Using Aromatherapy in Substance Use Disorder

Substance Use Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660434
• Other study ID #: 2204562633
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: West Virginia University
• Contact: Marian E Reven, PhD
• Phone: 304-293-3399
• Email: marian.reven[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 SUD treatment program, and to evaluate the feasibility of this type of aroma therapy intervention.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 123
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Aroma Inhaler with Bergamot essential oil
The intervention group will receive an aroma inhaler and logbook to use three times a day for 7 days and complete pre and post surveys for comfort, ease, and stress.

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
West Virginia University	West Virginia Nurses Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examine Feasibility (participant recruitment)	Determine feasibility by assessing the number of participants recruited.	Up to 18 months
Primary	Examine Feasibility (participant enrollment)	Determine feasibility by assessing how many participants enroll.	Up to 18 months
Primary	Examine Feasibility (participant retention)	Determine feasibility by assessing count of participants retained.	Up to 18 months
Primary	Examine Acceptability of the intervention	Determine acceptability by assessing participant feedback through use of a visual analog scale (VAS) where 0 means the least comfortable and 100 means the most comfortable.	Up to 7 days
Primary	Examine Fidelity of the intervention	Determine fidelity by assessing the count of participants that completed the intervention as directed as shown in the daily logbook.	Up to 7 days
Secondary	Change in perceived Comfort level	The concept of comfort is operationalized by the Generalized Comfort Questionnaire (GCQ). This incorporates a Likert scale from 1 to 6 with 1 being the least comfortable and 6 being the most comfortable. The investigators are looking at a change in comfort from before the intervention to after the intervention.	Pre test prior to day 1 to Post test after 1 week
Secondary	Change in perceived Ease level	The concept of ease is measured using the Ease measure. This is assessed using a Likert scale from 1 to 4 with 1 being the least amount of ease and 4 being the highest amount of ease. The investigators are looking at a change in ease from before the intervention to after the intervention.	Pre test prior to day 1 to Post test after 1 week
Secondary	Change in perceived Stress level	The concept of stress is measured using the Depression, Anxiety, and Stress Scale (DASS), short version 21-questions. This is assessed using a Likert scale from 0 to 3 with 0 being the least amount of stress and 3 being the highest amount of stress. The investigators are looking at a change in stress from before the intervention to after the intervention.	Pre test prior to day 1 to Post test after 1 week
Secondary	Visual Analogue Scale to assess daily perceived Comfort	The Visual Analogue Scale (VAS) is used as a daily measure of comfort. It provides validation for the GCQ using a 100mm line where Comfort is rated using a mark on the line between 0 and 100 "I feel as comfortable as possible" with 0 being the least comfortable and 100 being the most comfortable.	7 days