RAJIVGANDHI UNIVERSITY OF HEALTH SCIENCESBANGALORE, KARNATAKA

PERFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

Mr. ALEX JOHNM.Sc. NURSING 1ST YEARMEDICAL SURGICAL NURSINGYEAR 2010-2012

PADMASREE INSTITUTE OF NURSINGBANGALORE

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCESBANGALORE, KARNATAKA

PERFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.NAME OF THE CANDIDATE AND ADDRESSMr. Alex John1st year M.Sc (Nursing)Padmashree Institute of NursingBangalore.

2.NAME OF THE INSTITUTIONPadmashree Institute of NursingBangalore.

3.COURSE OF THE STUDY AND SUBJECT1st year M.Sc (Nursing)Medical Surgical Nursing.

4.DATE OF ADMISSION TO THE COURSE2nd July 2010

5.TITLE OF THE STUDYThe effectiveness of application of combination of Magnesium Sulphate and Glycerine dressing on management of limb oedema among patients with Thrombophlebitis.

6. BRIEF RESUME OF THE INTENDED WORK

6.1 INTRODUCTION: Circulatory system is major system in human body; veins are blood vessels that carry blood towards the heart. Millions of veins are present in human body, the length of veins are 60,000 100,000cm. Most of the veins carry deoxygenated blood from the tissues back to the heart; exceptions are the pulmonary and umbilical veins, both of which carry oxygenated blood to the heart. Vein colour is determined in large part by the colour of venous blood, which is usually dark red as a result of its low oxygen content. Veins are classified in a number of ways, including Superficial versus Deep, Pulmonary versus Systemic, and Large versus Small. 1The common disease conditions affecting veins are Thrombophlebitis, Deep vein thrombosis, varicose vein, venous stasis ulceration and chronic venous insufficiency. Phlebology is the medical discipline that involves the diagnosis and treatment of disorders of venous origin. The American Medical Association has added Phlebology to their list of self-designated practice specialties. A medical specialist in Phlebology is termed a phlebologist. Phlebitis means inflammation of a vein. Thrombophlebitis is the term used when a blood clot in the vein causes the inflammation. Thrombophlebitis usually occurs in leg veins, but it may occur in arms. The thrombus in the vein causes pain and irritation and may block the blood flow in the veins. Blood clots (thrombi) can form which may break off and travel to the lungs. This is a potentially life threatening condition called Pulmonary embolism.2The Thrombophlebitis is caused by an injury to a vein (mainly due to vein puncture). Blood clot may occur due to sitting for hours at a time, confined to bed for prolonged time, use birth control pills, pregnancy or immediately after birth, varicose vein and obese.

Superficial Thrombophlebitis is usually an easily diagnosed condition; it may be an iatrogenic, resulting from intravenous catheter or infusion of solutions. Deep vein thrombosis (DVT) is Thrombophlebitis of deep veins. It is a common disorder, more so in women than in men. Deep vein thrombosis develops in approximately one third of clients older 40 years who have had major surgery, orthopaedic surgery, or myocardial infarction. In addition clients with cancer or family history of clotting disorders are at risk. Phlebitis, if mild, may or may not cause symptoms. Pain, tenderness, redness (Erythema), and bulging of the vein are common symptoms of phlebitis. The redness and tenderness may follow the course of the vein under the skin. Low grade fever may accompany superficial and deep phlebitis. High fever or drainage of pus from the site of Thrombophlebitis may suggest an infection of the Thrombophlebitis (referred to as septic Thrombophlebitis). Palpable cords along the course of the vein may be a sign of a superficial clot or superficial Thrombophlebitis. A deep venous thrombosis may present as redness and swelling of the involved limb with pain and tenderness. In the leg, this can cause difficulty in walking.The treatment of Thrombophlebitis consist of self-care steps that include applying heat to the painful area, elevating the affected leg and using an over-the-counter non steroidal anti-inflammatory drug (NSAID), medications like anticoagulant, support stockings and bypass surgeries. Some recent trends in hospital care include the application of magnesium sulphate (Epsom salt) for reducing the oedema. Some hospitals are having the practice of this application. Epsom salts have an ability of absorbing or removing the water content through skin; hence reduce the oedema which is scientifically proved.

The application of Magnesium sulphate (Epsom salt) alone may cause skin irritation so any of the skin softeners also should apply with this; preferably Glycerine used. Glycerine is a thick liquid that has a variety of uses. It is capable of softening skin and it will help to nourish the skin tissues.4

The combination of magnesium sulphate and glycerine application on a limb oedema with help of roller bandage and followed by limb elevation may help in reduction of swelling and nourishment of skin as evidenced by studies. The nursing interventions should be meaningful and affordable by the client in terms of this aspect this study is relevant to the profession.

6.2 NEED FOR THE STUDY

Superficial Thrombophlebitis which occurs in about 65% of all patients receiving intravenous therapy, deep vein Thrombophlebitis occurs at least 5% of surgical patients.5

In hospitalized individuals, the incidence of venous thrombosis varies considerably, from 20% to 80%, and the incidence of Deep vein thrombosis is estimated to be about 80 cases per 100,000 populations annually. Superficial Thrombophlebitis is very common in hospitalized patients, but frequency is not known precisely because many cases go unreported and untreated. Deep vein thrombosis frequency also is not known precisely because of misdiagnoses.6

In the year 2004, the annual hospital report of Kerala, stated that the incidence of Thrombophlebitis was (78%) in ICU as compared to (30%) in general wards. The study highlighted the cause as lack of physicians, nurses and poor standard of care provided by health care personnel.7

A study was carried out on the clinical importance, diagnosis, incidence, and pathogenesis of peripheral vein infusion Thrombophlebitis, including catheter-related and patient-related risk factors. The study reviewed the evidence linking thrombosis, particularly prothrombotic states such as the inherited thrombophilic disorders, with peripheral vein infusion Thrombophlebitis. Peripheral vein infusion Thrombophlebitis occurs in 25% to 35% of hospitalized patients with peripheral intravenous catheters and has both patient-related implications (e.g., sepsis) and economic consequences (e.g., extra nursing time). Although duration of catheterization, catheter-related infection, and catheter material are important risk factors for peripheral vein infusion Thrombophlebitis, patient-related risk factors are not well elucidated.8

If Thrombophlebitis is in a vein just under your skin (superficial vein), complications are rare. However, if the clot occurs in a deep vein you may develop a serious medical condition known as deep vein thrombosis. If that happens, the risk of serious complications is greater. Complications may include: pulmonary embolism and heart attack or shock.

A study was conducted on the importance in prevention of Thrombophlebitis, such as care against traumatisation of vessels, prevention of infection, control of epidermophytosis, free movement in bed, early ambulation, deep respiratory exercises and the avoidance of the latter in Thrombophlebitis to prevent pulmonary embolism. Attention was called to the highly controversial nature of the measures used in the treatment of Thrombophlebitis; some measure are, the application of heat and cold, the use of leeches, prolonged rest, free exercise, early ambulation, dependent and elevated position of the extremity, lumbosacral sympathetic block, prophylactic venous ligation and the use of anticoagulant agents are proved effective in reducing oedema.

The prevention of Thrombophlebitis is very much important in hospital set up. The nurses have more responsibility to prevent the occurrence and complication related to Thrombophlebitis. Special attention should be carried out for this purpose. The limb oedema may cause immobility, tenderness, infection, fear and anxiety related to disease condition, so reducing the oedema also important part of nursing care.

Magnesium sulphate (Epsom salt) is easily available in as a pharmaceutical form. It is cheapest and more effective in reducing oedema. The cost effective care also one of the main concepts of quality of nursing care. The cost effective management is necessarily carried out to reduce oedema and anxiety related to care.

In a randomized double blind study on patients with oedema treated with one of the following, magnesium sulphate (Epsom salt) and hot application. The result revealed that there is more effectiveness of magnesium sulphate, in reducing oedema than hot application.9

Thrombophlebitis may lead to dry, scaly and disntegrity of the skin. In order to prevent complications of skin nurses should aware about the managements like medications, moisturizing creams and application of glycerine

From the above information researcher has realized that there is high prevalence of Thrombophlebitis among the patients with intravenous therapy. There is a management for the limb oedema with the combination of the magnesium sulphate and glycerine. The method is also very feasible and less expensive. These factors made researcher to design a study to assess the effectiveness of application of combination of magnesium sulphate and glycerine dressing on management of limb oedema.

6.3 STATEMENT OF THE PROBLEM

A study to assess the effectiveness of application of combination of magnesium sulphate and glycerine dressing on management of limb oedema among patients with Thrombophlebitis in a selected hospital, Bangalore.

6.4 OBJECTIVES1. To assess the level of limb oedema among patients with Thrombophlebitis before the intervention.2. To assess the level of limb oedema among patients with Thrombophlebitis after the intervention.3. To compare the pre test and post test level of limb oedema among patients with Thrombophlebitis.4. To associate the pre-test level of limb oedema among patients with Thrombophlebitis with their selected demographic variables.

6.5 OPERATIONAL DEFINITIONS

1. Effectiveness:The degree to which level of limb edema is reduced after the application of dressing.

2. Magnesium sulphate and glycerine dressing: It refers to the application of roller bandage coated with 20 grams of magnesium sulphate diluted in 100 ml of glycerine that is applied on the limb oedema. Magnesium sulphate is crystal like substance which helps to reduce the oedema and glycerine is a thick liquid which help to moisturize and nourish the skin.

3. Limb oedema:Swelling present in either upper or lower extremities.

4. Thrombophlebitis:Inflammation of vein followed by formation of clot after application of intravenous infusion.

6.6 ASSUMPTIONS

1. Limb oedema may vary among patients with Thrombophlebitis.2. Combination of magnesium sulphate & glycerine application may reduce degree of limb oedema.

6.7 RESEARCH HYPOTHESIS

H1 There will be a significant difference in the mean pre test and post test level of limb oedema.H2 There will be significant association between the pre test levels of limb oedema among the patients with Thrombophlebitis with their selected demographic variables.

6.8 REVEIW OF LITERATURE

A literature review is summary of previous research on a topic which can be either a part of a large report of a research project, a thesis or bibliographic essay that is published separately in scholarly journal. The purpose of literature review is to convey the reader what knowledge and ideas have been established on topic and what are the strength and weaknesses. It allows the reader to bring up to date reading the state of research in the field and familiarizes the reader with any contrasting perspectives and view point on the topic. There are many reasons for beginning a literature review before starting a research paper.

A comparative study was carried out on the incidence of Thrombophlebitis following the use of two types of cannulae. There was a significantly lower incidence of Thrombophlebitis in the Biovalve group (17%) compared to the Vialon group (60%) at the end of seven days (p < 0.001). 10 A prospective study was carried out on the frequency of Thrombophlebitis and bacterial contamination of cannulas associated with four commonly used intravenous cannulas of differing length and chemical composition. For all cannulas the frequency of Thrombophlebitis increased significantly with time. It was suggested that infusion Thrombophlebitis could be eliminated as a clinical problem by the use of intermittent short duration intravenous infusions.11 The occurrence of Thrombophlebitis in a coronary care unit was studied in relation to the use of short plastic intravenous cannulae. The incidence of Thrombophlebitis was 51% in cases where cannulae were used for continuous infusion of glucose (5%) and (13%) for cannulae which were locked after the injection of heparin. Only one case of infectious Thrombophlebitis was seen. The other cases of Thrombophlebitis had a chemical or mechanical aetiology. Replacement of glucose (5%) by a Nacl (09%) solution for continuous infusion reduced the incidence of Thrombophlebitis to (33%).12A randomized trial of two catheter materials, with consideration of 21 potential risk factors, to identify risk factors for infusion related phlebitis with peripheral intravenous catheters. The use of peripheral intravenous catheters made of peu-vialon appears to pose the same risk for catheter-related infection as the use of catheters made of Fep-Teflon, and Peu-vialon can permit longer cannulation with less risk for phlebitis. 13 A prospective double-blind randomized study was conducted in 40 patients with infusion-related Thrombophlebitis. The study concluded that transdermal glycerine was useful therapy for infusion-related Thrombophlebitis showing evidence of anti-inflammatory and analgesic effect. 14 A randomized double-blind study, 197 patients with atopic dermatitis were treated with one of the following: a new moisturizing cream with (20%) glycerine, its cream base without glycerine as placebo or a cream with (4%) urea and (4%) sodium chloride.. In conclusion, a glycerine containing cream appears to be a suitable alternative to urea/sodium chloride in the treatment of atopic dry skin.15 A questionnaire study was set up to assess the perceptions of risk factors for infusion phlebitis among Swedish nurses, as their concepts of these factors may influence the incidence. A majority of the nurses believed that insertion of a peripheral venous catheter in the forearm and catheter rotation within 48 hours was protective. These measures were not supported in recent studies and guidelines. Surveillance of the educational level of staff, who inserts peripheral venous catheters, was an important tool for reducing the incidence of infusion phlebitis.16 A study was carried out to determine the incidence of deep vein thrombosis (DVT) in patients diagnosed with superficial Thrombophlebitis (STP) after presenting to an outpatient DVT service. A total of 79 patients were diagnosed with STP after the exclusion of DVT with the diagnostic protocol. The incidence of a subsequent diagnosis of DVT on 6-month follow-up was three out of 79 patients (4%, 95% and 0.8% to 11%). 17 A community-wide study was conducted in 16 short-stay hospitals in Metropolitan Worcester, to examine the incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism in patients hospitalized between July 1, 2003, and December 31, 2004. Extrapolation of the data from that population-based study suggested that there were approximately 170,000 new cases of clinically recognized venous Thromboembolism in patients treated in short-stay hospitals in the United States each year.18 A prospective cohort study was conducted to determine the incidence, clinical presentation, and risk factors of deep venous thrombosis (DVT) in a high-risk group of ICU patients receiving DVT prophylaxis. In that study, the incidence of DVT in a group of high-risk ICU patients receiving DVT prophylaxis was (12%). Since scans in patients without signs or symptoms suggestive of DVT were abnormal in only (3.6%) of patients, venous scans should be performed only in patients with features suggestive of DVT or pulmonary embolism.19 7. MATERIALS AND METHODS OF STUDY:

7.1 SOURCE OF DATA: The data will be collected from patients with Thrombophlebitis admitted in a selected hospital, Bangalore.

7.2 METHOD OF DATA COLLECTION:i) Research designPre Experimental one group pre test- post test design.20

ii) Research variablesIndependent variables: Combination of magnesium sulphate and glycerine dressing. Dependent variables: The level of limb oedema among patients with Thrombophlebitis.Demographic variables: Age, sex, education, family income, duration of hospitalisation, occupation, diet and diagnosis of patients with Thrombophlebitis.

iii) SettingsThe study will be conducted in K.C.G. Hospital, Bangalore.

iv) Population The population of the study will be all the patient with Thrombophlebitis in K.C.G. hospital, Bangalore.

v) Sample The sample consists of the patients who fulfil the inclusion criteria and the sample size is 60.

vi) Criteria for sample selection Inclusion criteria: The patients with Thrombophlebitis. Patients with pitting oedema. Both male and female patients above 18 years of age.

Exclusion criteria: The patient who are not willing to participate the study. The patients who are having limb fracture.

vii) Sampling technique Non probability convenience sampling technique.

viii) Tool for data collectionA structured questionnaire and pitting oedema scale are used as tool.SECTION-A: Questions related to demographic variables consisting of age, sex, education, family income, occupation, diet, duration of hospitalisation and diagnosis. SECTION- B: Pitting oedema scale to assess the level of limb oedema.

ix) Procedure for data collectionAfter obtaining permission from the concerned authority and informed consent from the samples, the investigator will collect the data pertaining to demographic variables.

The study will be conducted in the following phases, PHASE 1: Pre test level of limb oedema will be assessed using pitting oedema scale.PHASE 2: 20gram of magnesium sulphate diluted in 100 ml of glycerine and this combination applied on limb oedema with help of roller bandage and the limb will be elevated. This procedure will be repeated two times in a day. The first dressing will be applied for four hours followed by second application for the next four hours. PHASE 3: After second application of intervention the post test level of limb oedema will be assessed by using the pitting oedema scale.

x) Plan for data analysisThe data collected will be analyzed by using descriptive and inferential statistics.Descriptive statistics: Frequency and percentage distribution will be used to describe demographic variables.Mean and standard deviation will be used to analyse the pre test and post test level of limb oedema among the patient with Thrombophlebitis.Inferential statistics: Wilcoxens test will be used to compare the pre test and post test level of limb oedema among patient with Thrombophlebitis, Chi-square test will be used to associate the pre test level of limb oedema among patients with Thrombophlebitis with their selected demographic variables.21

xi) Projected out comes After application of combination of magnesium sulphate and glycerine dressing on oedema of the limb there will be gradual reduction of limb oedema. This will help to reduce complications of Thrombophlebitis.

7.3 Does the study require any investigations or interventions or other human or Animals?Yes, the application of a combination of magnesium sulphate and glycerine dressing will be administered as an intervention for management of limb oedema.

7.4 Has ethical clearance been obtained from your institution? Yes, permission will be obtained from the concerned authorities of the institution and formal consent will be taken from the samples. Confidentiality and privacy of data will be maintained

8. LIST OF REFERENCES1. Tortora, Derricson. Principle of Anatomy and Physiology. 11th edition.USA: Wiley Publications; 2007.1. Suzanne C, Smeltzer. The text book of Medical surgical Nursing. 10th edition. Philadelphia: LWW Publications;1996.1. Joyce M Black, Jane Hawkis. Medical surgical Nursing. 8th edition. India: Elsevier Publications; 2009.1. Julith C. Evan. How Epsom Salts helps to reduce swelling. Alternative health. Available from http://www.care2.com/greenliving/use-epsom-salts13wonderful way.html.1. Sharon Mantik Lewis, Margaret Mclean, Shannon Ruff Dirkson. Medical Surgical Nursing. 6th edition. Missouri: Mosby publications; 2004.1. Thrombophlebitis. Medical disability advisor. http://www.mdguidelines.com/ Thrombophlebitis.1. Balachandran A. Hospital care. Arogya Mazika. Volume 3. Kollam: Manorama publications; 2000.1. Uslusoy E, Metes. Predisposing factors to phlebitis in patients with peripheral intravenous catheters. Health science institute. Available on:www.ncbi.nlm.gov/pubmed145255568.1. Juhvan, Charlie N. The treatment of swelling. Available from http://www. annual.com/treatment/-swelling/epsomsalts/ 3434.1. Gupta a, Mehta y, Juneja R, Trehan N. The effect of cannulae material on the incidence of peripheral venous Thrombophlebitis. Avail from: http://www.ncbi.nlm.nih.gov/pubmed/17924895.1. Jack collin, F. L. Constable, Christine Collin and I. D. A. Johnston. Thrombophlebitis and infection with various cannulas. Royal victoria infirmary. Newcastle upon tyne. United kingdom. Available on http://www.ncbi.nlm.nih.gov/pubmed/179248951. P. J. Van Den Broek, M. M. De herder-Swinkels, B. G. Moffie, H. C. Van den Berg, J. Hermans. Thrombophlebitis. Anz journal of surgry 2003oct;73(10):794-6. Available from: http://pmj.bmj.com/content/69/807/37 abstract1. Lodn m, Andersson ac, Anderson 13. Dennis G. Maki, Marilyn Ringer. Risk factors for infusion related phlebitis with small venous peripheral catheters. Avail on: www.annals.com1. J.R. Berrazueta, J.J. Poveda. The anti- inflammatory and analgesic action of topical glycerine in the treatment of infusion related Thrombophlebitis. Anz journal of surgery 2003 oct;73(10):794-6.1. Anderson C, Bergbrant im, Frdin T. The cochrane central register of controlled trials. The cochrane collaboration. Available on http://onlinelibrary.wily.com/o/clcentral/article/042/ cn-00408640/frame. html1. P. Paulseno. Perception of risk factors for infusion phlebitis among swedish nurses. Journal american acad nurse practice. 2008 april 20;4:172-80.1. Dewar C, Panpher S. Incidence of deep vein thrombosis in patients diagnosed with superficial thrombophlebitis after presenting to an emergency department outpatient deep vein thrombosis service. Emerg Med Journal. 2010 Oct;27(10):758-61.1. Anderson FA Jr, Wheeler HB, Goldberg RJ. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. Arch Intern Med. 1991 May;151(5):933-8. Available on www.Pubmed.com1. Manik PE, Andrews L, Malini B. The incidence of deep venous thrombosis in ICU patients. Vascular journal 1997 march 3. Available on: www.ncbi.nlm.gov/pubmed1451. Polit F, Beck T. Nursing research generating and assessing evidence for nursing practice.8th edition: Wolters kluwer;2008.1. Barbara H. Statiscal methods for health care research inferential statistics. 3rd edition: lippincot; 1997.

09. Signature of the candidates :10. Remarks of the guide :11.1 Name and designation of the guide: Mrs. PRASANNA.K HOD & Associate Professor11.2 Signature of the guide:11.3 Co-guide (if any): Mr. VENKATESAN.B11.4 Signature of co-guide:11.5 Head of the department: Mrs. PRASANNA.K11.6 Signature :

12.1 Remarks of the principal:12.2 Signature of the principal :

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