BurnoutNCT04968795
Heartfulness Meditation and Corporate Burnout
An observational study of Burnout and Meditation, run by Resolution Blue Labs Inc at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Meditation, Stress
- What is being tested?
- Heartfulness Meditation
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults above 18 years of age willing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Resolution Blue Labs Inc
Toronto, Ontario, M1T1P2
Administrator Resolution Blue Labs Inc., admin@resolutionbluelabs.com
About this study
Official title: Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements
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.
- Conditions
- Burnout, Meditation, Stress, Heartfulness
- Being tested
- Heartfulness Meditation
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartfulness MeditationOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Heartfulness Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Burnout Scores
Assess the difference in burnout scores between both groups at week 0 and week 4.
Measured: Week 0 & Week 4
Secondary outcomes (1)
Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory.
Assess the difference in specific symptoms scores between both groups at week 0 and week 4.
Measured: Week 0 & Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 May 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resolution Blue Labs Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Heartfulness Institute
- Responsible party
- Sponsor
- Investigators
- Andy Kumar, MD/PhD Candidate, Principal investigator, Resolution Blue Labs IncAravindhan Ravindhran, MD, Principal investigator, Resolution Blue Labs IncArth Patel, MD Candidate, Principal investigator, Resolution Blue Labs Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968795
- Sponsor's protocol ID
- RBL-X Wellness_01
- Status last verified
- Sep 2021
- First submitted
- 9 Jul 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Heartfulness Corporate Wellness Program on Burnout Inventory Measurements
- ClinicalTrials.gov ID
- NCT04968795
- Acronym / sponsor ID
- RBL-X Wellness_01
- Conditions
- Burnout, Meditation, Stress, Heartfulness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Resolution Blue Labs IncIndustry (pharma, biotech, devices)
- Collaborators
- Heartfulness Institute
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Participate in filling the questionnaire but NOT the meditation/wellness session (control). |
| Wellness Group | – | Other: Heartfulness MeditationParticipate in filling the questionnaire and the meditation/wellness session |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults above 18 years of age willing to participate in the study.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartfulness MeditationA 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. | Other | Wellness Group |
Primary outcome
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.
1 secondary outcome
Changes in in scores measuring symptoms of emotional exhaustion, depersonalization, and personal accomplishment, using the Maslach Burnout Inventory.
Time frame: Week 0 & Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Kumar, MD/PhD Candidate principal investigator
Resolution Blue Labs Inc
Aravindhan Ravindhran, MD principal investigator
Resolution Blue Labs Inc
Arth Patel, MD Candidate principal investigator
Resolution Blue Labs Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burnout and Meditation, run by Resolution Blue Labs Inc at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ankit Bahl (204-295-0298, Ankit@resolutionbluelabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Burnout Scores (time frame: Week 0 & Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.