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出境医 / 临床实验 / 满心冥想和企业倦怠

满心冥想和企业倦怠

Study Description
Brief Summary:

The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees.

The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.


Condition or disease Intervention/treatment
Burnout Meditation Stress Heartfulness Other: Heartfulness Meditation

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Control
Participate in filling the questionnaire but NOT the meditation/wellness session (control).
Wellness Group
Participate in filling the questionnaire and the meditation/wellness session
Other: Heartfulness Meditation
A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.

Outcome Measures
Primary Outcome Measures :
  1. Differences in Burnout Scores [ Time Frame: Week 0 & Week 4 ]
    Assess the difference in burnout scores between both groups at week 0 and week 4.


Secondary Outcome Measures :
  1. Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory. [ Time Frame: Week 0 & Week 4 ]
    Assess the difference in specific symptoms scores between both groups at week 0 and week 4.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is reflective of the general population, who work in large corporations and have self-identified as having moderate to high levels of stress.
Criteria

Inclusion Criteria:

  • Adults above 18 years of age willing to participate in the study.

Exclusion Criteria:

  • Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.
Contacts and Locations

Contacts
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Contact: Ankit Bahl 204-295-0298 Ankit@resolutionbluelabs.com
Contact: Swaraj Aravind 778-908-7839 Swaraj@resolutionbluelabs.com

Locations
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Canada, Ontario
Resolution Blue Labs Inc Recruiting
Toronto, Ontario, Canada, M1T1P2
Contact: Administrator Resolution Blue Labs Inc.       admin@resolutionbluelabs.com   
Sponsors and Collaborators
Resolution Blue Labs Inc
Heartfulness Institute
Investigators
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Principal Investigator: Andy Kumar, MD/PhD Candidate Resolution Blue Labs Inc
Principal Investigator: Aravindhan Ravindhran, MD Resolution Blue Labs Inc
Principal Investigator: Arth Patel, MD Candidate Resolution Blue Labs Inc
Tracking Information
First Submitted Date July 9, 2021
First Posted Date July 20, 2021
Last Update Posted Date October 8, 2021
Actual Study Start Date May 1, 2021
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2021)
Differences in Burnout Scores [ Time Frame: Week 0 & Week 4 ]
Assess the difference in burnout scores between both groups at week 0 and week 4.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2021)
Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory. [ Time Frame: Week 0 & Week 4 ]
Assess the difference in specific symptoms scores between both groups at week 0 and week 4.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Heartfulness Meditation and Corporate Burnout
Official Title Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements
Brief Summary

The purpose of this study is to evaluate the effect of a 4-week heart-based meditation practice wellness workshop on burnout and emotional wellness in corporate employees. Corporate employees can be defined as individuals who work in large institutions with greater than 300 employees.

The specific aim of this study is to assess changes in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment using the Maslach Burnout Index. We hypothesize that the meditation wellness practice will be associated with reduction in burnout for those who take part in the meditation program in comparison to the participants who did not meditate and participate in the wellness program.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The study population is reflective of the general population, who work in large corporations and have self-identified as having moderate to high levels of stress.
Condition
  • Burnout
  • Meditation
  • Stress
  • Heartfulness
Intervention Other: Heartfulness Meditation
A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.
Study Groups/Cohorts
  • Control
    Participate in filling the questionnaire but NOT the meditation/wellness session (control).
  • Wellness Group
    Participate in filling the questionnaire and the meditation/wellness session
    Intervention: Other: Heartfulness Meditation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 9, 2021)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults above 18 years of age willing to participate in the study.

Exclusion Criteria:

  • Individuals less than 18 years of age, active suicidal ideation, current or past diagnoses of serious psychotic disorders- schizophrenia, personality disorders and post-traumatic stress disorder.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ankit Bahl 204-295-0298 Ankit@resolutionbluelabs.com
Contact: Swaraj Aravind 778-908-7839 Swaraj@resolutionbluelabs.com
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04968795
Other Study ID Numbers RBL-X Wellness_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Resolution Blue Labs Inc
Study Sponsor Resolution Blue Labs Inc
Collaborators Heartfulness Institute
Investigators
Principal Investigator: Andy Kumar, MD/PhD Candidate Resolution Blue Labs Inc
Principal Investigator: Aravindhan Ravindhran, MD Resolution Blue Labs Inc
Principal Investigator: Arth Patel, MD Candidate Resolution Blue Labs Inc
PRS Account Resolution Blue Labs Inc
Verification Date September 2021