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Completed

NCT Number: NCT05660434

Using Aromatherapy in Substance Use Disorder

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.

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Key information

Conditions

Substance Use Disorders Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aroma Inhaler with Bergamot essential oil

Other

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.

Primary outcomes

  1. Examine Feasibility (Eligible Participant Recruitment)

    Time frame: Up to 18 months

    Determine feasibility by assessing the number of eligible participants recruited.

  2. Examine Feasibility (Eligible Participant Enrollment)

    Time frame: Up to 18 months

    Determine feasibility by assessing how many eligible participants enroll.

  3. Examine Feasibility (Participant Retention)

    Time frame: Up to 18 months

    Determine feasibility by assessing count of participants retained.

  4. 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

  1. Change in Perceived Comfort Level

    Time frame: Pre test prior to day 1 to Post test after 1 week

    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 agreement with the statement and 6 being the most agreement with the statement. The investigators are looking at a change in comfort from before the intervention to after the intervention. There were 28 questions in this scale with a total score between 28 and 168. There are 3 subscales of Relief (8 questions) , Ease (10 questions), and Transcendence (10 questions). A higher score post test cumulative or as subscales indicates more agreement with the statements of overall comfort and its subscales.

  2. Change in Perceived Ease Level

    Time frame: Pre test prior to day 1 to Post test after 1 week

    The concept of ease is measured using the Ease measure. This is assessed using a Likert scale from 1 to 4. There is only one score reported for this measure, no subscales. The investigators are looking at a change in ease from before the intervention to after the intervention. There are 20 questions with a range of scores between 20 and 80. The lower score indicates less agreement with the statement about ease. A higher score indicates more agreement. A higher score post test indicates an improvement.

  3. Change in the Depression, Anxiety, and Stress Scale (DASS-21)

    Time frame: Pre test prior to day 1 to Post test after 1 week

    The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.

    Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items. 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. Scores range from 0 to 63 with lower score indicating less agreement with statements and 63 indicating higher score in agreement with statements. A lower score indicates improvement in DASS.

  4. Visual Analogue Scale to Assess Daily Perceived Comfort

    Time frame: 7 days

    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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Collaborators

  • West Virginia Nurses Association

Registry information

Official study title

Using Aromatherapy for Comfort, Ease, and Stress for Adults Being Treated for Substance Use Disorder in North Central Appalachia: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2022
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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