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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02191345
Other study ID # MD002265
Secondary ID IRB-2014-743
Status Completed
Phase N/A
First received July 14, 2014
Last updated February 18, 2017
Start date July 2014
Est. completion date November 2014

Study information

Verified date February 2017
Source FrontLine Service
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Guided Imagery
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.

Locations

Country Name City State
United States FrontLine Service Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
FrontLine Service National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary State Anxiety as Measured by the State Anxiety Short Form 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 Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol 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
Secondary Perceived Stress as measured by the Perceived Stress Scale 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
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