Substance Use Disorders
Conditions
Keywords
social and behavioral, randomized, questionnaires, aroma therapy
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.
Interventions
OTHERAroma 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.
Sponsors
West Virginia Nurses Association
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The person enrolling is masked to the assignment. No need to mask for aroma inhaler as participants receive materials through the mail and do not interact with other participants. No sham inhaler is used.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Examine Fidelity of the Intervention | Up to 7 days | Determine fidelity by assessing the count of participants that completed the intervention as directed as shown in the daily logbook. |
| Examine Feasibility (Eligible Participant Recruitment) | Up to 18 months | Determine feasibility by assessing the number of eligible participants recruited. |
| Examine Feasibility (Eligible Participant Enrollment) | Up to 18 months | Determine feasibility by assessing how many eligible participants enroll. |
| Examine Feasibility (Participant Retention) | Up to 18 months | Determine feasibility by assessing count of participants retained. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Comfort Level | 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. |
| Change in Perceived Ease Level | 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. |
| Change in the Depression, Anxiety, and Stress Scale (DASS-21) | 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. |
| Visual Analogue Scale to Assess Daily Perceived Comfort | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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.
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. | 45 |
| 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. | 55 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Never obtained study materials | 2 | 1 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 55 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 52 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Female | 26 Participants | 35 Participants | 61 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 55 |
| other Total, other adverse events | 0 / 45 | 0 / 55 |
| serious Total, serious adverse events | 0 / 45 | 0 / 55 |
Outcome results
Primary
Examine Feasibility (Eligible Participant Enrollment)
Determine feasibility by assessing how many eligible participants enroll.
Time frame: Up to 18 months
Population: The numbers above reflect all patients that were deemed eligible per criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Examine Feasibility (Eligible Participant Enrollment) | 45 Participants |
| Control Group | Examine Feasibility (Eligible Participant Enrollment) | 55 Participants |
Primary
Examine Feasibility (Eligible Participant Recruitment)
Determine feasibility by assessing the number of eligible participants recruited.
Time frame: Up to 18 months
Population: The numbers above reflect all patients that were deemed eligible per criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Examine Feasibility (Eligible Participant Recruitment) | 45 Participants |
| Control Group | Examine Feasibility (Eligible Participant Recruitment) | 55 Participants |
Primary
Examine Feasibility (Participant Retention)
Determine feasibility by assessing count of participants retained.
Time frame: Up to 18 months
Population: 3 participants never obtained study materials
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Examine Feasibility (Participant Retention) | 43 Participants |
| Control Group | Examine Feasibility (Participant Retention) | 54 Participants |
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.
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Examine Fidelity of the Intervention | 45 Participants |
| Control Group | Examine Fidelity of the Intervention | 55 Participants |
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 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.
Time frame: Pre test prior to day 1 to Post test after 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Change in Perceived Comfort Level | Before Intervention | 116.29 score on a scale | Standard Deviation 21.798 |
| Intervention Group | Change in Perceived Comfort Level | After Intervention | 117.91 score on a scale | Standard Deviation 20.599 |
| Control Group | Change in Perceived Comfort Level | Before Intervention | 114.17 score on a scale | Standard Deviation 22.05 |
| Control Group | Change in Perceived Comfort Level | After Intervention | 114.84 score on a scale | Standard Deviation 21.683 |
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. 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.
Time frame: Pre test prior to day 1 to Post test after 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Change in Perceived Ease Level | Before Intervention | 53.04 score on a scale | Standard Deviation 9.925 |
| Intervention Group | Change in Perceived Ease Level | After Intervention | 57.21 score on a scale | Standard Deviation 11.482 |
| Control Group | Change in Perceived Ease Level | Before Intervention | 53.88 score on a scale | Standard Deviation 8.993 |
| Control Group | Change in Perceived Ease Level | After Intervention | 55.58 score on a scale | Standard Deviation 8.212 |
Secondary
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.
Time frame: Pre test prior to day 1 to Post test after 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Change in the Depression, Anxiety, and Stress Scale (DASS-21) | Before Intervention | 20.49 score on a scale | Standard Deviation 11.482 |
| Intervention Group | Change in the Depression, Anxiety, and Stress Scale (DASS-21) | After Intervention | 18.54 score on a scale | Standard Deviation 10.404 |
| Control Group | Change in the Depression, Anxiety, and Stress Scale (DASS-21) | Before Intervention | 20.28 score on a scale | Standard Deviation 10.747 |
| Control Group | Change in the Depression, Anxiety, and Stress Scale (DASS-21) | After Intervention | 21.34 score on a scale | Standard Deviation 10.953 |
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.
Time frame: 7 days
Population: Per Protocol only 25 participants were included in the Intervention group for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Visual Analogue Scale to Assess Daily Perceived Comfort | Day 1 | 66.72 score on a scale | Standard Deviation 18.729 |
| Intervention Group | Visual Analogue Scale to Assess Daily Perceived Comfort | Day 7 | 80.68 score on a scale | Standard Deviation 11.707 |
| Control Group | Visual Analogue Scale to Assess Daily Perceived Comfort | Day 1 | 49.02 score on a scale | Standard Deviation 26.386 |
| Control Group | Visual Analogue Scale to Assess Daily Perceived Comfort | Day 7 | 55.71 score on a scale | Standard Deviation 26.516 |