NCT02191345

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

July 14, 2014

Last Update Submit

February 18, 2017

Conditions

Focus of StudyStress

Keywords

guided imageryburnoutcompassion fatiguestate anxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Compassion Fatigue, Compassion Satisfaction, and Burnout, as measured by the ProQol

    4 weeks

  • Perceived Stress as measured by the Perceived Stress Scale

    4 weeks

Study Arms (2)

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

Behavioral: Guided Imagery

Interventions

Guided ImageryBEHAVIORAL

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.

Guided Imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FrontLine Service

Cleveland, Ohio, 44114, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalCompassion FatigueAnxiety Disorders

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsOccupational StressMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ashwini Sehgal, MD

    Case Western Reserve University, MetroHealth Medical Center

    STUDY DIRECTOR

  • Kimberly A Juhas, MA

    FrontLine Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Community Research Scholar

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 16, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)