NCT03844308

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

February 13, 2019

Last Update Submit

February 1, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (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

Study Arms (2)

Group 1

EXPERIMENTAL

Participants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1.

Behavioral: Isha Kriya Meditation

Group 2

ACTIVE COMPARATOR

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

Interventions

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.

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Perioperative healthcare provider

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Burnout, ProfessionalOccupational StressAffective Symptoms

Condition Hierarchy (Ancestors)

Occupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Balachundhar Subramaniam, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 18, 2019

Study Start

January 15, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations