Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- West Virginia University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Examine Feasibility (Eligible Participant Recruitment)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The person enrolling is masked to the assignment. No need to mask for aroma inhaler as participants receive materials through the mail and do not interact with other participants. No sham inhaler is used.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention Group
Adults (>18 years) who are currently receiving treatment for substance use disorder (SUD) in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
Intervention: Aroma Inhaler with Bergamot essential oil (Other)
Control Group
Adults (>18 years) who are currently receiving treatment for SUD in the outpatient treatment program at West Virginia University Chestnut Ridge Center (WVUCRC) (n = 340 approx.). In addition, participants can be at any level of treatment, including peer recovery coach program. Inclusion criteria are patients diagnosed with SUD who have completed intensive acute phase 1 treatment, and who desire to pursue continuous recovery phases (per facility protocol). All participants must be alert and oriented, provide written consent, and be able to read and write English. Exclusion criteria are patients diagnosed with severe mental illness (who cannot consent to participate), have a medical history of asthma or other serious respiratory disease, and known allergy to citrus.
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)
Investigators
Marian Reven
Assistant Professor, Principle Investigator
West Virginia University