Back to resultsWellness Tool in Anesthesia Providers
Primary Purpose
Burnout, Professional, Occupational Stress, Affective Symptoms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isha Kriya Meditation
Sponsored by
About this trial
This is an interventional prevention trial for Burnout, Professional
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Perioperative healthcare provider
Exclusion Criteria:
- Low English proficiency
- Currently enrolled in another interventional study that could impact the primary outcome, as determined by the Principal Investigator
- Not currently residing in the United States
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Participants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1.
Participants will be asked to refrain from meditating for the first 6 weeks (phase 1) and then asked to complete Isha Kriya meditation for another 6 weeks (phase 2)
Outcomes
Primary Outcome Measures
Changes in burnout levels among perioperative healthcare providers
Changes in burnout level due to meditation will be measured by Maslach Burnout Inventory (MBI)
Changes in stress levels among perioperative healthcare providers
Changes in stress levels due to meditation will be measured by perceived stress scale (PSS; Scores can range from 0 to 40, with higher scores indicating higher perceived stress)
Changes in mood disturbances among perioperative healthcare providers
Changes in mood disturbances due to meditation will be measured by profile of mood survey (POMS)
Secondary Outcome Measures
Adherence to implementing a meditation program among healthcare providers.
In this descriptive study, evaluation of feasibility will include adherence to meditation intervention (the proportion of completed meditation sessions out of the total required per protocol).
Full Information
NCT ID
NCT03844308
First Posted
February 13, 2019
Last Updated
February 1, 2021
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03844308
Brief Title
Wellness Tool in Anesthesia Providers
Official Title
Guided Meditation as a Wellness Tool in Anesthesia Providers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.
Detailed Description
In this study, investigators will evaluate the effect of Isha Kriya meditation on stress and burnout among perioperative healthcare providers. To do this, investigators will randomize healthy participants to one of two groups: one who will meditate twice daily for six weeks (group 1), and the other who will not meditate for first six weeks and then meditate for another six weeks (group 2). Investigators will then evaluate stress and burnout using validated electronic instruments at baseline and at six weeks for group 1 and at baseline, six weeks, and 12 weeks for group 2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Occupational Stress, Affective Symptoms
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
Masking
Participant
Allocation
Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Participants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Participants will be asked to refrain from meditating for the first 6 weeks (phase 1) and then asked to complete Isha Kriya meditation for another 6 weeks (phase 2)
Intervention Type
Behavioral
Intervention Name(s)
Isha Kriya Meditation
Intervention Description
Isha Kriya (IK) meditation is a meditation that can be learned quickly and requires approximately 12 minutes, twice a day practice. This regimen was chosen because it excels in simplicity and is a great way to introduce meditation to beginners. It does not incorporate a spiritual or religious focus. It was developed by the Isha Institute of Inner Sciences, a nonprofit foundation located at McMinnville, Tennessee.
Primary Outcome Measure Information:
Title
Changes in burnout levels among perioperative healthcare providers
Description
Changes in burnout level due to meditation will be measured by Maslach Burnout Inventory (MBI)
Time Frame
From baseline to six weeks for group1 and baseline to 12 weeks for group 2
Title
Changes in stress levels among perioperative healthcare providers
Description
Changes in stress levels due to meditation will be measured by perceived stress scale (PSS; Scores can range from 0 to 40, with higher scores indicating higher perceived stress)
Time Frame
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Title
Changes in mood disturbances among perioperative healthcare providers
Description
Changes in mood disturbances due to meditation will be measured by profile of mood survey (POMS)
Time Frame
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Secondary Outcome Measure Information:
Title
Adherence to implementing a meditation program among healthcare providers.
Description
In this descriptive study, evaluation of feasibility will include adherence to meditation intervention (the proportion of completed meditation sessions out of the total required per protocol).
Time Frame
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Perioperative healthcare provider
Exclusion Criteria:
Low English proficiency
Currently enrolled in another interventional study that could impact the primary outcome, as determined by the Principal Investigator
Not currently residing in the United States
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balachundhar Subramaniam, MD, MPH
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Wellness Tool in Anesthesia Providers
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