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Wellness Tool in Anesthesia Providers

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ClinicalTrials.gov Identifier: NCT03844308
Recruitment Status : Completed
First Posted : February 18, 2019
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Brief Summary:
This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.

Condition or disease Intervention/treatment Phase
Burnout, Professional Occupational Stress Affective Symptoms Behavioral: Isha Kriya Meditation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Guided Meditation as a Wellness Tool in Anesthesia Providers
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: Group 1
Participants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1.
Behavioral: Isha Kriya Meditation
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.

Active Comparator: Group 2
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)
Behavioral: Isha Kriya Meditation
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 Measures :
  1. Changes in burnout levels among perioperative healthcare providers [ Time Frame: From baseline to six weeks for group1 and baseline to 12 weeks for group 2 ]
    Changes in burnout level due to meditation will be measured by Maslach Burnout Inventory (MBI)

  2. Changes in stress levels among perioperative healthcare providers [ Time Frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2 ]
    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)

  3. Changes in mood disturbances among perioperative healthcare providers [ Time Frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2 ]
    Changes in mood disturbances due to meditation will be measured by profile of mood survey (POMS)


Secondary Outcome Measures :
  1. Adherence to implementing a meditation program among healthcare providers. [ Time Frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2 ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844308


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Balachundhar Subramaniam, MD, MPH Beth Israel Deaconess Medical Center
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Responsible Party: Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03844308    
Other Study ID Numbers: 2018P000387
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burnout, Professional
Occupational Stress
Affective Symptoms
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Diseases