Substance Use DisordersNCT05660434
Using Aromatherapy in Substance Use Disorder
A study testing Aroma Inhaler with Bergamot essential oil in people with Substance Use Disorders, run by West Virginia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Aroma Inhaler with Bergamot essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have a medical history of asthma or other serious respiratory disease
- Known allergy to citrus.
- Dislike of Bergamot
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
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
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.
Read the 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
- Being tested
- Aroma Inhaler with Bergamot essential oil
- Keywords
- social and behavioral, randomized, questionnaires, aroma therapy
- Medical subject headings
- Substance-Related Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroma Inhaler with Bergamot essential oilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Aroma Inhaler with Bergamot essential oil |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine Feasibility (Eligible Participant Recruitment)
Determine feasibility by assessing the number of eligible participants recruited.
Measured: Up to 18 months
Examine Feasibility (Eligible Participant Enrollment)
Determine feasibility by assessing how many eligible participants enroll.
Measured: Up to 18 months
Examine Feasibility (Participant Retention)
Determine feasibility by assessing count of participants retained.
Measured: Up to 18 months
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.
Measured: Up to 7 days
Secondary outcomes (4)
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 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.
Measured: Pre test prior to day 1 to Post test after 1 week
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. 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.
Measured: Pre test prior to day 1 to Post test after 1 week
Change in the Depression, Anxiety, and Stress Scale (DASS-21)
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.
Measured: Pre test prior to day 1 to Post test after 1 week
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start5 Sep 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia Nurses Association
- Responsible party
- Principal investigator, Marian Reven, West Virginia University
- Investigators
- Marian Reven, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660434
- Sponsor's protocol ID
- 2204562633
- Status last verified
- Jan 2025
- First submitted
- 18 Nov 2022
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be maintained by the primary investigator, and will be analyzed and reported by this individual only.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660434
- Acronym / sponsor ID
- 2204562633
- Conditions
- Substance Use Disorders
- Keywords
- social and behavioral, randomized, questionnaires, aroma therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- West Virginia Nurses Association
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Aroma Inhaler with Bergamot essential oilAdults (>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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have a medical history of asthma or other serious respiratory disease
- Known allergy to citrus.
- Dislike of Bergamot
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aroma Inhaler with Bergamot essential oilThe 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. | Other | Intervention Group |
Primary outcome
Examine Feasibility (Eligible Participant Recruitment)
Time frame: Up to 18 months
Determine feasibility by assessing the number of eligible participants recruited.
Examine Feasibility (Eligible Participant Enrollment)
Time frame: Up to 18 months
Determine feasibility by assessing how many eligible participants enroll.
Examine Feasibility (Participant Retention)
Time frame: Up to 18 months
Determine feasibility by assessing count of participants retained.
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.
4 secondary outcomes
Change in Perceived Comfort Level
Time frame: Pre test prior to day 1 to Post test after 1 week
Change in Perceived Ease Level
Time frame: Pre test prior to day 1 to Post test after 1 week
Change in the Depression, Anxiety, and Stress Scale (DASS-21)
Time frame: Pre test prior to day 1 to Post test after 1 week
Visual Analogue Scale to Assess Daily Perceived Comfort
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Data will be maintained by the primary investigator, and will be analyzed and reported by this individual only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marian Reven, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aroma Inhaler with Bergamot essential oil in people with Substance Use Disorders, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examine Feasibility (Eligible Participant Recruitment) (time frame: Up to 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.