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Walking Through the Research Process – An Aromatherapy Study: One Step at A Time

Renee Trambert, MPH, RN, CPBN-IC

Disclosure

Beekley Manufacturer supplied the aromatherapy tabs. Beekley had no input to the design, conduct or outcome of the study.

There are no disclosures related to this study.

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Carol W. and Julius A. Rippel Breast Center

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Carol G. Simon Cancer Center

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Background

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Approximately 232,340 women will be diagnosed with breast cancer in the USA this year.

Breast biopsy is the standard diagnostic procedure for diagnosis.

Biopsies are anxiety provoking for patients!

Anti-anxiety Meds• alprazolam• diazepam• benzodiazepine

Procedure Delayed or Canceled

Can escalate to: • Panic Attack• Vasovagal

Response

Anxious Patient

http://www.riversideonline.com/health_reference/Test-Procedure/MY00301.cfm?sa=X&ved=0CDoQ9QEwEmoVChMI0ZX6rOv9xgIVhWk-Ch2ZjgIx

Traits needed to succeed as a nurse researcher.

Understand the commitment Focus Perseverance Self Driven Choose the right team Attention to detail Overcome obstacles Ability to make mid-course corrections Ability to follow through

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Research Process

Research Question Putting team together PICO: Defining the population and intervention to be studied Literature Search Incorporation of the Nurse Theorist Design: objectives, comparison, variables, statistical

analyses, sample size Develop Forms Resources IRB Approval Statistical consult Findings and Dissemination

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Research Question

Biopsies are anxiety provoking for patients. Culture of Healing “How can nurses reduce anxiety for people having breast

biopsies?”

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Aromatherapy

For centuries aromatherapy has been used to reduce anxiety.

This study uses a unique deliver system to quantify the reduction of anxiety using aromatherapy.

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Study Title

A randomized placebo-controlled comparative trial of essential oils to reduce anxiety in women undergoing image-guided breast biopsies using the modalities of Mammography, Ultrasound and Magnetic Resonance Imaging (MRI) guidance.

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http://www.google.com/url?url=http://www.carcabin.com/lavender-field-abbey-of-senanque-near-gordes-provence-francejpg/1.bp.blogspot.com*_ZRxEeZSV7O0*Rg1xIBNRaHI*AAAAAAAADY4*YaLxtiTPj4A*s200*Lavender%20Field%20Abbey%20of%20Senanque%20Near%20Gordes%20Provence%20France.jpg/&rct=j&frm=1&q=&esrc=s&sa=U&ei=d30HVNTQFonJuAT-vYKoAg&ved=0CCwQ9QEwCzgU&usg=AFQjCNGqqmQFRLRd0l2PwjS79b7dNAzvQw

Research Process

Research Question Putting team together Literature Search Design: objectives, comparison, variables, statistical

analyses, sample size Define Population to be studied Develop Forms Resources IRB Approval Statistical Consult Findings and Dissemination

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Research Team

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Renee Trambert, MPH, RN, CBPN-ICPrincipal Investigator

Betty Wu, RN, CBPN-ICNurse Navigator

Nimisha Mehta, MDResident

Paul Friedman, DOMedical DirectorCarol W. and Julius A. Rippel Breast Center

Diana Caruso, RTCoordinator Carol W. and Julius A. Rippel Breast Center

Mildred Ortu Kowalski, PhD, RN, NE-BC, CCRPNurse Researcher

Research Process

Research Question Putting team together Literature Search Define Population to be studied Design: objectives, comparison, variables, statistical

analyses, sample size Develop Forms Resources IRB Approval Statistical Consult Findings and Dissemination

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Literature Review Shinn-Lathrope Health Science Library at Morristown

Medical Center

CINHAL, Pubmed

Librarians: Janina Kaldan, Library ManagerYi Zhou, Librarian

Mary Loughran, RN was used as an resource because of her previous research experience with aromatherapy

Beekley Manufacturer

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Key Findings from Lit Review

Anxiety is one of the most common problems patients face before an image- guided core biopsy

Methods to reduce anxiety and enhance adaptation are paramount to nursing care

Reduced anxiety may improve patient’s outpatient hospital experience

Documented results include reduced anxiety and improved mood with aromatherapy

Aromatherapy has been shown effective in a variety of clinical settings

Delivery is challenging Aromatabs are easy, convenient delivery system

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Aromatabs®

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• Small foam-like tab (1 in X 1 ½ inches) on a larger cardboard backing (2 inch X 2 ½ inches)

• Hypo-allergenic adhesive backing• Tab is placed on the gown, by the shoulder• MDS information was provided to the IRB• Beekley Manufacturer provided the tabs and

matched placebo

Research Process



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PICO: Population, Intervention, Comparison and Outcomes

Populations: Females, 18 – 80 years, no prior personal history of breast cancer, having breast biopsy at Carol G. Simon….Ripple….MMC

Intervention: Aromatherapy Tab using a unique delivery system

Comparison: Three groups of aromatherapy including: Lavender Sandalwood (Group A), Orange/Peppermint (Group B) compared to a Matched Control Delivery System (Group C)

Outcome: Reduction of Anxiety as measured by the State-Trait Anxiety Inventory (STAI) for adults Self-Evaluation Questionnaire (Spielberger, 1977)

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PICO

Define Population All women scheduled for an image guided core biopsy at MMC

meeting eligibility criteria Consenting women between the ages of 18-90 Only English speaking women due to tool uses Women who are not pregnant Alert and oriented women agreeable to receiving tabs Exclusion:

• Allergy to plants, seasonal allergies, problems breathing through nose, history of asthma, history of seizures

• Non-English speaking• Women who are pregnant• Cognitively or decisionally impaired• Women who have history of breast cancer

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Plan versus Actual Enrollment

• Plan: September 30, 2013 to June 30, 2014• Recruitment rate of approximately 10 cases/month

• Important for funding

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Sample Size• N = 87• Based on alpha level of 0.05, power = 80%, and a medium effect size.• The effect size is estimated from a post-operative study (Fayazi, et al, 2011).

Showed an eight point difference in anxiety.

Out of 21 counties in NJ, Morris County is 2nd highest annual incidence rate of breast cancer (147.8), second only to Hunterdon County 156.3. The lowest rate is observed in Hudson county with 109.8.9 (2005-2009 rate period).

Feasibility:• MMC = 1478 breast biopsies/year• 547 stereotactic guided core biopsies a year• 258 MRI guided core biopsies a year• 673 ultrasound guided core biopsies annually• Duration of trial will be 9 months• September 30, 2013 to June 30, 2014• Recruitment rate of approximately 10 cases/month

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Research Process



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To explore the use of aromatherapy, via aromatherapy tabs, to enhance adaptation to anxiety during image–guided breast biopsy.

To investigate the effects of lavender/sandalwood (Group A) or the effect of orange/peppermint (Group B) aromatherapy, compared to a matched control delivery system (Group C), in the reduction of anxiety and related physiological changes in women.

To evaluate differences in anxiety and vital signs with the aromatherapy tabs verses placebo.

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Objectives

Outcome

Will aromatherapy enhance adaptation to anxiety associated with breast biopsy?

Anxiety as measured by Spielberger State Trait Inventory

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State Anxiety Inventory (STAI)

The STAI measures state anxiety Difference between state and trait anxiety Validity and Reliability of the instrument

• Validity - over 5000 tests• Reliability – test/re-test, correlation

Licensing though Mindgarden™ The Trait Anxiety Inventory Scale = 20 questions The State Anxiety Inventory Scale = 20 questions Paper and pencil survey

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Research Process



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Brochure

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Data Collection Form

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Research Process



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Resources

Funding was provided by MMC Women’s Foundation Mini Grant

Beekley provided aromatabs and placebo Dr. Rami Bustami provided the randomization list Copying of consents, information sheets and surveys Information given to the entire Breast Center Staff

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Research Process



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IRB Approval

Nursing Research Council approval Submit Institutional Review Board Documents: Protocol,

Consent Form, Information Forms, STAI Survey Forms, Brochure, MSD Sheets, application, sub-investigator forms, CV, CITI training certification

Full IRB review – PI present at meeting Approved via letter Use of Stamped Consent Form

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Research Process



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Baseline Physiologic and Outcome Measures Variable Lavender Orange Placebo p ValueSystolic BP median (range) 118 (99-169) 128 (94-148) 118 (91-146) 0.25

Diastolic BP median (range) 70 (56-101) 76 (60-97) 70 (53-96) 0.20

Pulse median (range) 74 (54-87) 75 (60-100) 73 (55-133) 0.32

Respirations median (range) 16 (12-24) 16 (12-20) 16 (12-20) 0.51

State median (range) 48 (22-66) 43 (22-73) 43 (23-66) 0.34

Trait median (range) 37 (23-61) 32 (20-64) 30 (23-59) 0.30

Outcomes

Change in State median (range) -11 (-35--4) -6 (-33-10) -4 (-28-23) 0.050

Change in Systolic median (range) 0 (-32-26) 0 (-22-25) 4 (-23-22) 0.87

Change in Diastolic median (range) 0 (-16-14) 1 (-20-18) 1 (-21-16) 0.98

Change in Pulse median (range) 1 (-13-13) -4 (-18-14) -2 (-15-15) 0.066

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Research Process



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Findings

Demographics State Pre and Post Physiological Measures

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Demographics

Variable Lavender Orange Placebo p Value

Age (years) Mean ± SD 52.4 ±10.6 50.3± 10.5 47.5± 8.9 0.21

White Race % 90% 83% 96% 0.26

Private Insurance % 93% 96% 93% 0.83

Education % 0.74High School 16% 7% 15%

College 56% 56% 44%

Graduate orpost-graduate

28% 37% 41%

Type of Biopsy % 0.54MRI 7% 7% 4%

Stereotactic 62% 47% 68%

Ultrasound 31% 47% 29%

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Box and Whisker Plots: Change in State Scoreby Group

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Overall Comparison : p = 0.050

Median

75th%ile = -4

25th%ile = -22

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75th%ile = 2

25th%ile = -13

75th%ile = -1

25th%ile = -12

-6 -4

Lavender vs. Placebo (p = 0.032) Lavender vs. Orange (p = 0.038) Orange vs. Placebo (p = 0.95)

Results

A reduction in anxiety as measured by the STAI was observed between pre and post biopsy in all groups

The difference was statistically significant and clinically meaningful

Reduction in anxiety was observed most in Lavender, then Orange and least in Placebo

Lavender showed a statistical difference compared to placebo.

Lavender & Orange were statistically different

Orange did not show a statistical difference compared to placebo

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Conclusions

Lavender was statistically significant and clinically meaningful in reducing anxiety for women having breast biopsies

Orange reduced anxiety less than lavender (ns)

In this study, physiological measures did not change before and after the biopsy

A placebo effect may explain reduced anxiety in the Placebo Group; or, the reductions in anxiety may reflect natural reaction to completion of the biopsy

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Practice Change

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Dissemination

MMC Nursing Research Council (September 2014) MMC Atlantic Center for Research Conference-Podium Presentation

(June 2015) American Credentialing Center (ANCC) Magnet Conference in

Atlanta, Ga Conference – Podium Presentation- (October 2015) New Jersey State Nurses Association-Podium Presentation-

(December 2016) Poster Presentation at the Southern Chapter of the Research

Consortium for the NJ Council of Magnet Organizations (April 2017) Published in Worldviews of Evidence-based Nursing ( Trambert,

Kowalski, Wu, Mehta & Friedman, 2017) with a continuing education component.

Published as a story “Mini-Grant” in the “Journal of the Foundation for Morristown Medical Center” in February 2019. (Laura Deal, writer for Foundation)

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Tips for Your Research Journey

1. Think of the Real issue/problem that will enhance patient experience

2. Find a mentor where you work

3. Be passionate about your Research and find others who are like yourself

4. Process is always longer than you think, but worth the effort

5. Realize the changes you make can affect the world in your little corner

6. Research drives our patient practice

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Acknowledge

Women who participated Managers: Diana Caruso, April Dixon Women’s Foundation for Morristown Medical Center Beekley Manufacturer Nursing Research Council Rami Bustami & Stephanie Chiu for statistical support Janina Kaldan, Library Support Jahleel Patterson for graphic assistance Mary Loughran, MSN, RN, AHN-BC

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Thank you!

New Yorker Magazine cartoon48

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Walking Through the Research Process – An Aromatherapy Study: One Step at A Time��Renee Trambert, MPH, RN, CPBN-ICDisclosureCarol W. and Julius A. Rippel Breast CenterCarol G. Simon Cancer CenterBackground Anxious PatientTraits needed to succeed as a nurse researcher.Research ProcessResearch Question Aromatherapy Study Title Research ProcessResearch TeamResearch ProcessLiterature ReviewKey Findings from Lit ReviewAromatabs®Research ProcessPICODefine PopulationPlan versus Actual EnrollmentSample SizeResearch ProcessObjectivesSlide Number 25OutcomeState Anxiety Inventory (STAI)Research ProcessBrochureSlide Number 30Data Collection Form Research ProcessResourcesResearch ProcessIRB Approval Research ProcessBaseline Physiologic and Outcome Measures Research ProcessFindingsDemographicsBox and Whisker Plots: Change in State Score� by GroupResultsConclusionsPractice ChangeDisseminationTips for Your Research JourneyAcknowledgeThank you!