NCT06779526

Brief Summary

The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would

  1. 1.decrease burnout
  2. 2.improve sleep and work engagement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 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

May 8, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 11, 2025

Last Update Submit

January 11, 2025

Conditions

Keywords

heartfulnessmeditationwork enagementsleepburnout

Outcome Measures

Primary Outcomes (1)

  • Sleep

    The Bergen Insomnia Scale (BIS) was measured prior to enrollment, at the four-week time point after the first half of the study, and at the end of the study period at 8 weeks for both the groups. The BIS contains six questions relating to sleep and tiredness, and it is scaled based on the number of days per week that participants are experiencing symptoms. 0 means no days during the course of a week, and 7 indicates every day of the week.

    From intervention to end of intervention at 4 weeks for each group

Secondary Outcomes (2)

  • Work engagement

    From intervention to end of intervention at 4 weeks for each group

  • Burnout

    From intervention to end of intervention at 4 weeks for each group

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Comprised of receiving an orientation session regarding the study, attending at least once weekly didactic sessions on Zoom and participating in morning and evening meditation for ten to fifteen minutes daily. A weekly, live online session for 4 weeks consists of 30 minutes of didactics, comprising of a 10 minute introductory talk on a module of meditation, followed by 20 minutes of guided meditation. Participants provided with materials such as guided audio clips to independently follow heartfulness practices (meditation, rejuvenation, and bed-time relaxation) for 20 minutes each day for 4 weeks: 10 minutes Heartfulness meditation in the morning and 10 minutes in the evening before sleeping Email reminders were sent weekly containing audio recordings for guided meditation sessions. All study activities were virtual.

Other: Heartfulness Meditation

Control arm

NO INTERVENTION

The control group would not be undergoing any intervention.

Interventions

Receiving an orientation session regarding the study, attending once weekly didactic sessions on Zoom for Heartfulness Meditation, and participating in morning and evening meditation for ten to fifteen minutes daily either by themselves or along with the trainer.

Intervention Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age above 18 and willing to participate
  • Able to understand the English language as the instructions were in English

You may not qualify if:

  • Not able to understand English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WellSpan Health

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The demographic data that is collected from the participants will never be available for the PI/co-investigators to see. It will be secure in a password-protected file, and at the end of the study, the data will be de-identified prior to data analysis. Any information that will be collected from participants will be done so during the screening/intake process. If the participant decides to leave the study, the work email address along with all the information will be deleted from the file. Steps taken to make the subjects feel at ease with the process include informing them during intake about all the specific steps involved ahead of time, so they know what to expect. With regards to the didactic sessions, it will be conducted in Webinar mode, which will protect the names and privacy of the participants from one another. After that, participants will not know the other people who are participating. The repeat questionnaires that are sent to the participants will be directly
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Hospitalist

Study Record Dates

First Submitted

January 11, 2025

First Posted

January 16, 2025

Study Start

May 8, 2024

Primary Completion

August 8, 2024

Study Completion

August 31, 2024

Last Updated

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations