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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Intervention | Experimental | Engaging in self-guided breathing sessions to improve brain circulation and mental well-being. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Breathing | Behavioral | 15, 30, or 36 minute structured breathing sessions based on personal skill level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the physiological effects of the breathing-based intervention | As an exploratory objective, the study will assess the physiological effects of the breathing-based intervention on cerebral oxygenation and local tissue hemodynamics, utilizing functional near-infrared spectroscopy (fNIRS) data performed pre-and-post intervention. | Enrollment to end of intervention at 4 months. Additional assessments during data analysis period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle Boos | Contact | 715-464-8173 | boos.danielle@mayo.edu | |
| Paul Min, PhD | Contact | 507-255-2814 | min.paul@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pravesh Sharma, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System-Albert Lea | Active, not recruiting | Albert Lea | Minnesota | 56007 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41760153 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012120 | Respiration Disorders |
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| 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. | 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). | Enrollment to end of study participation at 4 months. |
| Enrollment to end of treatment at 4 months. |
| Assess the psychological effects of the breathing-based intervention | The psychological effects and outcomes will be assessed, using questionnaires completed at specific timepoints throughout the study. Questionnaires to include General Health Questionnaire (GHQ), Copenhagen Burnout Inventory (CBI), Generalized Anxiety Disorder scale (GAD), Perceived Stress Scale (PSS), Brief Resilience Scale (BRS). | Enrollment to end of intervention at 4 months. Additional assessments during data analysis period |
| Assess feasibility of collecting physiological and psychological data | This exploratory analysis is intended to assess the feasibility of collecting physiological and psychological data from participants, as reported by study staff who are assigned to collect this data. | Enrollment to end of study participation at 4 months. |
| Assess gathered data to apply to future research | This exploratory analysis will examine study data to identify preliminary trends that can inform the design and power calculations of future definitive trials. | Data analysis period after data collection is complete |
| Mayo Clinic Health System-Mankato |
| Active, not recruiting |
| Mankato |
| Minnesota |
| 56001 |
| United States |
| Mayo Clinic Health System-Eau Claire Clinic | Recruiting | Eau Claire | Wisconsin | 54703 | United States |
|
| Mayo Clinic Health System-La Crosse | Active, not recruiting | La Crosse | Wisconsin | 54601 | United States |
| D012140 |
| Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |