SleepWEBSNCT06779526
Effect of Four-Week Wellness Program on Work Engagement Burnout and Sleep in a Healthcare Organization (WEBS)
A study testing Heartfulness Meditation in people with Sleep and Burnout, run by WellSpan Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would 1. decrease burnout 2. improve sleep and work engagement. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Burnout, Work Engagement
- What is being tested?
- Heartfulness Meditation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 31 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age above 18 and willing to participate
- Able to understand the English language as the instructions were in English
Who cannot join
- Not able to understand English language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Four-Week Wellness Program on Sleep and Work Engagement in a Healthcare Organization
The goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would
- decrease burnout
- improve sleep and work engagement.
Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention
Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.
Read the detailed description
The study is an 8-week single-center prospective, randomized, crossover study among healthcare workers in the WellSpan Health System. All participants were asked to answer two demographic questions and responses to the Utrecht Work Engagement Scale (UWES), and Bergen Insomnia Scale (BIS), two burnout questions were requested for a baseline. Participants were randomized to two groups. One of the groups would undergo the intervention first, which comprised 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. The duration of the intervention period was four weeks. During this time, the control group would not be undergoing any intervention. After four weeks, both groups completed the original questionnaire again followed by a 2 week washout period. This was followed by a crossover, allowing the second group to undergo the intervention for four weeks. After four weeks, the final survey was sent to all participants again.
- Conditions
- Sleep, Burnout, Work Engagement
- Being tested
- Heartfulness Meditation
- Keywords
- heartfulness, meditation, work enagement, sleep, burnout
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Heartfulness Meditation |
| Control arm | No intervention | The control group would not be undergoing any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From intervention to end of intervention at 4 weeks for each group
Secondary outcomes (2)
Work engagement
THE UWES scale, designed to study work engagement using three scales: vigor, dedication, and absorption was measured prior to the beginning of the study, 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 groups. The UWES questionnaire contains 9 questions, and participants are given a scale from 0 to 6, with 0 being never to 6 being always 10.
Measured: From intervention to end of intervention at 4 weeks for each group
Burnout
Two burnout questions were asked, 1. I feel burned out from my work 2. I have become more callous toward people since I took this job . The scale for answering these questions ranged from never to everyday. This was measured prior to the beginning of the study, 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 groups.
Measured: From intervention to end of intervention at 4 weeks for each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start8 May 2024
- Primary completion8 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Thimmapuram, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779526
- Sponsor's protocol ID
- [2126338-4]
- Acronym
- WEBS
- Status last verified
- Jan 2025
- First submitted
- 11 Jan 2025
- Last updated
- 16 Jan 2025
- 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 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Four-Week Wellness Program on Sleep and Work Engagement in a Healthcare Organization
- ClinicalTrials.gov ID
- NCT06779526
- Acronym / sponsor ID
- WEBS / [2126338-4]
- Conditions
- Sleep, Burnout, Work Engagement
- Keywords
- heartfulness, meditation, work enagement, sleep, burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 16 Jan 2025 (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 goal of this clinical trial is to learn if having a 4-week heartfulness meditation program in a healthcare organization would
- decrease burnout
- improve sleep and work engagement.
Researchers will compare : intervention group : participating in 4 weeks of Heartfulness Meditation with control group: receiving no intervention
Responses to the Utrecht Work Engagement Scale (UWES), Bergen Insomnia Scale (BIS) and two burnout questions will be compared between the study groups at the beginning and end of the intervention period.
Detailed description
The study is an 8-week single-center prospective, randomized, crossover study among healthcare workers in the WellSpan Health System. All participants were asked to answer two demographic questions and responses to the Utrecht Work Engagement Scale (UWES), and Bergen Insomnia Scale (BIS), two burnout questions were requested for a baseline. Participants were randomized to two groups. One of the groups would undergo the intervention first, which comprised 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. The duration of the intervention period was four weeks. During this time, the control group would not be undergoing any intervention. After four weeks, both groups completed the original questionnaire again followed by a 2 week washout period. This was followed by a crossover, allowing the second group to undergo the intervention for four weeks. After four weeks, the final survey was sent to all participants again.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Heartfulness MeditationComprised 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. |
| Control arm | No intervention | –The control group would not be undergoing any intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18 and willing to participate
- Able to understand the English language as the instructions were in English
Key exclusion criteria (1 listed)
- Not able to understand English language
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 MeditationReceiving 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. | Other | Intervention Arm |
Primary outcome
Sleep
Time frame: From intervention to end of intervention at 4 weeks for each group
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.
2 secondary outcomes
Work engagement
Time frame: From intervention to end of intervention at 4 weeks for each group
Burnout
Time frame: From intervention to end of intervention at 4 weeks for each group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartfulness Meditation in people with Sleep and Burnout, run by WellSpan Health at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 16 Jan 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep (time frame: From intervention to end of intervention at 4 weeks for each group). 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 16 Jan 2025.