StressNCT04858815
Using Yogic Breathing to Reduce Stress in Anesthesia Personnel As Measured by Hair Cortisol
A study testing yogic breathing in people with Stress and Burnout, Professional, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Professional
- What is being tested?
- yogic breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 7 Jul 2022
- 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
- All clinical members of the MUSC anesthesia department (Attending physicians, resident physicians, and CRNAs)
Who cannot join
- Pregnancy (or anticipated pregnancy)
- chronic steroid use
- inadequate hair length for testing (less than 3cm at the back of the head)
- residents with anticipated graduation within the next one year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool that can be utilized by healthcare workers to combat burnout and decrease perceived levels of stress. Our aim is to understand and measure both subjectively and objectively the effects of long-term yogic breathing on stress levels in anesthesia personnel. This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. The primary aim of the trial is to estimate the correlation between participant stress with average duration of yogic breathing over time. Secondarily the feasibility of implementing yogic breathing practices among anesthesiology practitioners will be evaluated. Feasibility measures will include recruitment rates, retention at 1year follow-up, and adherence to the yogic breathing program at 12 months.
- Conditions
- Stress, Burnout, Professional
- Being tested
- yogic breathing
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogic breathingBehavioural
participation in yogic breathing
| Study group | Role | What they receive |
|---|---|---|
| Administration of yogic breathing program | Experimental | This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a self-administered yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. Receives: Behavioral: yogic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of participant stress with average duration of yogic breathing over time
The study will estimate the efficacy of self-administered yogic breathing on participant stress over time using (a) cortisol levels measured in hair and (b) using validated survey instruments estimated as the change in stress from baseline to 12 months. The primary measure of efficacy is correlation between cortisol/stress levels with average weekly duration of yogic breathing in minutes.
Measured: baseline & 12 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start26 Apr 2021
- Primary completion7 Jun 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm longitudinal trial
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grayce Davis, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858815
- Sponsor's protocol ID
- Pro00105235
- Status last verified
- Oct 2024
- First submitted
- 21 Apr 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Yogic Breathing to Reduce Stress in Anesthesia Personnel As Measured by Hair Cortisol
- ClinicalTrials.gov ID
- NCT04858815
- Acronym / sponsor ID
- Pro00105235
- Conditions
- Stress, Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 26 Apr 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.
Mind body exercises have long been used as a way for individuals to reduce stress and improve well-being. Recent studies indicate that yogic breathing (YB, also known as pranayama) could potentially impact both the mind and body by engaging both the physiological and neural elements and can thus be a specific tool that can be utilized by healthcare workers to combat burnout and decrease perceived levels of stress. Our aim is to understand and measure both subjectively and objectively the effects of long-term yogic breathing on stress levels in anesthesia personnel. This will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. The primary aim of the trial is to estimate the correlation between participant stress with average duration of yogic breathing over time. Secondarily the feasibility of implementing yogic breathing practices among anesthesiology practitioners will be evaluated. Feasibility measures will include recruitment rates, retention at 1year follow-up, and adherence to the yogic breathing program at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm longitudinal trial
| Arm | Type | Receives |
|---|---|---|
| Administration of yogic breathing program | Experimental | Behavioral: yogic breathingThis will be a single arm longitudinal trial designed to evaluate the feasibility and estimate the efficacy of implementing a self-administered yogic breathing program for stress reduction among anesthesiology practitioners at one academic medical center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All clinical members of the MUSC anesthesia department (Attending physicians, resident physicians, and CRNAs)
Key exclusion criteria (4 listed)
- Pregnancy (or anticipated pregnancy)
- chronic steroid use
- inadequate hair length for testing (less than 3cm at the back of the head)
- residents with anticipated graduation within the next one year.
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 |
|---|---|---|
| yogic breathingparticipation in yogic breathing | Behavioural | Administration of yogic breathing program |
Primary outcome
Correlation of participant stress with average duration of yogic breathing over time
Time frame: baseline & 12 month visit
The study will estimate the efficacy of self-administered yogic breathing on participant stress over time using (a) cortisol levels measured in hair and (b) using validated survey instruments estimated as the change in stress from baseline to 12 months. The primary measure of efficacy is correlation between cortisol/stress levels with average weekly duration of yogic breathing in minutes.
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 24 Oct 2024.
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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.
Grayce Davis, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yogic breathing in people with Stress and Burnout, Professional, run by Medical University of South Carolina 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 1 inclusion and 4 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 24 Oct 2024. 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?
Correlation of participant stress with average duration of yogic breathing over time (time frame: baseline & 12 month visit). 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 24 Oct 2024.