Study Results
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Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2025-09-15
2026-05-31
Brief Summary
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Detailed Description
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The proposed prospective, randomized clinical trial will examine the effects of SKY in a large group of health care clinicians (physician, Advanced Practice Provider (APP), Certified Registered Nurse Practitioner (CRNP), Physician Assistant (PA), psychologist) within the US, examining the above constructs. Clinicians will be randomized one of 2 arms: SKY or an active control group.
This research initiative will enroll 90 clinicians in the SKY program. 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.
90 clinicians will be assigned as controls and participate in an active control group with Health Education Program (HEP). 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 Professional Fulfillment Index (PFI) collected at baseline (week 1), midpoint (week 4), and endpoint (week 6) in the SKY intervention and control group. HRV and sleep score will be used as physiologic markers of well-being and will be measured daily in the SKY and control groups. Secondary outcomes will be measured to evaluate the impact of the programs on other factors as measured by questionnaires at Week 1 and Week 6:
Depression (PROMIS 8a: 8-item Emotional Distress - Depression scale) Anxiety (PROMIS 8a: 8-item Emotional Distress - Anxiety scale) Sleep (PROMIS 8a: 8-item Sleep-Related Impairment scales) Intent to Leave (1 item) Self-Valuation (Stanford Self-Valuation Scale, 4 items) Stanford Impact of Work on Personal Relationships scale (IWPR, 4 items) Social Connectedness Scale-Revised (SCS-R; 20 items) Mindful Attention (5-item Mindful Attention Awareness Scale) Cognitive Errors (12-item Attention-Related Cognitive Errors Scale) Measurement of Self-Reported Medical Errors (SRME, 4 items)
The survey data will be statistically analyzed using linear mixed effects models. The goal of the project is to mitigate or reverse initial symptoms of clinician burnout with the SKY program at a statistically significant difference as compared to the control. The intended outcome is to implement the foundational wellness SKY program on a wider scale to other healthcare professionals
Further details about the study design and references can be found in the full study protocol, once uploaded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation
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.
Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation
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.
Health Education Program (HEP)
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.
Health Education Program (HEP)
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.
Interventions
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Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation
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.
Health Education Program (HEP)
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
25 Years
70 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Lancaster General Hospital
OTHER
Responsible Party
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Principal Investigators
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Mrinalini Meesala, MD
Role: PRINCIPAL_INVESTIGATOR
Penn Medicine / Lancaster General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Princeton Medical Center / Princeton Health affiliated sites
Plainsboro, New Jersey, United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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857510
Identifier Type: -
Identifier Source: org_study_id
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