds to support this activity have been provided by Cardinal health.

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AuThOrS/pLANNiNG COmmiTTEE/rEViEWErrose moss, rN, mN, CNOr Casa Grande, CONurse Consultant/Author/Planning CommitteeMoss Enterprises

Judith I. Pfister, RN, BSN, MBA Aurora, COProgram Manager/Planning CommitteePfiedler Enterprises

julia A. Kneedler, rN, mS, Edd Aurora, COProgram Manager/ReviewerPfiedler Enterprises

diSCLOSurE OF rELATiONShipS WiTh COmmErCiAL ENTiTiES FOr ThOSE iN A pOSiTiON TO CONTrOL CONTENT FOr ThiS ACTiViTyPfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest for individuals who control content for an educational activity. Information listed below is provided to the learner, so that a determination can be made if identified external interests or influences pose a potential bias of content, recommendations or conclusions. The intent is full disclosure of those in a position to control content, with a goal of objectivity, balance and scientific rigor in the activity.

Disclosure includes relevant financial relationships with commercial interests related to the subject matter that may be presented in this educational activity. “relevant financial relationships” are those in any amount, occurring within the past 12 months that create a conflict of interest. A “commercial interest” is any entity producing, marketing, reselling, or distributing health care goods or services consumed by, or used on, patients.

Activity Authors/planning Committee/reviewer:

rose moss, rN, mN, CNOr No conflicts of interest

Judith I. Pfister, RN, BSN, MBA Co-owner of company that receives grant funds from commercial entities

julia A. Kneedler, rN, mS, Edd Co-owner of company that receives grant funds from commercial entities

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priVACy ANd CONFidENTiALiTy pOLiCyPfiedler Enterprises is committed to protecting your privacy and following industry best practices and regulations regarding continuing education. The information we collect is never shared for commercial purposes with any other organization. Our privacy and confidentiality policy is covered at our website, www.pfiedlerenterprises.com, and is effective on March 27, 2008.

To directly access more information on our Privacy and Confidentiality Policy, type the following URL address into your browse: http://www.pfiedlerenterprises.com/privacy-policy

In addition to this privacy statement, this Website is compliant with the guidelines for internet-based continuing education programs.

The privacy policy of this website is strictly enforced.

CONTACT iNFOrmATiONIf site users have any questions or suggestions regarding our privacy policy, please contact us at:

Phone: 720-748-6144

Email: [email protected]

Postal Address: 2101 S. Blackhawk Street, Suite 220 Aurora, Colorado 80014

Website URL: http://www.pfiedlerenterprises.com

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iNTrOduCTiONLocalized heat and cold therapy are well-known therapeutic interventions with numerous clinical applications, including relief of localized pain, stiffness, or aching; reduction in inflammation and swelling; decrease in muscle spasm and tightness; and control of bleeding. Heat and cold therapies are based on the same principles, but are on opposite ends of the spectrum, as they produce opposite effects. Heat increases circulation and blood flow, while cold decreases blood flow and slows down the body’s metabolism as well as its oxygen demand.

Today, localized temperature therapy continues to play a role in safe, cost-effective patient care. Therefore, it is necessary for health-care professionals to have an understanding of the mechanisms of action and efficacy of therapeutic heat and cold, as well as the various products available today, in order to recognize which patients would benefit from which modality. Equally important is understanding who might be prone to adverse effects and how to promote safe usage practices.

Normal Thermoregulation 1,2,3,

In order to understand and use localized heat and cold therapy most effectively, it is first necessary to review the process of normal thermoregulation in the human body.

The human body consists of a peripheral shell and a central core. The heat content of the human body is reflected by its temperature. The mean core temperature is 37° C (98.6° F) in healthy adults at rest, but small children have larger daily variations. The core temperature is rather constant in the deeper parts of the body; however, the core temperature may vary several degrees Celsius between different regions of the body, depending on the cellular activity. Warm-blooded animals (e.g., homeotherms such as humans), have a temperature control system and thereby maintain a rather constant core temperature. Their metabolism can change in order to keep heat production equal to heat loss.

Thermoregulation, like many physiological control systems, is dependent upon various levels of positive and negative feedback in order to minimize variations from the normal status. Temperature is regulated by signals derived from nearly every type of tissue, including the hypothalamus, spinal cord, deep core tissues, and the surface of the skin. The processing of thermoregulatory information occurs in three phases: afferent thermal sensing, central regulation, and efferent response, as described below:

• Afferent thermal sensing. Afferent nerve impulses from anatomically distinct cold and warmth skin receptors pass to the central nervous system through the peripheral and sympathetic nerves and return by the efferent pathway to other parts of the body. Although the skin contains both cold and warmth receptors, there are 10 times as many cold receptors as warmth receptors.

• Central regulation. The body’s central control mechanism (i.e., its thermostat) is located in the hypothalamus, which has three functions in temperature regulation:

◦ Integration of thermal signals from both peripheral and core structures;

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◦ Comparison of mean body temperature with the predetermined threshold, i.e., the narrow temperature range across which there is no efferent response; and

◦ Coordination of the appropriate efferent response. How the body determines absolute threshold temperatures is unknown, but the

thresholds vary daily in both sexes by approximately 1° C with the circadian rhythm and monthly in women by approximately 0.5° C. Exercise, food intake, infection, hypothyroidism and hyperthyroidism, drugs (including alcohol, sedatives, and nicotine), as well as cold and warm adaptation alter threshold temperatures. Central temperature regulation is intact from infancy, but may be impaired in premies or in the elderly or extremely ill patients.

• Efferent response. Efferent responses to heat and cold include cutaneous vasodilation or vasoconstriction, piloerection, sweating, and shivering.

If the arterial blood flowing through the thermoregulatory center in the hypothalamus is above the temperature threshold, the hypothalamus initiates impulses that cause heat loss through vasodilation and sweating. Vasodilation of the cutaneous vessels allows greater volumes of blood to reach the skin surface and thereby dissipates excess heat. Sweating cools the body through evaporative cooling. Sweating is the only mechanism by which humans can lose heat in an environment in which the ambient temperature exceeds core body temperature.

A blood temperature that is below the temperature threshold causes the hypothalamus to relay impulses that result in vasoconstriction, thereby decreasing blood flow to the periphery and consequently reducing heat loss. In the pilomotor response, the hairs become more erect to create a layer of still air that reduces convective heat loss.

Shivering generates heat through an increase in the chemical reactions required for muscle activity. Vigorous shivering approximately doubles metabolic heat production; however, this level of intensity cannot be maintained for very long. The overall efficiency of shivering thermogenesis is somewhat lower than expected because muscle metabolism increases blood flow to the peripheral tissues and consequently, heat is lost to the environment.

Nonshivering thermogenesis increases metabolic heat production without producing mechanical work via brown adipose tissue oxidation. Nonshivering thermogenesis increases heat production approximately 100% in infants, but only slightly in adults because the amount of brown adipose tissue in adults is small.

The skin, the largest organ of the human body, is the primary heat exchanger, and maintains the normal body temperature of 37 °C (98.6° F); however, the normal temperature of skin is approximately 33 °C (91 °F). The skin temperature is determined by both the core body temperature as well as the environment (e.g., ambient temperature, humidity, and air velocity). Thus, the skin temperature is essentially determined by the needs of the body to exchange heat energy.

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Localized Temperature TherapyHeat and cold therapies are the two most common types of passive, non-invasive, and non-addictive treatment modalities still widely used in health care today. The application of heat and cold is usually a nursing responsibility. While localized temperature therapy can be quite effective when used properly, it can cause discomfort and even injury when the principles for their use are not followed properly. The clinician must be knowledgeable of the physiologic principles for the effective use of heat and cold in order to implement the therapy safely and maximize its benefits. In addition, the health care worker must be able to teach and supervise other staff members, patients and their families in the use of therapeutic heat and cold modalities. This section will provide a review of the clinical considerations and applications of these modalities, with a focus on localized, disposable heat and cold therapy packs.

heat Therapy4,5,6,7,8,9,10,11

OverviewHeat treatments are defined as therapeutic applications of superficial or deep-heating agents to areas of the body. As noted above, some conditions benefit from the application of heat. Heat causes vasodilation of the blood vessels, which increases blood flow to the area of application. This in turn, increases the amount of oxygen, nutrients, and white blood cells delivered to the body tissues. In addition, vasodilation assists in the removal of waste products from injured tissues, such as debris from phagocytosis.

There are two types of heat treatments: superficial and deep. Superficial heat treatments are applied to the skin over the involved area. The depth of heat depends on types of tissue and ranges from 0.19 in (0.5 cm) to 0.39–0.78 in (1–2 cm). Heat depth also depends on the amount of fat in the area, as fat is an insulator. Several factors determine the extent of the physiologic response to heat, including the following:

• Level of the tissue temperature (usually 40-45º C [104 - 113º F]);

• Duration of the tissue temperature increase;

• Rate of increase in the tissue temperature; and

• Size of the area being treated.

In contrast to deep heating modalities, localized heating modalities usually do not heat deep tissues, including muscles, because the subcutaneous layer of fat beneath the skin surface acts as a thermal insulator as noted above, and therefore inhibits the transfer of heat. In addition, increased cutaneous blood flow from superficial heating causes a cooling reaction as it removes the heat that is applied externally. In general, the transfer of heat, regardless of whether it is used for heating or cooling purposes, is often classified into the following four types of heat transfer:

• Conduction–Conductive heating is defined as heat transfer from one point to another without noticeable movement in the conducting medium. Typically, direct contact takes place between the heat source and the target tissues. Superficial heat is usually conductive heat (e.g., hot water baths, hot packs, electric heating pads, warm compresses).

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• Convection–Convective heating is the form of heating that is created by the movement of the transferring heating medium, usually air or a fluid. Methods for providing convective superficial heat include a whirlpool, moist air baths, and hot air baths.

• Conversion–Conversion heating involves the conversion of one energy form (e.g., light or sound) into another form of energy (e.g., heat). Superficial heat is produced by heat lamps or radiant lights, with heat being transferred when the conveying medium (i.e., the light energy) is converted to heat energy at the skin surface.

• Radiant–Radiant heat loss is the loss of heat to the environment due to the temperature gradient. Heat radiates away from the body if the skin temperature is greater than the temperature of the surrounding environment.

IndicationsThe application of heat is used therapeutically to:

• Relieve localized pain, stiffness, or aching, especially of joints and muscles;

• Decrease muscle spasm and tightness;

• Increase muscle flexibility;

• Increase blood flow to the area, thus aiding wound healing;

• Promote wound drainage;

• Reduce inflammation;

• Increase the body’s temperature; and

• Increase comfort for the patient who states that he/she is chilled.

Contraindications and Adverse Effects from MisuseTherapeutic heat treatments are contraindicated in patients who have bleeding or recent hemorrhage, an acute inflammatory process, or localized infection near the point of application. In cases of infection, heat may cause the area to rupture, resulting in systemic spread of the infection, which may be life-threatening. The application of heat over a large area of the body can cause hypotension and therefore should be used with caution in patients taking certain cardiac and antihypertensive medications. In addition, heat treatments should not be used over areas of malignancy, decreased sensation, or vascular disease. Also, localized heat therapy should be used with caution on patients with heart, lung, or kidney diseases. Deep heat treatments should not be used on areas above the eye, heart, or on a pregnant patient. Deep heat treatments over areas with metal surgical implants should be avoided in case of rapid temperature increase of the metal and the potential for injury.

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Because heat must be fairly intense in order to produce the desired therapeutic effect, burns may result if the heat is applied improperly or for too long. The temperature must be hot enough to achieve its purpose, but maintained within a safe temperature range.

All heat treatments have the potential of tissue damage resulting from excessive temperatures. Proper insulation and treatment duration should be carefully administered for each heating modality. Overexposure during a superficial heat treatment may result in redness, blisters, burns, or reduced blood circulation. Additionally, heat therapy may produce hot spots and therefore is contraindicated for patients with metal implants.

Heat therapy should be used with caution in patients with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis because it may cause disease progression, burns, skin ulceration, and increased inflammation. When using heat therapy, the skin should be protected in heat-sensitive or high-risk patients, especially over regions with sensory deficits. Caution should be used with products that generate high intensity heat (greater than 45ºC), such as with hot packs or electric heating pads; the application time should be restricted for modalities that heat to high intensity levels.

Considerations for Safe UseHeat produces pain and tissue damage at tissue temperatures of 113° F (45° C); therefore, heat therapy with a temperature of greater than 110° F (43° C) should not be used to warm patients due to the risk of burning the skin. In order to be both safe and effective, heat therapy should consistently deliver the highest safe temperature possible without exceeding the tolerance level of the patient’s skin.

Nurses and other health-care professionals must realize that there are metabolic, vascular, and connective tissue effects secondary to therapeutic heat treatments. When heat is required for deep structures such as deep into a joint, deep heat is appropriate. Superficial heating methods are variable and depend on both the area and goal of the heat treatment.

Nurses and other health-care professionals may also need to provide patients with instructions on home therapeutic treatments, as there are many heating agents available commercially. Patients and their families need to be educated on the specific precautions, heating times per day, duration of heating, proper positioning, and any specific instructions related to their physical condition/pathology.

Additional clinical considerations regarding the safe use of heat therapy include:

• Heat is applied only when specifically ordered by the primary health-care provider and done so with caution. The nerves in the skin may become sensitized and numbed, so the patient may not feel the pain of a burn, especially if heat has been applied frequently.

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• Specific body parts, such as the eyelids, neck, and inside of the arms, are particularly sensitive to heat.

• Each patient has his/her own individual sensitivity to heat; therefore, the nurse should assess the patient for his/her heat sensitivity. In addition, the heat should be applied slowly and the patient’s reaction assessed. This will help the nurse determine how much heat the patient can tolerate and for how long.

• Infants, elderly patients, and those with thin, fair skin have a lowered resistance to heat.

• Patients who are unresponsive, anesthetized, and those with neurological and psychological disorders or dementia are also at higher risk for injury due to the application of heat, as these patients are often unable to report when the heat is too intense.

• Impaired circulation and some metabolic diseases (e.g., peripheral vascular disease, or diabetes) increase the patient’s susceptibility to burns.

• Patients undergoing chemotherapy or radiation therapy for cancer, as well as those with any degree of paralysis, are particularly susceptible to burns.

• Always read and follow the manufacturer’s written instructions for the safe use of all heat therapy treatment modalities.

It is important to note that patient complaints should be taken seriously. Every patient’s tolerance is different and only he/she can report how the therapy feels. If the patient complains of pain or discomfort, the therapy should be stopped immediately and the primary health-care provider consulted.

Localized Heat Therapy ProductsLocalized heat therapy is available in many forms today, including hot water bottles, warm moist compresses, electric heating pads, heat lamps, paraffin baths, hydrotherapy, and commercially manufactured chemical/gel hot packs. Each of these is described in detail below.

• A hot water bottle is a form of superficial heat treatment. The bottle is typically filled half way with hot water, covered with a protective toweling, and then placed on the treatment area where it remains until the water has cooled.

• Warm, moist compresses are also used to apply heat to either a small or large area.

• Electrical heating pads continue to be used primarily as a home treatment, as safety and convenience issues have limited their use in health-care settings.

• Heat lamps provide heat therapy via an infrared heat lamp. Care must be taken to avoid burns; they should not be used in patients with a severe heart, liver, or kidney disorder, peripheral vascular disease, or reduced skin sensation.

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• A paraffin bath involves dipping, immersion, or painting of the affected body part with melted wax. It is used primarily for small joints, such as those of the hand, knee, or elbow; it should not be used for open wounds.

• Hydrotherapy involves immersion in agitated warm water in a large industrial whirlpool. Hydrotherapy enhances wound healing by stimulating blood flow and facilitating debridement of burns and wounds; it also is used to relax muscles and relieve pain.

• More recently, several manufacturers have developed disposable, single-use chemical hot packs for use in the health-care setting. Instant hot packs work in one of two ways. Hot packs that utilize supersaturated aqueous sodium thiosulfate within an inner pouch are activated by squeezing the pack to rupture the inner pouch. When the inner pouch is ruptured, the solution is exposed to particles within the pack, causing the sodium thiosulfate solution to crystallize rapidly and release heat for 20-30 minutes. Figure 1 depicts the sodium thiosulfate type of localized heat product.

Figure 1. Sodium Thiosulfate hot pack.

Hot packs that utilize magnesium sulfate contain an inner pouch of water and granules of the chemical loose within the pack. When the water pouch is ruptured, the granules begin to dissolve, releasing heat. The rate at which heat is released is less controlled with this method, as the chemical dissolves at different rates depending on a variety of factors. Punctured commercial hot packs should be discarded immediately and the skin washed, as the chemical agent can burn the skin. Table 1 and 2 compare the efficacy and costs of the two types of packs.

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Table 1 – Comparison of Sodium Thiosulfate and Magnesium Sulfate Hot Packs

Chemical Name Chemical Costhot pack

manufacturing process

Temperature pattern

Sodium Thiosulfate More expensive More difficult Consistent temperature near 110° F (43°C)

Magnesium Sulfate Less expensive Less difficult Starts very hot; temperature decreases rapidly

Table 2 – Sample Cost Comparison of a Single Heat Therapy Treatment Utilizing Sodium Thiosulfate and magnesium Sulfate hot packs

Cost Analysis Sodium Thiosulfate magnesium Sulfateprice per hot pack $ 1.00 $ 0.70Packs per Treatment 1 2Subtotal $ 1.00 $ 1.40Disposable Cover N/A $ 0.85Total $ 1.00 $ 2.25

Specialty Applications: Neonatal Heat TherapyIn addition to the general indications noted above for disposable heat packs, there are also specialty applications for various aspects of neonatal warming. For example, disposable infant heel warmers can be used to help increase the infant’s blood flow to facilitate a quality heel stick without repeated attempts. Warming the area also reduces hemolysis and bruising; moreover, hematocrit and capillary blood gas samples collected from unwarmed heels are less accurate.4 Figure 2 illustrates the infant heel warmers.

Figure 2. infant heel Warmer.

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In some clinical practice settings, infant heel warming is often accomplished without the use of infant heel warmers by methods such as a glove filled with warm water, wrapping the site with a towel or diaper that has been moistened with warm water, using fluids or other products warmed in a microwave oven, or even using one’s hands against the heel. All of these methods are ineffective and may be problematic in that they provide an inexact temperature, which may not be warm enough in some instances or may be too hot and present a burn risk; or they may be a source of cross-contamination. As will be discussed below, commercially prepared heel warmers are regulated as Class 1 medical devices by the United States Food and Drug Administration (FDA) with strict temperature controls, thereby offering a more reliable method of temperature-regulated heel warming.

In addition to infant heel warmers, specialized disposable neonatal warming mattresses provide an effective method to prevent hypothermia and are used for transportation of neonatal patients within a facility or between facilities, as they eliminate the need for electricity or wires and helps absorb vibration during transport. Some mattresses are also available without metal components, making them safe for use during radiologic procedures, including magnetic resonance imaging (MRI). Figure 3 shows an example of an infant warming mattress.

Figure 3. infant Warming mattress.

Cold Therapy4, 12, 13, 10

OverviewCold therapy produces vasoconstriction, which reduces circulation to the affected area, thereby slowing the body’s metabolism as well as its demand for oxygen. The application of cold prevents the escape of heat from the body, which also relieves congestion and often relieves muscle spasm. In general, the therapeutic goals of cold therapy include controlling hemorrhage, preventing edema, reducing inflammation, and blocking pain receptors.

Cold therapy is more effective than heat for soft tissue injuries and sprains and is the preferred treatment within the first 48 hours after the injury. Cold therapy is applied to prevent additional swelling; however, it will not reduce the edema that is already present. Cold therapy should be applied as ordered, usually for 15-20 minutes.

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During cold therapy, a drop in skin temperature is almost immediate, followed quickly by a fall in subcutaneous temperature. Deeper structures are much less efficiently cooled. The patient initially perceives a sensation of cold, then an ache or burning, and finally cutaneous anesthesia. The analgesic effects are mediated by cold’s effect on nerves and nerve endings, by its counterirritant effects and by reduction of metabolic activity. All nerve fiber types are affected by cold. For example, small myelinated (pain) fibers are affected first, then large myelinated fibers, then unmyelinated fibers. Nerve conduction velocity decreases proportionately to decreasing temperature; cold also increases the time of the nerve’s recovery cycle after excitation and increases the refractory period.

Cooling below 68°F (20°C ) reduces acetylcholine production, which helps relieve muscle spasms and promotes comfort.

In patients who have less than 1 cm of subcutaneous fat, the temperature at 1 cm muscle depth drops 3.6-5.4° F (2-3° C ) with 10 minutes of cold application via an ice bag. However, patients who have more than 2 cm of fat experience little change in muscle temperature, even at a muscle depth of 1 cm. The greatest reductions in temperature are achieved with ice water immersion. Rewarming takes a long time due to vasoconstriction; return to baseline temperature can take over one hour.

Severe reactions to cold are rare; they are related to hypersensitivity reactions and include the release of histamine (i.e., cold urticaria), generalized symptoms from cold hemolysis and agglutinins, and a generalized reaction from cryoglobulins.

IndicationsThe application of cold is used therapeutically to:

• Reduce or stop bleeding;

• Slow bacterial activity in patients with infections;

• Relieve postoperative pain following some types of surgical procedures, tooth extractions, headaches, or muscle or joint injury;

• Prevent swelling in injured tissues, including fractures and sprains;

• Prevent peristalsis in patients with abdominal inflammation;

• Relieve pain in engorged breasts;

• Control pain and fluid loss in the initial treatment of burns; and

• Diminish muscle contraction and spasm.

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ContraindicationsCold is contraindicated for patients who have developed hypertension during cold treatment, due to secondary vasoconstriction, or have a cold allergy (e.g., hives, joint pain) or cryoglobulinemia, or any disease that produces a marked cold pressure response. Cold should not be applied to areas of reduced skin sensitivity or to tissues with vascular impairment. Therefore, it is contraindicated in patients who have Raynaud’s syndrome, rheumatoid arthritis, local limb ischemia, arteriosclerosis, peripheral vascular disease, or sickle cell anemia, as cold can further impair local blood flow.

Adverse Effects from MisuseProlonged exposure to temperatures below freezing will lead to freezing of tissue. Cold should not be used at temperatures less than 37.4 - 39.2° F (3 - 4° C). Pain from cooling is generally felt at tissue temperatures at or below 64.4° F (18° C). Some newer brands of cold packs are designed for direct tissue applications; however, with older brands, the ice pack should not be applied directly to the skin. Be sure to consult with the manufacturer’s instructions. Unless direct application is indicated by the instructions for use for the cold agent, a barrier, such as a towel, should be placed between the cold agent and the skin’s surface to prevent skin and nerve damage.

As noted, cold therapy can block pain receptors, which is often used to facilitate activity in an injured limb. However, caution should be exercised with these patients, since the analgesic effect may allow the patient to exceed his/her desired activity level, and cause undesirable tissue damage.

Nursing Considerations for Safe UseAdditional clinical considerations regarding the safe use of cold therapy include:

• Patient complaints of numbness in the area of the cold therapy application, along with the skin appearing blanched or spotty, indicate the need to discontinue the therapy. The primary health-care provider should be consulted.

• Continued application of cold affects deeper tissues; therefore it is vital that the patient is monitored closely.

• Cold packs with crystals can become very cold and as a result, can cause the tissue to freeze very quickly. Therefore, caution should be used when applying these products.

• Read and follow the manufacturer’s written instructions for the safe use of all cold therapy treatment modalities.

• Punctured commercial cold packs should be discarded immediately, as the chemical agent/gel will burn the skin of either the patient or the health-care professional. In addition any skin that has come in contact with the punctured cold packs should be washed.

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Localized Cold Therapy ProductsLocalized cold therapy is available in many forms, including vapocoolant sprays, refrigerant inflatable bladders, thermal cooling blankets, and disposable ice bags and cold packs.

• Vapocoolant sprays can drop skin temperatures sharply, e.g., to 45° F (7.2° C) and should be applied intermittently for 15 to 30 minutes. The temperatures in muscle 1¼ inches deep and intraarticular knee temperatures can drop approximately 9° F (5° C). Vapocoolant sprays have generated some concern because they contain chlorofluorocarbons that can harm the ozone layer.

• Refrigerant inflatable bladders combine cold and compression, which is often more effective than cryotherapy alone; however, the cryotherapy value of the bladders is considered minimal.

• Thermal cooling blankets have improved postoperative treatment for some patients. Patients receiving treatment with cooling blankets have had better outcomes regarding effusion, ambulation, use of narcotics, range of motion, quadriceps function, and pain.

• Ice, applied in ice bags, is an effective and inexpensive method of cold therapy. Disposable ice bags are available in a variety of specialized sizes, shapes, and design for areas that have been hard to cover with traditional ice bags, such as the limbs, abdomen, eyes, face, and perineum. Many are available with various options to keep bags in place, including ties and elastic straps and with an outer covering to protect the skin and avoid nerve injury and frostbite. Figure 4 shows a variety of ice bags used for cold therapy.

Figure 4. ice Bags.

• Disposable, single-use endothermic reaction chemical cold packs are also available for use in the health-care setting today. Cold packs are available commercially in many sizes and shapes, often with laminated materials for added strength and insulation.

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The chemical ammonium nitrate is most often used in cold packs because it dissolves in water endothermically, i.e., it absorbs heat when dissolved. In the disposable packs, deionized water and ammonium nitrate are kept in separate compartments until the pack is needed. As with a disposable hot pack, the cold pack is also activated by breaking the seal on the pouch containing the water and then shaking it vigorously; by this action, the ammonium nitrate dissolves in the water, thereby absorbing heat and starting the endothermic reaction. The freezing agent stabilizes at approximately 33° F (0.56° C); the pack stays cold longer than ice with an approximate duration of 30 minutes. Other chemicals besides ammonium nitrate that can be used in the manufacture of cold packs include calcium chloride, sodium chloride, and ammonium chloride. However, ammonium nitrate is the most commonly used chemical in cold packs because it is highly water soluble and the solution becomes very cold more quickly.

Specialty Applications: Postpartum Care4

One specialty application of cold packs is maternal postpartum care, during the early postpartum period. Applying ice or a cold pack to the perineum during the first 24 hours after birth helps prevent perineal edema and the possibility of hematoma formation, thereby reducing pain and promoting healing and patient comfort. However, the application of cold after the first 24 hours is no longer therapeutic; after this time, healing is facilitated if circulation to the area is increased with the use of heat.

Commercial cold packs combined with absorbent perineal pads are now available. Perineal cold packs typically activate instantly and provide a safe and controlled temperature for approximately 30 minutes. Available as an all-in-one design, the packs are cost effective, as they help to reduce nursing time and also eliminate the need for additional supplies and linens. Premium perineal pads are anatomically shaped, have an adhesive tape to secure the pad to garments that hold the pack securely against the perineum, and have a plastic backing to prevent strike-through and subsequent contamination of linens. Utilizing individually wrapped commercial cold packs instead of home remedy ice methods allows for a lesser degree of cross-contamination, which is important, given that the perineum may be compromised from episiotomy or tearing while giving birth. Avoid self designed ice packs.

Similarities and differences of hot and Cold Therapy15

As previously described, modalities for the application of heat and cold can be used effectively for a variety of clinical conditions. Because many patients can benefit from the use of both of these modalities, it is helpful to review their similarities and differences. Their similarities include that they both decrease muscle spasm secondary to musculoskeletal pathology or nerve root irritation. They also cause analgesia. The significant differences between the physiologic effects of heat and cold therapy are as follows:

• Cooled muscle requires a longer time to return to normal temperature. Because the application of heat increases blood flow, a heated muscle returns to normal temperature after a few minutes.

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• The application of heat for the relief of muscle spasm is secondary to muscle hyperemia, which reduces muscle spasm–induced ischemia/pain and interrupts this vicious cycle.

• Increased tissue metabolism occurs with an elevation in temperature; conversely, metabolism is decreased by cold therapy modalities.

• Blood flow increases with heat and decreases with cold.

• The tendency to bleed increases with heat and decreases with cold.

• The formation of edema is facilitated by heat and is decreased by cooling.

• Immediate cooling of burns is beneficial; however, frostbite is treated by rapid warming.

• Joint stiffness decreases with heating; increases with cooling.

• Due to blood pooling, orthostatic hypotension is produced by the application of heat to large parts of the body. With the application of cold therapy, hypotension is decreased secondary to vasoconstriction. Figure 5 illustrates the types of hot and cold packs.

Figure 5. Instant hot, cold and reusable gel packs.

In order to provide safe, therapeutic care to the patient receiving localized heat and cold therapy, it is important to adhere to certain basic physiological principles as outlined in Table 3.

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Table 3 – Principles for Safe and Effective Application of Heat and Cold Therapy16

physiological principles implications1. Nerve receptors for heat and cold adapt readily if the stimulus is not extreme.

1. Once receptors adapt, the patient may be unaware of temperature extremes until tissue damage occurs. Explain to patient and caution not to increase the heat or cold.

2. Tolerance of temperature varies with the individual. Certain areas of the body are more tolerant to temperature than others.

2. Apply heat and cold well within safety range of temperature. Observe skin for sensitivity regardless of temperature used.

3. Water conducts heat better than air. 3. Moist heat such as a warm, wet dressing must be applied at a lower temperature than dry heat.

4. The condition of the patient can alter his tolerance to heat and cold.

4. The very old and very young do not tolerate heat well. Special care is required for debilitated or unconscious patients. Patients with disturbances in circulation are more sensitive to heat and cold. It may be contraindicated or temperatures must be less extreme than normally used.

5. Cold immediately constricts blood vessels.Prolonged use causes dilation of vessels. Heat immediately dilates blood vessels, but vessels constrict with prolonged application.

5. Various applications differ in recommended length of application. However, 15 to 30 minutes is the usual length of time for application, but may be up to one hour, followed by at least one hour before reapplying.

6. The skin is the body’s first line of defense against infection.

6. Heat or cold applied to open wounds or lesions that may rupture demands the use of sterile technique.

Special Considerations for Pediatric Patients17,11

It is important to remember that children are not simply “small adults”. For this reason, there are special considerations for both heat and cold therapy. The local application of either heat or cold therapy should never be applied to pediatric patients without a specific order. Once the order is written, the nurse is responsible for applying the treatment, closely monitoring the effects of the treatment, and documenting those observations. Documentation parameters for both cold and heat therapy include the type of therapy, start time, duration of therapy, and the condition of the skin before and after the application.

With the use of heat therapy, tissue damage can occur, particularly in fair-skinned children or those who have experienced sensory loss or impaired circulation. Children should be closely monitored and none should receive heat treatments longer than 20 minutes at a time, unless specifically ordered. Moist heat produces quicker results than does dry heat and is usually applied in the form of a warm compress or soak. Dry heat is applied via an electric heating pad, a water-circulating blanket, or an infant-specific

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instant warming mattress. The use of instant hot packs may be advised; but, be sure to check with your individual manufacturer. Hot water bottles are not recommended due to the occurrence of burns associated with improper use. An electric heating pad or water-circulating blanket should be covered with a pillow case, towel, or stockinette. General clinical guidelines for the use of warming measures in pediatric patients include:

• A child’s temperature should be maintained between 97.7° and 99.5° F (36.5-37.5° C).

• A preterm infant’s temperature should maintained between 97.3° and 98.9° F(36.3-36.9° C).

• Hypothermia is considered to be a body temperature below 97.2° F (36.2° C) and may occur in premature infants and in children with intracranial birth injury, shock, critical illness, or those under heavy sedation.

• All preterm infants should be maintained under a radiant warmer or in an isolette until they can maintain their body temperature within a normal range without adjunct therapy.

• Warming measures should be initiated when a child’s axillary temperature is less than or equal to 97.2° F (36.2° C).

• A child’s temperature should be closely monitored while warming measures are in use and until it has returned to within normal parameters.

• Profoundly hypothermic children should be placed on a cardiorespiratory monitor.

• An infant’s head and feet should be covered; the infant’s head represents a large percentage of the body surface area, therefore heat can be lost rapidly if the head remains uncovered.

As with heat, intervals of approximately 20 minutes are recommended for both dry cold (e.g., ice bags and commercial instant-cold preparations) as well as moist cold (e.g., cold compresses, soaks, or baths). Dry cold applications should be lightly covered to protect the child’s skin from direct contact. Because cold decreases circulation, prolonged contact can result in frostbite or gangrene. The child’s skin should be inspected before and after the application of cold therapy in order to detect redness or irritation. With the application of either heat or cold therapy in pediatric patients, facility-specific policies and procedures should always be followed.

Regulations and Guidelines Regarding the Manufacture and Use of Disposable Localized Temperature Therapy Products

It is also important that health-care professionals maintain awareness of the regulations regarding manufacture of disposable localized temperature therapy products, the current economic implications of hospital-acquired burns, and applicable guidelines for their use.

The United States FDA regulates the manufacture of heat and cold therapy products in its Guidance Document for the Preparation of Premarket Notification [510(k)] Applications

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for Heating and Cooling Devices.18 The FDA defines a hot or cold disposable pack as a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces; they are classified as Class I medical devices. Except when intended for use on infants, these devices are exempt from the FDA’s premarket notification procedures.

Safety Concerns and CMS Reimbursement ImplicationsWhile the safety of patients has always been the primary concern for all health-care professionals, it has recently become even more important from a financial standpoint. Effective October 1, 2008, the Centers for Medicare & Medicaid Services (CMS) has classified a burn acquired within a facility as a non-reimbursable secondary diagnosis. CMS routinely identifies hospital-acquired conditions that: 19

• Are high cost or high volume or both;

• Result in the assignment of a case to a diagnosis-related group (DRG) that has a higher payment when it is present as a secondary diagnosis; and

• Could reasonably have been prevented through the application of evidence-based guidelines.

Once a hospital-acquired condition is identified, hospitals no longer receive additional payment for that condition. In other words, if a condition is not present upon admission, but is subsequently acquired during the course of the patient’s hospital stay, Medicare no longer pays the additional costs of the hospitalization; in addition, the patient is not responsible for the additional costs. The changes to these payment provisions provide additional incentives for health-care facilities to improve the quality of care delivered to Medicare patients by focusing efforts on preventing hospital-acquired patient burns.

Recently, the American College of Physicians and the American Pain Society issued a joint clinical practice guideline for the treatment of low back pain.20 In this guideline, the application of superficial heat was found to have good clinical evidence and was determined to have a moderate net benefit; therefore, the panel recommended that clinicians consider offering the therapy to eligible patients. Specifically, the panel found that the intervention improves health outcomes and concludes that benefits moderately outweigh harms, or that benefits are small but there are no significant harms, costs, or burdens associated with the intervention.

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SummAryLocalized applications of heat and cold are well-known therapeutic interventions that are indicated for a variety of clinical conditions, including patients suffering sports-related injuries and arthritic conditions. Because localized temperature therapy continues to play a role in safe, cost-effective patient care, it is essential that health-care professionals have an understanding of the human thermoregulatory process, as well as the principles of heat and cold therapy in order to maximize their benefits. There are several modalities available to achieve localized temperature therapy. Today, disposable hot and cold packs are convenient, as well as cost-effective, and can be used for a variety of therapeutic applications in numerous practice settings. A thorough understanding of the principles of heat and cold therapy, the associated clinical considerations for safe use, and the products available today will enable health-care professionals to provide safe, quality patient care and ultimately promote positive patient outcomes.

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CASE STudiES The following case studies are presented to allow the learner to synthesize and apply the concepts discussed to workplace scenarios. Read the scenarios carefully, integrating the data and information to discuss the points to consider.

Case Study 1: Too Hot for ComfortDeb Bowers, RN is working the day shift and caring for Mrs. JR on the general medical unit of County General Hospital. Mrs. JR is an 86-year-old female who was admitted from the emergency department (ED) with a urinary tract infection (UTI) and rule out stroke. She is currently receiving intravenous (IV) therapy for the UTI while hospitalized for additional diagnostic tests; she has type II diabetes, hypertension, and moderate aortic valve stenosis. During the night shift, the IV catheter that was placed in Mrs. JR’s left forearm in the ED infiltrated; Deb is preparing to restart the IV in time for the next dose of antibiotics.

In Deb’s initial assessment of Mrs. JR’s arms, she does not see many “good” veins; Mrs. JR stated that the ED nurse had trouble starting the IV and it “hurt a lot.” Since it was two hours before the next scheduled antibiotic administration, before proceeding, Deb obtained two disposable hot packs to apply to Mrs. JR’s forearms. She noticed that the hot packs on the supply cart were slightly different than the ones she had used in the past; but after a quick look at the packaging, Deb decided they were essentially the same as the previous ones. Deb proceeded to activate and apply two warm packs, one to each of Mrs. JR’s forearms and went on to assess her other patients. After approximately one hour, Jonathan Richards, CNA informed Deb that he answered Mrs. JR’s call light at which time she said her arms were hot and starting to hurt.

Upon reassessing Mrs. JR’s forearms, she again states that her arms feel very warm and have been hurting. When Deb removed the packs, she noted a small, fluid-filled blister measuring approximately 1 cm by 2 cm on Mrs. JR’s right anterior forearm and another fluid-filled blister measuring approximately 2 cm x 0.5 cm was noted on her left posterior forearm.

Points to Consider:

1. What are the important clinical considerations in this scenario?

2. What steps should Deb take next?

3. What should Deb have done differently?

Discussion of Points to Consider:

1. What are the important clinical considerations in this scenario?

- Application of heat therapy in an effort to enhance vasodilation and facilitate ease of IV insertion.

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- Mrs. JR’s physical status and medical history: elderly, diabetes; hypertension; aortic valve stenosis – all of these are indicative of impaired circulation, which lower her resistance to heat and also increase her susceptibility to burns.

- Mrs. JR’s complaints: Mrs. JR complained that the hot pack was too hot; all patient complaints should be taken seriously.

2. What steps should Deb take next?

- Clean and cover both sites with a dressing.- Start the IV in another site. - Notify the physician for additional orders or change in the plan of care.

What should Deb have done differently?

- Because every patient has his/her own individual sensitivity to heat, Deb should have assessed Mrs. JR for her heat sensitivity prior to initiating heat therapy.

- The heat should have been applied slowly and Mrs JR’s reaction assessed in order to determine how much heat she could tolerate and for how long.

- Deb should have read and followed the manufacturer’s written instructions for the safe use of this specific hot pack, noting specific instructions for application, e.g., if it could be applied directly to the skin.

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Case Study 2: The Chemical SpillLater that day, Jonathan Richards, CNA is caring for Mr. SB, a 68-year-old male admitted for pneumonia that fell that morning when ambulating to the bathroom, injuring his left knee. Mr. SB is a relatively healthy 68-year-old and has no history of arthritis, arteriosclerosis, or peripheral vascular disease. The physician has ordered a cold therapy pack to reduce the swelling. Jonathan is busy covering patients for Jane Thomas, CNA, while she is at lunch. Since Mr. SB has been complaining that he felt the swelling was getting worse all morning. Jonathan hurriedly grabs the cold pack from the supply cart and squeezes it forcefully to activate it while on his way to Mr. SB’s room. Jonathan immediately felt liquid dripping onto his right hand and observed the clear fluid seeping from a corner of the package. Since there wasn’t a large amount of fluid seeping out, Jonathan hurriedly continues on his way to Mr. SB’s room and places the cold pack on his left knee. After 30 minutes, Jane has just returned from lunch and responds to Mr. SB’s call light. Mr. SB is complaining that his knee feels wet and numb and his skin is burning. Jane examines Mr. SB’s knee and notes that the skin is blanched. She immediately removes the cold pack and washes Mr. SB’s skin and then proceeds to find Deb Bowers, RN to ask her to contact the physician.

Points to Consider:

1. What are the important clinical considerations in this scenario?

2. What should Jonathan have done differently?

3. What should Jane have done differently?

Discussion of Points to Consider:

1. What are the important clinical considerations in this scenario?

- Cold therapy was ordered appropriately to reduce the swelling in Mr. SB’s injured knee; Mr. SB does not have any of the conditions that would contraindicate cold therapy (e.g., vascular impairment).

- Jonathan was in a hurry since he was caring for Jane’s patients, in addition to his own, while she was at lunch and because Mr. SB had been complaining of pain; he noted that the cold pack was punctured, as he felt the liquid dripping on his hand, but decided to use it anyway.

2. What should Jonathan have done differently?

- He should have discarded the punctured cold pack instead of applying it to Mr. SB’s knee, since the chemical agent/gel can burn the skin of either the patient or the health-care professional. He should have also washed the skin.

- He also should have read and followed the manufacturer’s written instructions for the safe use of a cold therapy pack, including those for activation and steps to take in the event of a puncture.

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- Jonathan should also be more cautious when applying cold packs, since they can become very cold and as a result, can cause the tissue to freeze very quickly.

- All staff members should monitor Mr. SB more closely during periods of cold therapy.

3. What should Jane have done differently?

- Nothing–her actions were appropriate–upon hearing Mr. SB’s complaint of wetness and numbness in the area, along with noting that his skin was blanched, she discontinued the cold therapy and asked Deb to consult with the primary health-care provider.

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GLOSSAry OF TErmSAfferent Carrying inward to a central organ or section, as

nerves that conduct impulses from the periphery of the body to the brain or spinal cord.

Brown Adipose Tissue A type of specialized fat known to convert fat calories into heat by nonshivering thermogenesis. Brown adipose tissue is a unique source of heat energy for the infant because it has greater thermogenic activity than ordinary fat; its deposits occur around the kidneys, neck, and upper chest.

Conductive heating Heat transfer from one point to another without noticeable movement in the conducting medium; direct contact takes place between the heat source and the target tissues.

Convective heating The form of heating that is created by the movement of the transferring heating medium, usually air or a fluid.

Conversion heating The form of heating that involves the conversion of one energy form (e.g., light or sound) into another form of energy (e.g., heat).

Core Body Temperature The temperature of the thermal compartment of the body containing highly perfused tissues and major organs.

Cryoglobulin An abnormal blood protein that has the unusual property of precipitating from the blood serum when it is chilled.

Cryotherapy The use of cold temperature as a form of treatment for an injury.

Efferent A nerve conveying impulses from the central nervous system to the periphery.

Endothermic reaction A chemical reaction accompanied by the absorption of heat.

Exothermic reaction A chemical reaction in which heat is given off, i.e., liberated.

homeotherm A warm-blooded animal (e.g., homosapiens) that maintains a relatively constant and warm body temperature independent of environmental temperature; also known as endotherm.

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Nonshivering Thermogenesis Increased heat production due to enhancement of normal calorigenic metabolic processes, i.e., production of heat in response to cold stress by other than muscle contractions (shivering), i.e., by brown adipose tissue.

Neonatal Thermogenesis Heat gain comes from the metabolism of the neonate’s stores of brown fat; because thermogenesis is relatively inefficient in neonates, it is important to protect them from cold stress.

Normothermia A core body temperature of 37° C (98.6° F).

piloerection Erection of hair, due to action of bundles of smooth muscle fibers attached to the deep part of the hair follicles; also known as “goose bumps.”

pilomotor Pertaining to the arrector muscles, the contraction of which produces piloerection.

raynaud’s Syndrome A circulatory disorder caused by insufficient blood supply to the hands and feet, resulting in cyanosis, numbness, pain, and gangrene, in extreme cases.

Shivering Thermogenesis The fastest thermogenic process which the static body can use; shivering is an involuntary function with a tremor rate of about 10 per second.

Thermogenesis The generation or production of heat, especially by physiological processes.

Thermoregulation Maintenance of the body’s core temperature within a tolerable range.

Vapocoolant Spray A topical spray that sharply decreases the temperature of the skin; often used for pain control.

Vasoconstriction Narrowing of the blood vessels resulting from contracting of the muscular wall of the vessels.

Vasodilation Widening of the blood vessel lumen resulting from relaxation of the muscular wall of the vessels.

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rEFErENCES1. Sessler, DI. What’s Hot in Thermoregulation? http://www.csaol.cn/img/2007ASA/

RCL_src/310_Sessler.pdf. Accessed September 25, 2014.

2. Charkoudian N. Skin blood flow in adult human thermoregulation: how it works, when it does not, and why. Mayo Clinic Proceedings. 2003; 78(5):603-612.

3. Elert G. Temperature of a healthy human (skin temperature). http://hypertextbook.com/facts/2001/AbantyFarzana.shtml. Accessed September 25, 2014.

4. Rosdahl, CB and Kowalski, MT Heat and cold applications. Textbook of Basic Nurs-ing, 10th ed. Philadelphia, PA; Wolters Kluwer Health/ Lippincott Williams & Wilkins; 2011.

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15. Heat and cold application, independent study. Foundations for Nursing Practice Skills Laboratory Handbook, Richmond, MCV/VCU School of Nursing; 1980.

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17. U.S. FDA. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMIN-ISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 890 -- PHYSICAL MEDICINE DEVICES Subpart F--Physical Medicine Therapeutic Devices Sec. 890.5710 Hot or cold disposable pack. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=890.5710. Accessed September 25, 2014.

18. CMS. Hospital-acquired conditions. http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalAcqCond/index.html?redirect=/HospitalAcqCond/06_Hos-pital-Acquired_Conditions.asp. Accessed September 25, 2014.

19. Chou R, Qaseem A, Snow V, Casey D, Cross Jr. JT, Shekelle P, and Owens DK for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians and the American College of Physicians/American Pain Society Low Back Pain Guidelines Panel. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Annals of Internal Medicine. 2007; 147(7):478-491.