- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02191345
The Effectiveness of Guided Imagery for a Nonprofit's Employees
A Randomized Controlled Trial Measuring the Effectiveness of Prerecorded Guided Imagery in Reducing Compassion Fatigue, Burnout, Perceived Stress, and State Anxiety of a Mental Health Nonprofit's Employees
Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4 weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious trauma in Fronltine Service staff.
Primary Aim B. To determine if staff will continue to listen to guided imagery after the first 4 weeks of the study is over.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the change in stress levels of employees who listen to prerecorded guided imagery to employees who take breaks, and to determine if employees are likely to adopt prerecorded guided imagery as a self-care tool.
Participants will be randomly assigned to either the guided imagery group or the control group. Members of the control group will be asked to take a 10 minute break 3 times per week for 4 weeks. Members of the guided imagery group will be asked to listen to one prerecorded guided imagery track 3 times per week for 4 weeks. All participants will fill out questionnaires before and after the 4 week period. All participants will fill out a short form before and after listening to each guided imagery, or before and after taking each break.
Phase 2: After phase 1 is complete, all participants will have the option to participate in phase 2 of the study. During phase 2, participants will receive a calendar and put a mark on every day that they listen to a guided imagery track. At the end of 4 weeks, participants will turn in the calendar.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44114
- FrontLine Service
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Staff of a nonprofit who work a minimum of three shifts per week
- Willing and able to use about 8-15 minutes of their lunch hours three times per week for for four weeks for the study
Exclusion Criteria:
- Staff members will be excluded from the study if they currently listen to guided imagery
- Those currently experiencing drug or alcohol abuse, suicidal ideation, or other serious mental health issue while not under the care of a trained mental health professional will also be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 10 minute break
Participants asked to take a 10 minute break as usual 3 times per week for 4 weeks
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|
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Experimental: Guided Imagery
Participants listen to one of 6 pre-recorded guided imagery tracks 3 times per week for 4 weeks
|
Guided imagery is a stress management technique that uses verbal suggestion and descriptive language to guide the listener into imagining sensations and visualizing images in the mind in order to bring about a desired physical response, such as reduction in anxiety, stress, or pain.
The guided imagery tracks chosen for the study were chosen because their goal is relaxation and stress relief, and their length is under 15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety as Measured by the State Anxiety Short Form
Time Frame: 4 weeks
|
Participants in the experimental group will fill out the State Anxiety Short Form, a 6-item questionnaire before and after listening to guided imagery. Participants in the control group will fill out the same measure before and after taking a break. This will be done 3 times per week for a duration of 4 weeks. |
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol
Time Frame: 4 weeks
|
Participants in both the control and experimental groups will complete the ProQol, a 30-item questionnaire, before and after the 4-week intervention period.
|
4 weeks
|
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Perceived Stress as measured by the Perceived Stress Scale
Time Frame: 4 weeks
|
Participants in the experimental and control groups will complete the Perceived Stress Scale, a self-report, 10-item questionnaire, before and after the 4-week intervention period.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ashwini Sehgal, MD, Case Western Reserve University, MetroHealth Medical Center
- Principal Investigator: Kimberly A Juhas, MA, FrontLine Service
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD002265
- IRB-2014-743 (Other Identifier: Case Western Reserve University IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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