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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03844308
Other study ID # 2018P000387
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date October 31, 2020

Study information

Verified date February 2021
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in burnout levels among perioperative healthcare providers 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
Primary 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) From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Primary Changes in mood disturbances among perioperative healthcare providers 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 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). From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
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