Foundational Programs to Combat Clinician Stress

NCT07220421 | Recruiting

• 1 other identifier: 857510
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, randomized, controlled clinical trial in which clinicians from University of Pennsylvania Health Systems (UPHS) including Penn Medicine- Lancaster General Health (LGH) and Massachusetts General Hospital (MGH) are offered a well-known program to help reduce clinician burnout: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation Intervention.

Conditions

Burnout, Professional; Stress, Psychological; Stress, Physiological; Psychological Well-Being; Mind-Body Therapies; Work Related Stress

Keywords

Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation; Stress Reduction; Healthcare Professional Burnout; Workplace Wellbeing; Work Life Balance; Physician; Healthcare Provider; Cognitive Performance; Cognitive Attention; Depression; Anxiety; Sleep; Heart Rate Variability; Resilience; Social Connection; Self-Valuation; Professional Fulfilment; Medical Errors; Physician Turnover; Healthcare Economics; Occupational Burnout

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index.

  The unit of measurement for the Stanford Professional Fulfillment Index is Likert scale scores, reflecting how often the individual experiences aspects of fulfillment or burnout. These are ordinal scores with ranked responses, but the exact intervals between the scores are not numerically defined.

  Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).

Secondary Outcomes (12)

• Evaluation of Heart Rate Variability (HRV) as a physiologic metric for well-being in clinicians through continuous readings using the Oura Ring.

  Daily for 6 weeks.

• Evaluation of sleep scores as physiologic metrics for well-being in clinicians through continuous readings using the Oura Ring.

  Daily for 6 weeks.

• Evaluation of the impact of the programs on depression as measure by the PROMIS 8a: 8-item Emotional Distress - Depression scale.

  Assess at Baseline (week 1) and Endpoint (week 6).

• Evaluation of the impact of the programs on anxiety as measure by the PROMIS 8a: 8-item Emotional Distress - Anxiety scale.

  Assess at Baseline (week 1) and Endpoint (week 6).

• Evaluation of the impact of the programs on sleep as measure by the PROMIS 8a: 8-item Sleep-Related Impairment scales.

  Assess at Baseline (week 1) and Endpoint (week 6).

Study Arms (2)

Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation

EXPERIMENTAL

The SKY Breathing and Sahaj Meditation program involves teaching cyclical breathing techniques with various hand positions and a Guided Meditation practice. This program also includes teaching Cognitive Reframing Tools (CRTs) for emotional regulation.

Behavioral: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation

Health Education Program (HEP)

ACTIVE COMPARATOR

The Health Education Program (HEP) curriculum reviews various health related topics and facilitates group discussion on such topics. This program includes teachings on topics such as mental health, exercise and nature, nutrition and hydration, and self-care. It provides a learning experience on health topics and gives participants skills, tools, and knowledge to live healthier lives.

Other: Health Education Program (HEP)

Interventions

Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation BEHAVIORAL

The SKY intervention is comprised of a week of baseline HRV and sleep metric readings, followed by an onboarding week of 3-day, 3.5 hours/day, online SKY workshops with a live instructor (10.5 hours total), followed by weekly online follow-up sessions with a live instructor (1 hour each) for a period of 4 weeks. Clinicians also practice on their own daily for 45 minutes during these 4 weeks and wear an Oura Ring continuously. They do not have to do their daily practice on the days that they have a follow-up session. Well-being and burnout metrics will be assessed using PFI Week 1, Week 4, and Week 6. Evaluation of the impact of the program on other factors as measured by other questionnaires Week 1 and Week 6. HRV and sleep metrics will be used as a physiologic marker of well-being and will be measured continuously via Oura Ring.

Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation

Health Education Program (HEP) OTHER

The HEP coaches will provide these sessions online with an initial onboarding week of 2-day, 3 hours/day online HEP workshop followed by weekly online follow up sessions for 2 hours each with a live instructor. They will also pursue 45 min of daily practice for a period of 4 weeks. They do not have to do their daily practice on the days that they have a follow-up session. Well-being and burnout metrics will be assessed using PFI Week 1, Week 4, and Week 6. Evaluation of the impact of the program on other factors as measured by other questionnaires Week 1 and Week 6. HRV and sleep metrics will be used as a physiologic marker of well-being and will be measured continuously via Oura Ring.

Health Education Program (HEP)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age,
• UPHS or MGH clinician (physician, APP, CRNP, PA, psychologist),
• Access to smart phone and internet,
• Ability to give informed consent,
• Interested in wearing an Oura ring and being part of a study to evaluate breath and meditation-derived exercises,
• Willing to do relaxation exercise every day for 4 weeks.

You may not qualify if:

• Currently maintaining a regular/daily mind-body program practice (eg. meditation, yoga or breathing techniques),
• Atrial fibrillation,
• Pacemaker/defibrillator,
• Untreated or severe obstructive sleep apnea (AHI\>=30),
• History of diaphragm paralysis,
• Unable or unwilling to complete the workshop,
• Severe chronic obstructive pulmonary disease (COPD),
• Severe valvular heart disease,
• Prior or planned chest/abdominal or nasal/facial surgery within 6 months,
• Severe psychiatric illness (e.g. schizophrenia, schizoaffective disorder, bipolar disorder), active substance use, seizure disorder or major somatic illness (uncontrolled hypertension, lung disease, liver disease, cancer or heart disease).

Sponsors & Collaborators

• Lancaster General Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (6)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Princeton Medical Center / Princeton Health affiliated sites

Plainsboro, New Jersey, 08536, United States

RECRUITING

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

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  BACKGROUND

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  BACKGROUND

• Lee, R. M., Draper, M., & Lee, S. (2001). Social connectedness, dysfunctional interpersonal behaviors, and psychological distress: Testing a mediator model. Journal of Counseling Psychology, 48(3), 310-318.

  BACKGROUND

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MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological; Psychological Well-Being; Occupational Stress; Respiratory Aspiration; Depression; Anxiety Disorders

Interventions

Respiration

Condition Hierarchy (Ancestors)

Occupational Diseases; Burnout, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Mrinalini Meesala, MD

  Penn Medicine / Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halle Becker, MPH

CONTACT

7175441777; Halle.Becker@pennmedicine.upenn.edu

Jonathan Derr, MBA

CONTACT

7175441777; Jonathan.Derr@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: October 23, 2025
• Study Start: September 15, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)