Wellness Tool in Anesthesia Providers

February 1, 2021 updated by: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Guided Meditation as a Wellness Tool in Anesthesia Providers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline to six weeks for group1 and baseline to 12 weeks for group 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)
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
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)
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From baseline to six weeks for group 1 and baseline to 12 weeks for group 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P000387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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