Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05660434
Study type Interventional
Source West Virginia University
Contact
Status Completed
Phase N/A
Start date September 5, 2022
Completion date March 15, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05338268 - Substance Use and Loneliness N/A
Completed NCT03954184 - E-health Implementation (Iowa) N/A
Completed NCT04098614 - Barriers to Substance Use Disorder Recovery N/A
Completed NCT03590106 - Cardiac Surgery Peer Recovery Support Program N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Terminated NCT03517111 - The Impact of a Parenting Intervention on Latino Youth Health Behaviors N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04401215 - Technologically-Augmented Referrals to Mitigate Addiction Consequences N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Active, not recruiting NCT02382042 - Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans N/A
Terminated NCT01356667 - Drum-Assisted Therapy for Native Americans N/A
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Completed NCT00708890 - Twelve Step Based Self-help Groups for Substance Related Disorders N/A
Active, not recruiting NCT04048850 - Zepatier in Patients With Substance Use
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2
Recruiting NCT06094972 - The Effectiveness of A-CRA in Compulsory Institutional Care for Youth N/A