Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Substance Use Disorders
- Sponsor
- West Virginia University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Examine Feasibility (Eligible Participant Recruitment)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The purpose of this clinical trial study is to see if Bergamot, an aroma therapy essential oil, has any effect on comfort, ease, and stress. Participants will be asked to use a bergamot aroma inhaler, which is a small tube about the size of a lipstick container, at least three times a day for one week. Comfort, ease, and stress will be measured with self-report survey at the beginning and at the end of the week. In addition, participants will be asked to complete a daily logbook to record use of the inhaler. The study lasts for one week (7 days). The aims of this study are to explore the effects of Bergamot essential oil on comfort, ease, and stress in adults in a substance use disorder (SUD) treatment program, and to evaluate the feasibility of this type of aroma therapy intervention.
Detailed Description
Statement of purpose: The purpose of the study is to examine the effect of an aromatic intervention using bergamot essential oil on comfort, ease, and stress in adults in a SUD recovery program Research Question: What are differences in comfort, ease, and stress for persons in a substance use disorder program who receive aromatic intervention and for those who do not? Conceptual framework: An integrated theoretical framework combining the theory of comfort (Kolcaba, 2003) and the concept of welcoming ease (Reven, 2022) will be used as theoretical guidance for this study. Aims and Objectives: Specific Aim #1: Evaluate the feasibility and acceptability of an aromatherapy intervention by examining recruitment, enrollment and retention rates, intervention fidelity, and cost analysis. Specific Aim #2: Pilot test bergamot essential oil intervention with adults in a substance use disorder recovery program. Background: Appalachia is at the epicenter of the opioid addiction crisis with hardly a family left untouched by the devastating consequences. Those who make it to recovery programs are often plagued by anxiety and depression. Those in treatment have identified increasing the level of comfort during substance use recovery as vital. Integrating aromatherapy could help improve perception of comfort and reduce stress thus enhancing recovery program progression. Methods: The study uses a parallel-randomized control group comparison design. Data will be collected from participants daily and post intervention. For Aim #1, descriptive and bivariate analysis will be conducted. Statistical assumptions will be tested. Sample demographics will be reported. For Aim #2, descriptive statistics will be used as well as participant recruitment, enrollment, and retention rates. Reasons for non-participation and attrition will be recorded. Percentage of intervention consistency will be calculated and cost of the intervention will be determined. Timeline: The proposed study would begin as soon as grant funding is available with projected timeline being August 2022 to December 2023.
Investigators
Marian Reven
Assistant Professor, Principle Investigator
West Virginia University
Eligibility Criteria
Inclusion Criteria
- •Participants can be at any level of treatment, including peer recovery coach program at West Virginia University Comprehensive Opioid Addiction Treatment (COAT) program
- •All participants must be alert and oriented
- •Provide written consent
- •Able to read and write English
Exclusion Criteria
- •Have a medical history of asthma or other serious respiratory disease
- •Known allergy to citrus.
- •Dislike of Bergamot
Outcomes
Primary Outcomes
Examine Feasibility (Eligible Participant Recruitment)
Time Frame: Up to 18 months
Determine feasibility by assessing the number of eligible participants recruited.
Examine Feasibility (Eligible Participant Enrollment)
Time Frame: Up to 18 months
Determine feasibility by assessing how many eligible participants enroll.
Examine Feasibility (Participant Retention)
Time Frame: Up to 18 months
Determine feasibility by assessing count of participants retained.
Examine Fidelity of the Intervention
Time Frame: Up to 7 days
Determine fidelity by assessing the count of participants that completed the intervention as directed as shown in the daily logbook.
Secondary Outcomes
- Change in Perceived Comfort Level(Pre test prior to day 1 to Post test after 1 week)
- Change in Perceived Ease Level(Pre test prior to day 1 to Post test after 1 week)
- Change in the Depression, Anxiety, and Stress Scale (DASS-21)(Pre test prior to day 1 to Post test after 1 week)
- Visual Analogue Scale to Assess Daily Perceived Comfort(7 days)