Using Aromatherapy in Substance Use Disorder

NCT ID: NCT05660434

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-03-15

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.

Conditions

Substance Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Aroma Inhaler with Bergamot essential oil

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia Nurses Association

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Marian Reven

Assistant Professor, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marian Reven, PhD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2204562633

Identifier Type: -

Identifier Source: org_study_id