Wellness Tool in Anesthesia Providers

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03844308
• Collaborator: (none)
• Enrollment: 94
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.5
• Patients Per Site Per Month: 4.4

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• 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.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: Jan 15, 2019
• Actual Primary Completion Date: Oct 31, 2020
• Actual Study Completion Date: Oct 31, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in burnout levels among perioperative healthcare providers [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 [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 [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. [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Balachundhar Subramaniam, MD, MPH, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03844308
• Other Study ID Numbers: 2018P000387
• First Posted: Feb 18, 2019
• Last Update Posted: Feb 2, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Burnout, Professional; Occupational Stress; Affective Symptoms

Study Results

No Results Posted as of Feb 2, 2021