Focus of StudyNCT02191345
The Effectiveness of Guided Imagery for a Nonprofit's Employees
A study testing Guided Imagery in people with Focus of Study and Stress, run by FrontLine Service at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Focus of Study, Stress
- What is being tested?
- Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Focus of Study, Stress
- Being tested
- Guided Imagery
- Keywords
- guided imagery, burnout, compassion fatigue, state anxiety
- Medical subject headings
- Burnout, Psychological, Compassion Fatigue, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 10 minute break | No intervention | Participants asked to take a 10 minute break as usual 3 times per week for 4 weeks |
| Guided Imagery | Experimental | Participants listen to one of 6 pre-recorded guided imagery tracks 3 times per week for 4 weeks Receives: Behavioral: Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of StudyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- FrontLine Service
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kimberly Juhas, FrontLine Service
- Investigators
- Ashwini Sehgal, MD, Study director, Case Western Reserve University, MetroHealth Medical CenterKimberly A Juhas, MA, Principal investigator, FrontLine Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191345
- Sponsor's protocol ID
- MD002265
- Other IDs
- IRB-2014-743
- Status last verified
- Feb 2017
- First submitted
- 14 Jul 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02191345
- Acronym / sponsor ID
- MD002265
- Conditions
- Focus of Study, Stress
- Keywords
- guided imagery, burnout, compassion fatigue, state anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- FrontLine ServiceUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10 minute break | No intervention | –Participants asked to take a 10 minute break as usual 3 times per week for 4 weeks |
| Guided Imagery | Experimental | Behavioral: Guided ImageryParticipants listen to one of 6 pre-recorded guided imagery tracks 3 times per week for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Guided ImageryGuided 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. | Behavioural | Guided Imagery |
Primary outcome
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.
2 secondary outcomes
Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol
Time frame: 4 weeks
Perceived Stress as measured by the Perceived Stress Scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Focus of Study
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
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.
Ashwini Sehgal, MD study director
Case Western Reserve University, MetroHealth Medical Center
Kimberly A Juhas, MA principal investigator
FrontLine Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Focus of Study and Stress, run by FrontLine Service 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 2 inclusion and 2 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 23 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State Anxiety as Measured by the State Anxiety Short Form (time frame: 4 weeks). 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 23 Feb 2017.