Burnout, ProfessionalNCT03844308
Wellness Tool in Anesthesia Providers
A study testing Isha Kriya Meditation in people with Burnout, Professional and Occupational Stress, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Occupational Stress, Affective Symptoms
- What is being tested?
- Isha Kriya Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 31 Oct 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Perioperative healthcare provider
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Guided Meditation as a Wellness Tool in Anesthesia Providers
This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.
Read the detailed description
In this study, investigators will evaluate the effect of Isha Kriya meditation on stress and burnout among perioperative healthcare providers. To do this, investigators will randomize healthy participants to one of two groups: one who will meditate twice daily for six weeks (group 1), and the other who will not meditate for first six weeks and then meditate for another six weeks (group 2). Investigators will then evaluate stress and burnout using validated electronic instruments at baseline and at six weeks for group 1 and at baseline, six weeks, and 12 weeks for group 2.
- Being tested
- Isha Kriya Meditation
- Medical subject headings
- Burnout, Professional, Occupational Stress, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isha Kriya MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1. Receives: 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) Receives: Behavioral: Isha Kriya Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in burnout levels among perioperative healthcare providers
Changes in burnout level due to meditation will be measured by Maslach Burnout Inventory (MBI)
Measured: 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)
Measured: 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)
Measured: 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.
In this descriptive study, evaluation of feasibility will include adherence to meditation intervention (the proportion of completed meditation sessions out of the total required per protocol).
Measured: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start15 Jan 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844308
- Sponsor's protocol ID
- 2018P000387
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Meditation as a Wellness Tool in Anesthesia Providers
- ClinicalTrials.gov ID
- NCT03844308
- Acronym / sponsor ID
- 2018P000387
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 18 Feb 2019 (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.
This study will examine the effects of Isha Kriya meditation on stress and burnout among healthcare providers.
Detailed description
In this study, investigators will evaluate the effect of Isha Kriya meditation on stress and burnout among perioperative healthcare providers. To do this, investigators will randomize healthy participants to one of two groups: one who will meditate twice daily for six weeks (group 1), and the other who will not meditate for first six weeks and then meditate for another six weeks (group 2). Investigators will then evaluate stress and burnout using validated electronic instruments at baseline and at six weeks for group 1 and at baseline, six weeks, and 12 weeks for group 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a waitlisted controlled study where the control group will receive the intervention after the intervention arm completes the study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: Isha Kriya MeditationParticipants will be asked to complete Isha Kriya meditation twice daily for a total of six weeks in phase 1. |
| Group 2 | Active comparator | Behavioral: Isha Kriya MeditationParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Perioperative healthcare provider
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Isha Kriya MeditationIsha 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. | Behavioural | Group 1, Group 2 |
Primary outcome
Changes in burnout levels among perioperative healthcare providers
Time frame: From baseline to six weeks for group1 and baseline to 12 weeks for group 2
Changes in burnout level due to meditation will be measured by Maslach Burnout Inventory (MBI)
Changes in stress levels among perioperative healthcare providers
Time frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
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)
Changes in mood disturbances among perioperative healthcare providers
Time frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
Changes in mood disturbances due to meditation will be measured by profile of mood survey (POMS)
1 secondary outcome
Adherence to implementing a meditation program among healthcare providers.
Time frame: From baseline to six weeks for group 1 and baseline to 12 weeks for group 2
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 2 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Balachundhar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isha Kriya Meditation in people with Burnout, Professional and Occupational Stress, run by Beth Israel Deaconess Medical Center 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 3 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 2 Feb 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 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?
Changes in burnout levels among perioperative healthcare providers (time frame: From baseline to six weeks for group1 and baseline to 12 weeks for group 2). The study lists 3 primary outcomes in all. 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 2 Feb 2021.