Burnout, Healthcare WorkersNCT07218458
A Study Of Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals
A study testing Structured Breathing in people with Burnout, Healthcare Workers and Breathing Exercises, run by Mayo Clinic at 4 sites in United States.
Trial summary
The purpose of this study is to assess the immediate and long-term effects of structured breathing on clinical symptoms related to mental health including anxiety, depression, perceived stress, and sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Healthcare Workers, Breathing Exercises
- What is being tested?
- Structured Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthcare professionals at the above-mentioned 4 MCHS sites (Eau Claire, La Crosse, Mankato, Albert Lea).
- Must score ≥40 on Copenhagen Burnout Inventory Q1-6.
- Participants must be physically fit enough to perform light exercise.
- Participants should read and understand English well enough to consent, complete measures, and follow instructions.
- Participants must have access to a smartphone or tablet.
Who cannot join
- Active primary psychotic disorder or substance use disorder (except nicotine dependence) within the past year.
- Severe or unstable medical condition that could interfere with participation or data collection.
- Active neurological condition (including seizure disorder, traumatic brain injury, or stroke) that could affect cognitive functioning or brain imaging results.
- Chronic lung disease (e.g., COPD, cystic fibrosis) or aneurysm.
- Current pregnancy or planning to become pregnant during the study period
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 1 recruiting
- Active, not recruiting
Mayo Clinic Health System-Albert Lea
Albert Lea, Minnesota, 56007
- Recruiting
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54703
Danielle Boos, 715-464-8173, boos.danielle@mayo.edu
Pravesh Sharma, MD, sharma.pravesh@mayo.edu
- Active, not recruiting
Mayo Clinic Health System-La Crosse
La Crosse, Wisconsin, 54601
- Active, not recruiting
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
About this study
Official title: Enhancing Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals (Breathing Study-Burnout)
The purpose of this study is to assess the immediate and long-term effects of structured breathing on clinical symptoms related to mental health including anxiety, depression, perceived stress, and sleep quality.
- Conditions
- Burnout, Healthcare Workers, Breathing Exercises
- Being tested
- Structured Breathing
- Keywords
- burnout, breathing
- Medical subject headings
- Burnout, Psychological, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured BreathingBehavioural
15, 30, or 36 minute structured breathing sessions based on personal skill level.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Intervention | Experimental | Engaging in self-guided breathing sessions to improve brain circulation and mental well-being. Receives: Behavioral: Structured Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess feasibility of the structured breathing-based intervention among healthcare professionals via ease of recruitment
This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals via ease of recruitment reported by study staff.
Measured: Enrollment to end of study participation at 4 months.
Assess feasibility of the structured breathing-based intervention among healthcare professionals via retention statistics
This outcome measure will assess the feasibility of the structured breathing-based intervention among healthcare professionals by examining retention rates throughout study duration.
Measured: Enrollment to end of study participation at 4 months
Assess feasibility of the structured breathing-based intervention among healthcare professionals via mobile app engagement metrics
This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals by analyzing app usage metrics from participants.
Measured: Enrollment to end of study participation at 4 months
Assess feasibility of structured breathing-based intervention among healthcare professionals via Feasibility of Intervention Measure
To assess the feasibility of a structured breathing intervention among healthcare professionals using Feasibility of Intervention Measure (FIM).
Feasibility of Intervention Measure is a four-item measure of implementation feasibility with scores ranging from 1-5, with higher scores indicating greater feasibility.
Measured: Enrollment to end of study participation at 4 months
Assess appropriateness of structured breathing-based intervention among healthcare professionals
To assess the appropriateness of a structured breathing intervention among healthcare professionals using Intervention Appropriateness Measure (IAM).
Intervention Appropriateness Measure is a four-item measure with a scale of responses from 1-5, with higher scores indicating greater appropriateness.
Measured: Enrollment to end of study participation at 4 months
Assess acceptability of structured breathing-based intervention among healthcare professionals
To assess the acceptability of a structured breathing intervention among healthcare professionals utilizing the Acceptability of Intervention Measure (AIM).
Acceptability of Intervention Measure is a four-item measure with responses from 1-5, with higher scores equating to greater acceptability.
Measured: From enrollment to the end of study participation at 4 months
Assess participant satisfaction related to breathing-based intervention
Participant satisfaction will be assessed through a mixed-methods approach combining quantitative surveys (exit survey) and qualitative participant interviews (4 month in-person visit/interview).
Measured: Enrollment to end of study participation at 4 months.
Secondary outcomes (1)
Evaluate intervention adherence, usability, and engagement metrics via mobile application
To evaluate the breathing intervention adherence, usability, and engagement metrics collected through the mobile application platform. These data will be used to identify barriers and facilitators to digital engagement, assess usability, and inform refinements to the intervention's delivery and technological infrastructure for future large-scale trials.
Measured: Enrollment to end of treatment at 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start27 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burnout, Healthcare WorkersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pravesh Sharma, Mayo Clinic
- Investigators
- Pravesh Sharma, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218458
- Sponsor's protocol ID
- 25-009320
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma P, Osman R, Nycklemoe M, Boos DM, Murphy CM, Flock C, Jacobson DN, Lim S, Nation JL, Wilson MA, Schuldt K, Min PH. Evaluation of a structured breathing-based intervention to reduce burnout and enhance mental well-being among healthcare professionals in community-based practice settings: study protocol for a single-arm pilot feasibility trial. BMJ Open. 2026 Feb 27;16(2):e113105. doi: 10.1136/bmjopen-2025-113105.
PubMed 41760153
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Resilience And Mental Well-Being Through Breathing Practice For Clinical Care Professionals (Breathing Study-Burnout)
- ClinicalTrials.gov ID
- NCT07218458
- Acronym / sponsor ID
- 25-009320
- Conditions
- Burnout, Healthcare Workers, Breathing Exercises
- Keywords
- burnout, breathing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Oct 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 purpose of this study is to assess the immediate and long-term effects of structured breathing on clinical symptoms related to mental health including anxiety, depression, perceived stress, and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathing Intervention | Experimental | Behavioral: Structured BreathingEngaging in self-guided breathing sessions to improve brain circulation and mental well-being. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be healthcare professionals at the above-mentioned 4 MCHS sites (Eau Claire, La Crosse, Mankato, Albert Lea).
- Must score ≥40 on Copenhagen Burnout Inventory Q1-6.
- Participants must be physically fit enough to perform light exercise.
- Participants should read and understand English well enough to consent, complete measures, and follow instructions.
- Participants must have access to a smartphone or tablet.
Key exclusion criteria (5 listed)
- Active primary psychotic disorder or substance use disorder (except nicotine dependence) within the past year.
- Severe or unstable medical condition that could interfere with participation or data collection.
- Active neurological condition (including seizure disorder, traumatic brain injury, or stroke) that could affect cognitive functioning or brain imaging results.
- Chronic lung disease (e.g., COPD, cystic fibrosis) or aneurysm.
- Current pregnancy or planning to become pregnant during the study period
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 |
|---|---|---|
| Structured Breathing15, 30, or 36 minute structured breathing sessions based on personal skill level. | Behavioural | Breathing Intervention |
Primary outcome
Assess feasibility of the structured breathing-based intervention among healthcare professionals via ease of recruitment
Time frame: Enrollment to end of study participation at 4 months.
This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals via ease of recruitment reported by study staff.
Assess feasibility of the structured breathing-based intervention among healthcare professionals via retention statistics
Time frame: Enrollment to end of study participation at 4 months
This outcome measure will assess the feasibility of the structured breathing-based intervention among healthcare professionals by examining retention rates throughout study duration.
Assess feasibility of the structured breathing-based intervention among healthcare professionals via mobile app engagement metrics
Time frame: Enrollment to end of study participation at 4 months
This outcome measure will assess whether the structured breathing-based intervention is feasible among healthcare professionals by analyzing app usage metrics from participants.
Assess feasibility of structured breathing-based intervention among healthcare professionals via Feasibility of Intervention Measure
Time frame: Enrollment to end of study participation at 4 months
To assess the feasibility of a structured breathing intervention among healthcare professionals using Feasibility of Intervention Measure (FIM). Feasibility of Intervention Measure is a four-item measure of implementation feasibility with scores ranging from 1-5, with higher scores indicating greater feasibility.
Assess appropriateness of structured breathing-based intervention among healthcare professionals
Time frame: Enrollment to end of study participation at 4 months
To assess the appropriateness of a structured breathing intervention among healthcare professionals using Intervention Appropriateness Measure (IAM). Intervention Appropriateness Measure is a four-item measure with a scale of responses from 1-5, with higher scores indicating greater appropriateness.
Assess acceptability of structured breathing-based intervention among healthcare professionals
Time frame: From enrollment to the end of study participation at 4 months
To assess the acceptability of a structured breathing intervention among healthcare professionals utilizing the Acceptability of Intervention Measure (AIM). Acceptability of Intervention Measure is a four-item measure with responses from 1-5, with higher scores equating to greater acceptability.
Assess participant satisfaction related to breathing-based intervention
Time frame: Enrollment to end of study participation at 4 months.
Participant satisfaction will be assessed through a mixed-methods approach combining quantitative surveys (exit survey) and qualitative participant interviews (4 month in-person visit/interview).
1 secondary outcome
Evaluate intervention adherence, usability, and engagement metrics via mobile application
Time frame: Enrollment to end of treatment at 4 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 41760153Sharma P, Osman R, Nycklemoe M, Boos DM, Murphy CM, Flock C, Jacobson DN, Lim S, Nation JL, Wilson MA, Schuldt K, Min PH. Evaluation of a structured breathing-based intervention to reduce burnout and enhance mental well-being among healthcare professionals in community-based practice settings: study protocol for a single-arm pilot feasibility trial. BMJ Open. 2026 Feb 27;16(2):e113105. doi: 10.1136/bmjopen-2025-113105.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Pravesh Sharma, MD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Breathing in people with Burnout, Healthcare Workers and Breathing Exercises, run by Mayo Clinic at 4 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Boos (715-464-8173, boos.danielle@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess feasibility of the structured breathing-based intervention among healthcare professionals via ease of recruitment (time frame: Enrollment to end of study participation at 4 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07218458, which also lists 1 linked publication.
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 Nov 2026.