Clinical trial NCT05660434: Using Aromatherapy in Substance Use Disorder
Official title: Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: social and behavioral
randomized
questionnaires
aroma therapy
Lead sponsor: West Virginia University
Sponsor class: OTHER
Collaborators: name: West Virginia Nurses Association
First posted: 2022-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Examine Feasibility (Eligible Participant Recruitment)
timeFrame: Up to 18 months
measure: Examine Feasibility (Eligible Participant Enrollment)
timeFrame: Up to 18 months
measure: Examine Feasibility (Participant Retention)
timeFrame: Up to 18 months
measure: Examine Fidelity of the Intervention
timeFrame: Up to 7 days
Secondary outcomes:
measure: Change in Perceived Comfort Level
timeFrame: Pre test prior to day 1 to Post test after 1 week
measure: Change in Perceived Ease Level
timeFrame: Pre test prior to day 1 to Post test after 1 week
measure: Change in the Depression, Anxiety, and Stress Scale (DASS-21)
timeFrame: Pre test prior to day 1 to Post test after 1 week
measure: Visual Analogue Scale to Assess Daily Perceived Comfort
timeFrame: 7 days
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Marian Reven, PhD
role: PRINCIPAL_INVESTIGATOR
References: