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

Abstract

Introduction

Burnout among healthcare professionals remains a critical public health issue linked to impaired cognition, emotional exhaustion and diminished clinical performance. Structured breathing practices have demonstrated promise in improving autonomic regulation and cerebral oxygenation, yet their feasibility, acceptability and implementation in real-world healthcare settings remain underexplored.

Objectives

This single-arm pilot feasibility trial aims to evaluate the feasibility, acceptability and implementation appropriateness of a structured breathing-based intervention for healthcare professionals across community-based Mayo Clinic Health System (MCHS) sites. Secondary objectives include assessing usability and engagement with the mobile breathing platform, while exploratory analyses will describe magnitude of variability and feasibility of collecting psychological and cerebral haemodynamic measures. This study will commence in November 2025 and is expected to be completed by June 2026.

Methods and analysis

A total of 40 clinicians (MD/DO/MBBS/PA) and nurses reporting moderate or greater burnout will be enrolled across four MCHS sites. Participants will complete a 4-month structured breathing programme delivered primarily online, supported by a mobile application for practice tracking. Assessments will occur at baseline, 2 months and 4 months, with functional near-infrared spectroscopy (fNIRS) measures of cerebral oxygenation collected at baseline and 4 months in a population subset. Primary outcomes include (1) recruitment yield, retention and adherence rates; (2) acceptability and participant satisfaction (survey and qualitative feedback); and (3) implementation appropriateness measured by the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM). Secondary outcomes include digital engagement and usability through mobile analytics and the System Usability Scale. Exploratory outcomes are psychological indicators (burnout, depression, anxiety, perceived stress, sleep, fatigue, professional fulfilment and resilience) and physiological endpoints (fNIRS). Analyses will be descriptive, summarising feasibility metrics with 95% CIs. Progression criteria (recruitment≥75%, retention≥80%, adherence≥70%, AIM/IAM/FIM≥4.0) will determine readiness for a definitive hybrid effectiveness–implementation trial.

Ethics and dissemination

The study is approved by the Mayo Clinic Institutional Review Board (IRB # 25-009320). All participants will provide informed consent. Study procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be securely stored in REDCap and disseminated through peer-reviewed publications and scientific conference

Trial registration number

NCT07218458.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Evaluates a structured breathing-based intervention using both subjective and objective indicators of feasibility, including recruitment, retention, adherence and implementation appropriateness.

• Integrates mobile application analytics with standardised implementation measures to capture digital engagement and real-world usability.

• Incorporates functional near-infrared spectroscopy to explore physiological mechanisms underlying burnout recovery, linking cerebral oxygenation to behavioural outcomes.

• Conducted across community-based Mayo Clinic Health System (MCHS) sites, enhancing ecological validity and relevance to decentralised clinical settings.

• Limitations include the single-arm, region-restricted (MCHS) design, modest sample size and reliance on volunteer participants, which constrain generalisability; exploratory outcomes are intended to guide future trial refinement.

Introduction

Occupational distress, including professional burnout, has become a growing concern. Burnout refers to an occupational syndrome associated with affective and cognitive changes, including emotional exhaustion, depersonalisation or cynicism and diminished feelings of personal efficacy resulting from chronic occupational stress.¹ Physician burnout was reported at 62.8% in 2021 and remains at nearly 45.2% in 2023, an improvement but still high compared with earlier years.^{2 3} Burnout in nurses and allied health personnel is likewise prevalent in high-acuity environments. For example, a systematic review of meta-analyses estimated the prevalence of nurse burnout, which ranged broadly from 11% to 56%.⁴

Burnout in healthcare professionals is a serious and multifactorial issue influenced by both environmental and individual factors. Increased financial pressures, administrative demands, productivity expectations, workload and a lack of autonomy are frequently cited as contributing factors.¹ Furthermore, the rapid advancement of medical knowledge, the implementation of electronic health records and regulatory requirements creates additional pressures.⁵ Healthcare professionals also face scrutiny on metrics that may not accurately reflect the complexities of their work.⁶ Burnout among healthcare professionals leads to decreased productivity, impaired connections with patients and colleagues, lower patient satisfaction and reduced quality of work, all contributing to increased work-related stress, further fueling the cycle of burnout.^{1 6}

Burnout and chronic stress shift brain control from executive thinking to emotional reactivity

The chronic stress associated with factors that are outside the control of an individual (health professionals in this case) exerts detrimental effects on brain circuitry, particularly the prefrontal cortex (PFC).⁷ The PFC governs higher-order reasoning, social cognition and decision-making, including the integration, conceptualisation and critical evaluation of information.⁸ Chronic stress exposure, such as that seen in burnout, is associated with atrophy of PFC connections, weakening the thoughtful and critical thinking essential for professional and personal fulfilment.^{7 9}

This impairment in PFC functioning may manifest in the workplace as difficulty managing complex tasks, increased medical errors, suboptimal patient care, diminished commitment to professionalism, impaired social connections with patients and colleagues and a higher likelihood of unprofessional behaviours.^{6 10} Sleep deprivation, a common consequence of demanding clinical schedules, critically mediates chronic stress-induced PFC dysfunction by exacerbating fatigue and reducing PFC metabolic and physiological activity, thereby contributing to measurable cognitive deficits.^{11 12}

Chronic stress can reduce oxygenation of PFC in several ways. The fight or flight response triggered by stress causes blood vessels to constrict, reducing blood flow and oxygen delivery to the brain tissues.¹³ Chronic stress can lead to shallow, rapid breathing, which further decreases the efficiency of oxygen intake in the body.¹⁴ Functional neuroimaging studies, including functional near-infrared spectroscopy (fNIRS), show that reduced oxygenation in PFC correlates with diminished activation during tasks that require inhibitory control, working memory and complex reasoning.^{15 16} This hypometabolic state further weakens the PFC’s ability to regulate more primitive brain circuits, such as the amygdala, striatum and brainstem.⁹ Under these conditions, elevated norepinephrine and dopamine released in subcortical regions amplifies primitive reflexive habits, emotional reactivity and threat perception.⁷ This brain state pushes us toward quick, survival-focused reactions, like fear or irritability, instead of calm, deliberate problem solving.^{7 9} While this state may be useful in a true emergency, it works against individuals in the complex, high-stakes situations such as those faced in healthcare. In contrast, when stress-mitigating skills are practised, stress is more controllable, allowing the PFC to maintain regulatory dominance and foster adaptive coping.¹⁷

Overall, this neurobiological background highlights the brain’s natural stress response and explains how a diminished sense of control is linked to weakened PFC connections and oxygen metabolism. This pathway forms the mechanistic rationale for targeting PFC oxygenation as an intervention point in burnout.

Neural correlates of breathing practices

Advanced neuroimaging studies show that breathing rhythms can influence key aspects of brain physiology, including cerebrospinal fluid (CSF) circulation and vasomotor function throughout the brain.¹⁸ Evidence from electroencephalogram, functional magnetic resonance imaging (fMRI) and fNIRS supports that structured breathing can modulate neural oscillations, cerebral perfusion and autonomic tone, all of which have direct implications for PFC health and executive control.¹⁹

Enhanced brain oxygenation and modulation of brain activity

Controlled and structured breathing patterns have been shown to increase cerebral oxygen levels and stabilise brain activity, contributing to improved emotional regulation and cognitive performance.19,22 One important physiological marker of this effect is heart rate variability (HRV), the natural variation in time between heartbeats which reflects parasympathetic nervous system activity and is closely linked to stress regulation and resilience.²³

Structured breathing has been found to increase alpha wave activity (8–13 Hz) associated with relaxed, focused attention while decreasing theta wave activity (4–8 Hz) that is linked to mental noise and rumination.¹⁹ fMRI studies demonstrate that structured breathing enhances the blood-oxygen-level dependent signal in cortical and subcortical areas such as the medulla and hippocampus, regions where activation is positively correlated with HRV.^{23 24} In contrast, HRV is negatively correlated with activity in the anterior insula, dorsomedial PFC and occipital cortex.²⁵

These neural and physiological changes are directly relevant to burnout, where chronic stress and sleep deprivation weaken PFC connections and reduce its ability to regulate primitive brain circuits such as the amygdala, striatum and brainstem.⁷ By improving cerebral oxygenation and strengthening functional connectivity within the PFC, structured breathing may help restore executive regulation and reduce maladaptive, reactive brain states (figure 1).^{7 20 21}

Figure 1. Proposed neurophysiological pathway linking burnout to impaired executive control and heightened emotional reactivity. Chronic stress and sleep deprivation reduce prefrontal cortex (PFC) oxygenation, weakening its regulatory control over subcortical brain regions.

Cerebrospinal fluid dynamics during breathing practice

CSF and interstitial fluid (ISF) are needed to maintain central nervous system (CNS) homeostasis. Beyond its mechanical cushioning role, CSF also facilitates the distribution of nutrients and hormones within the CNS. CSF and ISF collectively play a critical role in removing solutes and metabolic waste from interstitial spaces.²⁴ This is an important function implicated in the pathophysiology of a vast array of neurodegenerative and neuroinflammatory conditions.²⁶

CSF flow is controlled primarily by alterations in the CNS vascular bed, including cardiac pulsations and respiration, as well as secondarily by alterations in body position and the cough reflex.²⁷ Deep inspiration creates a forceful upward flow of CSF from the lumbar space up the spinal canal into the cranial vault. With expiration, CSF flows partially downward, creating a rhythmic bidirectional flow. The fall in intrathoracic pressure on inspiration enables venous drainage from the brain and neck into the thoracic cavity.^{18 28} This temporary reduction of intracranial blood volume is compensated by an upward shift of CSF to maintain intracranial pressure equilibrium, as per the Monro-Kellie doctrine.²⁹ Deep, structured breathing thus produces dynamic pressure changes that actively drive CSF circulation (upward on inspiration and downward on expiration).³⁰ By enhancing CSF circulation, structured breathing may improve oxygen and nutrient delivery to the PFC while aiding in the clearance of metabolic by-products, supporting recovery from burnout-related neural fatigue.^{18 30 31}

While breathing training is rapidly gaining attention as a potential intervention to boost brain function and autonomic regulation, few studies have integrated objective diaphragm movement assessment, fNIRS measurement of cortical oxygenation and validated mental health/burnout scales in the same protocol.32,34 Our method bridges this gap and aims to establish a clinically applicable breathing practice programme for reducing and preventing burnout in healthcare professionals.

Research question

Can a structured breathing-based intervention be implemented and accepted among healthcare professionals, as reflected by satisfactory recruitment, retention, adherence and participant satisfaction? Additionally, how usable and engaging is the mobile application platform for supporting intervention delivery and monitoring? Exploratorily, what are the preliminary physiological and mental health trends and variability of the breathing-based intervention, including changes in cerebral oxygenation and local tissue haemodynamics measured by fNIRS, to inform the design of a future larger-scale trial?

Study objectives

Primary objective

To assess the feasibility, participant satisfaction, acceptability and implementation of a structured breathing-based intervention among healthcare professionals. Feasibility will be determined by the ease of recruitment and retention through the final assessment. Participant satisfaction will be assessed through a mixed-methods approach combining quantitative surveys and qualitative participant interviews. Acceptability and implementation appropriateness will be evaluated using satisfaction ratings and standardised implementation outcome measures, including the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM).³⁵

Secondary objective

To evaluate 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.

Exploratory objective

To assess the feasibility of collecting psychological measures and to describe variability and preliminary descriptive trends on cerebral oxygenation and local tissue haemodynamics, as measured by fNIRS, along with changes in mental health outcomes. These exploratory analyses are intended to examine preliminary trends and estimate variability and effect sizes that can inform the design and power calculations of future definitive trials. The study is not powered to test effectiveness or efficacy hypotheses at this stage.

Methods

This protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025 statement³⁶ for the reporting of clinical trial protocols. Relevant guidance from the Consolidated Standards of Reporting Trials (CONSORT) 2010 Extension for Pilot and Feasibility Trials³⁷ was also integrated to align with the feasibility objectives and implementation-focused nature of this study.

As a pilot feasibility study, this trial is not designed to test hypotheses but to evaluate whether the structured breathing-based intervention can be implemented effectively within a healthcare setting.³⁸ Progression to a future large-scale, hybrid effectiveness–implementation trial will be based on meeting predefined feasibility benchmarks. These include recruitment of at least 75% of eligible participants, retention of 80% or more through the 4-month follow-up, mean AIM, IAM and FIM scores of 4.0 or higher on a 5-point scale and adherence of at least 70% to self-reported or app-logged breathing sessions.^{16 35 39} Achieving these thresholds will indicate readiness to scale the intervention, while values within approximately 10 percentage points of these targets will signal the need for protocol modification before proceeding to a definitive trial. The study will begin on 27 November 2025 and is anticipated to be completed by 1 June 2026.

Study design

This is a single-arm, non-randomised pilot feasibility study designed to evaluate the feasibility, participant satisfaction, acceptability and implementation appropriateness (primary objective), as well as engagement (secondary objective) and describe magnitude of variability and feasibility of collecting psychological and cerebral haemodynamic measures (exploratory objective) of a structured breathing-based intervention among healthcare professionals, including clinicians and nurses.

Study setting

This study is planned to be conducted at the Mayo Clinic’s community-based care setting provided by Mayo Clinic Health System (MCHS), which serves patients across urban and rural settings primarily in the Upper Midwest.⁴⁰ The MCHS has four large hospitals, two each in Minnesota (MN) and Wisconsin (WI) where this study will be conducted. MCHS service area presents with rural health challenges as characterised by high disease burden and patient flow, limited specialty access and growing need for health innovations. The MCHS is staffed by >1000 physicians and >14 000 allied staff across MN, WI and IA. MCHS includes 16 hospitals (including 10 rural critical access hospitals), 41 multispecialty clinics and a mobile health clinic, and supports 2 million patient visits annually.

Participants and recruitment

Inclusion criteria

This single-arm intervention trial will enrol healthcare professionals who meet the following eligibility criteria: (1) currently employed as a clinician (MD/MBBS/DO/PA) or nurse at one of the four designated MCHS sites: Eau Claire, WI; La Crosse, WI; Mankato, MN; or Albert Lea, MN, (2) score greater than 40 on the Copenhagen Burnout Inventory (CBI)⁴¹ (questions 1–6), (3) physically able to perform light exercise and (4) have access to a smartphone or tablet. We plan to recruit n=40 healthcare professionals, targeting an equal distribution of clinicians and nurses (1:1 ratio when possible).

Exclusion criteria

The exclusion criteria include (1) severe or unstable medical condition that could interfere with participation or data collection, (2) active neurological condition (including seizure disorder, traumatic brain injury or stroke) that could affect cognitive functioning or brain imaging results, (3) chronic lung disease (eg, chronic obstructive pulmonary disease, cystic fibrosis) or aneurysm and (4) current pregnancy or planning to become pregnant during the study period.

Participants are asked to avoid caffeinated products on the morning of the fNIRS study visits. To accommodate potential scheduling conflicts, there will be a permissible leeway of up to 3 weeks for each visit. Due to potential scheduling conflicts with participants’ work schedules, we will allow a 3-week leeway for completing visits.

Outreach and engagement plan

To facilitate recruitment and increase awareness of the study, we will host a Breathing Symposium at each of the four participating MCHS sites—Eau Claire, WI; La Crosse, WI; Mankato, MN; and Albert Lea, MN. These symposia will be open to all clinicians and healthcare staff and will focus on:

• Educating attendees about burnout, its neurobiological basis and the impact of chronic stress on brain health.

• Presenting the scientific evidence for structured breathing techniques as a potential intervention for improving mental well-being.

• Demonstrating breathing practices and their physiological effects.

• Providing a live fNIRS demonstration to show how brain oxygenation and deoxygenation can be measured in real time during breathing activities.

On-site recruitment activities

A study-specific Clinical Research Coordinator (CRC) will be present at each symposium to:

1. Provide printed flyers with study details, eligibility criteria and contact information for the research team.

2. Engage with interested attendees, answer questions and offer initial eligibility screening information.

3. Collect contact details from potential participants who express interest in enrolling.

The MCHS Well-Being Office will distribute an email announcement to all MCHS employees when recruitment begins. These combined in-person and electronic outreach strategies are designed to maximise awareness, ensure broad reach across the participating sites and facilitate balanced enrolment of physicians and nurses.

Intervention

Each participant will undergo a 4-month online systematic breathing intervention and complete the pre- and post-intervention surveys and fNIRS. No randomisation or allocation concealment is used, as this is a single-arm pilot feasibility study. The CRC and principal investigators (PS and PHM) will review attendance logs and app analytics monthly to ensure the intervention is delivered as planned.

Breathing practice protocol

The structured online (through mobile app) and in-person breathing practices (in-person practice is not required for this study) will be led by experienced instructors. The breathing practice focuses on conducting soft and gentle exercising to help participants naturally relax and strengthen the core muscles necessary for better breathing control, thereby improving one’s everyday natural breathing pattern over time. It is designed to be suitable for all participants, ensuring accessibility and ease of practice. The programme supports online video modules so participants can follow and practise at their own pace, supplemented by standardised written materials that outline the practice principles and postures. The breathing practice applied in the study is based on a beginner level programme. Adopting a structured breathing practice programme helps avoid potential biases from experimenter-led sessions, ensuring consistency and reproducibility.

Participants will register and enrol in the official breathing programme, joining their regular practice sessions like any other members, without disclosing their participation in the study to fellow members. The breathing practice instructors will be informed about the participants’ enrolment in the study, specifically their first name and age, but will not be given any other study details. No direct identifiers will be shared. No post-trial intervention is provided; participants receive standard community referrals and treatment after the completion of this trial. The breathing mobile application will be developed for research purposes. It is not designed for medical use nor as a therapeutic intervention and will not be a commercial product.¹⁸

Breathing practice sessions for participants

• (Required) Participants will complete two real-time online sessions with breathing instructors and the study team: an initial instruction session and a follow-up session, each about 60 min. The follow-up session should take place within 45 days of the first session. Depending on availability, the initial instruction session may be conducted in person.

• (Required) Participants are encouraged to engage in 15–36 min self-practice sessions, ideally three times per week, with a minimum of one session per week. During the initial session, a stepwise approach will be discussed with participants to help set realistic goals, starting with an easy and manageable schedule and building up gradually as they feel comfortable.

• (Optional) Weekly real-time online practice sessions, conducted via video conference, are available to provide live, interactive instruction in the breathing practices. These sessions complement self-practice by offering real-time guidance, progress evaluation and individualised feedback from instructors. More than 10 weekly sessions are offered. Feedback will be shared with both participants and the study team to monitor training effectiveness and adaptation. Participants are encouraged to continue attending these weekly sessions as an option.

Participants are encouraged to regularly communicate with instructors and the study team about their progress and any questions they may have about the practice. The study team will respond to communications and prompt participants appropriately. This routine serves as a check-in to encourage regular engagement with the breathing exercises and to help maintain a record of participation. Participants may also increase the frequency of their daily practice sessions if desired. Breathing practice frequency is encouraged but not mandatory, and non-adherence does not result in withdrawal.

Data collection methods

The data will be collected through fNIRS recording app and RedCap surveys (noted in outcomes sections) and mobile application.

fNIRS assessment methods will be used to measure cerebral haemodynamic patterns in participants, focusing on changes in brain activity in the PFC, which is involved in mood regulation and cognitive function. fNIRS outcomes are collected solely to assess feasibility, tolerability and data quality, not intervention-related physiological effects.

Detailed information about the fNIRS device (Obelab) and specific task protocols is provided in the Device Information and Procedures sections of the protocol (figure 2).⁴² The brain imaging acquisition will take about 30 min to complete, including placing the device over the head and completing resting-state and task-based measurements. The task-based measurement includes word fluency test and deep breathing session. During the study, the subject wears the fNIRS device, and the researcher runs the software on the tablet screen to measure changes in the subject’s oxyhaemoglobin.

Figure 2. Functional near-infrared spectroscopy (fNIRS) device and tablet used to measure cerebral oxygenation in real time during breathing and cognitive tasks.

Adherence and compliance

Mobile breathing application will track adherence and compliance. During one of the in-person meetups, we will go through how to use the mobile app and provide instruction. Participants who withdraw will not be replaced; attrition will be analysed as a feasibility outcome.

1. Participant engagement: Participants will receive biweekly breathing tips through email, offering encouragement and an opportunity to ask any questions. If a participant does not communicate with the study team for 5 days on their daily practice, the study team can send a reminder via their preferred contact method (ie, text message, telephone call or email). This ensures ongoing engagement and addresses any participant concerns. For the breathing group, any feedback from the instructors will be relayed to the participants, and vice versa. Variability in engagement is treated as a feasibility outcome rather than a source of bias, consistent with pilot trial methodology.

2. Emphasis on honest reporting: We encourage participants to report their practice habits honestly and without any pressure. Self-practice is not mandatory, and there’s no need to overcommit. What’s most important is that participants provide genuine feedback on their actual practice. The study seeks to understand natural compliance patterns, and we value honest, pressure-free reporting over strict adherence to practice frequency.

Data collection timeline

This project allows participants to complete their visit-related activities online or in person. The study timeline spans October 2025 through June 2026 (table 1).

Table 1. Schedule of enrolment, interventions and assessments (participant timeline).

Trial period	Enrolment	Post-enrolment	Follow-up	Close-out
Timepoint	−t₀ to 0	0 months (Visit 1)	2 months (Visit 2)	4 months (Visit 3)
Enrolment
Eligibility screen	X
Informed consent	X
Intervention
Mobile breathing-based intervention (setup, registration, practice)		X
Continued app-guided breathing practice		→	→	→
Assessments
Survey questionnaires (REDCap)		X	X	X
Functional near-infrared spectroscopy; site-specific)		X		X (optional)
Participant satisfaction and usability (embedded in surveys)		X	X	X
Adherence monitoring via mobile application		→	→	→

Outcomes

The primary outcomes of this feasibility study focus on implementation-related domains, including (1) recruitment and retention metrics derived from study logs (eg, accrual velocity, time to first enrolment and completion rates); (2) acceptability and participant satisfaction, assessed through structured surveys and qualitative interviews at the end of the 4-month intervention; and (3) implementation appropriateness and feasibility of intervention delivery, measured using the AIM, IAM and FIM³⁵ at 2 and 4 months.

The secondary outcome pertains to usability and engagement with the mobile platform, assessed through mobile application analytics (logins, session duration and completion rates) and the System Usability Scale.⁴³ These data will be captured continuously through automated tracking and summarised at 4 months.

Exploratory outcomes include changes in psychological and physiological indicators from baseline to 2-month and 4-month follow-up. Psychological indicators encompass burnout (CBI),^{32 41} mental health (Patient Health Questionnaire-9,⁴⁴ Generalised Anxiety Disorder-7,⁴⁵ Perceived Stress Scale,⁴⁶ sleep and fatigue (Pittsburgh Sleep Quality Index,⁴⁶ Modified Fatigue Impact Scale,⁴⁷ and professional well-being (Professional Fulfilment Index,⁴⁸ Linear Analogue Self-Assessment,⁴⁹ Brief Resilience Scale.⁴⁹ Physiological outcomes will be derived from fNIRS assessments of cerebral oxygenation and haemodynamics, obtained at baseline and 4 months in a subset of participants. All outcomes and corresponding assessment schedules are summarised in table 2.

Table 2. Summary of study measures, instruments and assessment schedule.

Domain	Measure/instrument	Outcome type	Assessment schedule
Primary outcomes
Feasibility (recruitment and retention)	Recruitment logs (accrual velocity, time to first enrollment), retention and adherence tracking logs	Feasibility—recruitment yield, retention and adherence rates	Continuous monitoring throughout recruitment and follow-up
Acceptability and participant satisfaction	Participant satisfaction survey; qualitative interview guide	Acceptability and participant satisfaction	End of intervention (4 months)
Implementation appropriateness	AIM; IAM; FIM	Implementation appropriateness and feasibility of intervention delivery	2 month and 4 month
Secondary outcomes
Usability and engagement	Mobile application analytics (logins, session duration, completion rate); SUS	Digital engagement, usability and adherence patterns	Continuous (automated data capture) and at 4 months
Exploratory outcomes
Burnout	CBI	Psychological indicator (burnout symptoms)	Baseline, 2 month, 4 month
Mental health	PHQ-9; GAD-7; PSS-4	Psychological indicators (depression, anxiety, perceived stress)	Baseline, 2 month, 4 month
Sleep and fatigue	PSQI; MFIS	Psychological indicators (sleep quality, fatigue)	Baseline, 2 month, 4 month
Professional well-being	PFI; LASA; BRS	Psychological indicators (fulfilment, resilience, well-being)	Baseline, 2 month, 4 month
Physiological	fNIRS	Physiological indicators (cerebral oxygenation and haemodynamics)	Baseline and 4 month (subset of participants)

AIM, Acceptability of Intervention Measure; BRS, Brief Resilience Scale; CBI, Copenhagen Burnout Inventory; FIM, Feasibility of Intervention Measure; fNIRS, functional Near-Infrared Spectroscopy; GAD-7, Generalised Anxiety Disorder-7; IAM, Intervention Appropriateness Measure; LASA, Linear Analogue Self-Assessment; MFIS, Modified Fatigue Impact Scale; PFI, Professional Fulfilment Index; PHQ-9, Patient Health Questionnaire-9; PSQI, Pittsburgh Sleep Quality Index; PSS-4, Perceived Stress Scale-4; SUS, System Usability Scale.

Participant retention, withdrawal and discontinuation

Participant retention will be promoted through flexible scheduling, regular reminders from the CRC and engagement messages through the study’s mobile application. Any participant who chooses to withdraw from the study or discontinues the intervention will be asked, if willing, to complete a brief exit survey to document their reasons for withdrawal (eg, time constraints, technical issues, loss of interest or adverse experience). Data collected up to the point of withdrawal, including baseline and interim assessments, will be retained and included in descriptive analyses in accordance with SPIRIT 2025 recommendations. The CRC will record all withdrawals in the study tracking log, and the PI will review these monthly to identify potential barriers to retention. No replacement participants will be enrolled once recruitment is complete.

Statistical analysis

Analyses will follow the CONSORT 2010 Extension for Pilot and Feasibility Trials^{37 50} and the SPIRIT 2025 guidelines,³⁶ emphasising feasibility, acceptability and implementation readiness rather than hypothesis testing. Because this is a pilot feasibility study, formal statistical hypothesis testing and power calculations are not planned. Instead, all quantitative outcomes will be summarised descriptively using means, SD, medians with IQRs and proportions with 95% CIs, as appropriate. Progression criteria, rather than p values, will guide interpretation of feasibility and readiness for scale-up, consistent with the National Center for Complementary and Integrative Health guidance on pilot studies.³⁸ Meeting the prespecified benchmarks for recruitment, retention, adherence and acceptability will indicate that the intervention is feasible and warrants evaluation in a fully powered hybrid effectiveness–implementation trial.

All analyses will be conducted using standard statistical software (eg, R). Continuous variables will be summarised as means with SD or medians with IQRs, and categorical variables as frequencies and percentages. Feasibility will be evaluated based on prespecified thresholds: recruitment of at least 75% of eligible participants, retention of ≥80% through the 4-month follow-up and adherence of ≥70% to self-reported or app-logged breathing sessions. Recruitment rate (participants per week), time to first enrolment, retention and adherence will be summarised descriptively with 95% CIs. Meeting or exceeding these thresholds will indicate feasibility of scaling the intervention. Acceptability and implementation appropriateness will be assessed using mean scores from the AIM, IAM and FIM, complemented by qualitative feedback analysed thematically to identify barriers and facilitators.

Mobile application usability and engagement metrics (eg, logins, session duration, completion rate) will be summarised descriptively. Exploratory outcomes, including burnout, depression, anxiety, perceived stress, sleep, fatigue, well-being and physiological measures from fNIRS, will be analysed descriptively across baseline, 2-month and 4-month assessments. Changes over time will be reported as mean or median differences with 95% CIs to estimate variability and potential trends. No formal hypothesis testing will be conducted. Findings will be interpreted descriptively, and estimates will be used to guide effect-size estimation, power calculation and protocol refinement for a future fully powered hybrid effectiveness–implementation trial.

Patient and public involvement

Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

Ethics and dissemination

This study has been reviewed and approved by the Mayo Clinic IRB #25-009320. The trial was prospectively registered on ClinicalTrials.gov prior to participant enrolment (NCT07218458). Participants will receive US$50 for each completed in-person visit (baseline at 0 months and follow-up at 4 months) and US$25 for the online visit (2 months). The maximum total remuneration for completing all study visits is US$125. Payments will be provided after each visit is completed.

All participants will provide informed consent prior to participation obtained by a trained CRC. Participant safety will be safeguarded by the CRCs. Given the behavioural and minimal-risk nature of this feasibility study, serious adverse events (SAEs) are not anticipated. However, any untoward medical or psychological occurrence temporally associated with study participation such as dizziness, light-headedness, hyperventilation, emotional distress or unexpected discomfort will be considered an adverse event (AE). The CRC will document all AEs in the study log, noting onset, duration, resolution and relationship to the intervention. Participants experiencing significant distress during a session will be offered a brief debriefing and referred to appropriate support resources as outlined in the protocol safety plan. The PI will review AE logs monthly, and all SAEs or unexpected events will be reported promptly to the Mayo Clinic IRB in accordance with institutional policy. Aggregate AE data will be included in study progress reports and final dissemination materials.

All electronic data will be stored on secure, password-protected Mayo Clinic servers, with access restricted to authorised study personnel; de-identified data will be retained in accordance with institutional and National Institutes of Health (NIH) data-sharing policies. Data management will adhere to Mayo Clinic policies and NIH data-sharing requirements.

The study findings will be disseminated through peer-reviewed publications, conference presentations and community reports shared with participants and local stakeholders. A plain-language summary of results will also be posted on ClinicalTrials.gov. De-identified datasets may be deposited in a suitable research repository in accordance with Mayo Clinic policy and funder requirements.

Discussion

Principal findings

This single-arm pilot feasibility study will evaluate the practicality, acceptability and preliminary descriptive trends of a structured breathing-based wellness intervention for healthcare professionals. Feasibility will be assessed through prespecified quantitative thresholds for recruitment, retention, adherence and acceptability, complemented by qualitative feedback to understand barriers and facilitators of participation. Exploratory analyses will describe trends in burnout, stress and well-being indices. These feasibility metrics are consistent with established criteria used in behavioural, digital health and implementation-focused pilot trials and will inform key design parameters for a subsequent randomised study.

The inclusion of fNIRS represents a novel methodological innovation. fNIRS enables the quantification of cortical oxygenation and haemodynamic responses associated with the breathing intervention, offering an objective physiological correlate of engagement and mental recovery. Incorporating this neurophysiological measure provides an opportunity to explore early mechanistic signals and enhance participant motivation through awareness of tangible biological effects. To our knowledge, no previous feasibility study has integrated fNIRS as both an implementation and exploratory outcome measure in a wellness intervention targeting clinician burnout.

Trial oversight and monitoring

Given the minimal-risk, behavioural nature of this pilot feasibility study, no independent Data Monitoring Committee will be established. Study safety, data integrity and ethical conduct will be overseen by the PI and Mayo Clinic IRB. Oversight procedures will include monthly reviews by the CRC to ensure data completeness and participant safety, as well as quarterly evaluations by the PI to monitor protocol adherence, recruitment progress and any AE reports. All protocol amendments will be promptly communicated to the Mayo Clinic IRB, ClinicalTrials.gov and all study personnel before implementation. Participants will provide written informed consent for survey, interview and physiological data collection. No biospecimens or genetic testing will be conducted. Confidentiality will be safeguarded through the use of secure, password-protected RedCap databases, and all data will be de-identified prior to analysis and reporting.