Burnout, ProfessionalFACCTSNCT07220421
Foundational Programs to Combat Clinician Stress
A study testing Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation and Health Education Program (HEP) in people with Burnout, Professional and Stress, Psychological, run by Lancaster General Hospital at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Psychological, Stress, Physiological
- What is being tested?
- Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation and Health Education Program (HEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Sep 2025to May 2026
- 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-70 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jagpreet Chhatwal, PhD, 617-724-4487, JagChhatwal@mgh.harvard.edu
Jagpreet Chhatwal, PhD
- Recruiting
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17602
Halle Becker, MPH, 717-544-1777, Halle.Becker@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, Jonathan.Derr@pennmedicine.upenn.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Halle Miller, MPH, 717-544-1777, halle.miller@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, Jonathan.Derr@pennmedicine.upenn.edu
- Recruiting
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Halle Miller, MPH, 717-544-1777, halle.miller@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, Jonathan.Derr@pennmedicine.upenn.edu
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Halle Miller, MPH, 717-544-1777, halle.miller@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, Jonathan.Derr@pennmedicine.upenn.edu
- Recruiting
Princeton Medical Center / Princeton Health affiliated sites
Plainsboro, New Jersey, 08536
Halle Miller, MPH, 717-544-1777, halle.miller@pennmedicine.upenn.edu
Jonathan Derr, MBA, 717-544-1777, Jonathan.Derr@pennmedicine.upenn.edu
About this study
Official title: Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.
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.
Read the detailed description
This study will not only measure psychometric data and cognitive metrics for clinician burnout but also assess physiological marker of wellbeing by collecting Heart Rate Variability (HRV) data and sleep scores. We expect to see significant improvement in psychophysiologic metrics including depression, anxiety, sleep problems, cognitive overload, mindfulness and heart rate variability.
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
- Burnout, Professional, Stress, Psychological, Stress, Physiological, Psychological Well-Being, Mind-Body Therapies, Work Related Stress
- Being tested
- Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation, Health Education Program (HEP)
- 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
- Medical subject headings
- Burnout, Professional, Stress, Psychological, Psychological Well-Being, Occupational Stress, Respiratory Aspiration, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudarshan Kriya Yoga (SKY) Breathing and Sahaj MeditationBehavioural
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Health Education Program (HEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Millisecond (ms) is the unit for HRV.
Measured: Daily for 6 weeks.
Evaluation of sleep scores as physiologic metrics for well-being in clinicians through continuous readings using the Oura Ring.
Sleep score is a normalized score that ranges from 0 to 100, with 100 being the best possible score indicating ideal sleep quality.
Measured: 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.
PROMIS 8a: 8-item Emotional Distress - Depression Scale: The score ranges from 8 to 40, and higher scores indicate worse depression.
Measured: 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.
PROMIS 8a: 8-item Emotional Distress - Anxiety Scale: The score ranges from 8 to 40, and higher scores indicate worse anxiety.
Measured: 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.
PROMIS 8a: 8-item Sleep-Related Impairment Scale: The score ranges from 8 to 40, and higher scores indicate worse sleep-related impairment.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on intent to leave place of employment as measure by the Intent to Leave 1 item scale.
Intent to Leave Scale (1 item): The score ranges from 1 to 5, and higher scores indicate stronger intent to leave.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on self-valuation as measure by the Stanford Self-Valuation Scale, 4 items.
Stanford Self-Valuation Scale (4 items): The score ranges from 4 to 20, and higher scores indicate better self-esteem and self-worth.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on impact of work on personal relationships as measure by the Stanford Impact of Work on Personal Relationships scale (IWPR, 4 items).
Stanford Impact of Work on Personal Relationships Scale (IWPR): The score ranges from 4 to 20, and higher scores indicate worse impact of work on personal relationships.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on social connectedness as measure by the Social Connectedness Scale-Revised (SCS-R; 20 items).
Social Connectedness Scale-Revised (SCS-R; 20 items): The score ranges from 20 to 100, and higher scores indicate better social connectedness.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on mindful attention as measure by the 5-item Mindful Attention Awareness Scale.
Mindful Attention Awareness Scale (MAAS, 5 items): The score ranges from 5 to 35, and higher scores indicate better mindfulness.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on cognitive errors as measure by the 12-item Attention-Related Cognitive Errors Scale.
12-item Attention-Related Cognitive Errors Scale (ARCES): The score ranges from 12 to 60, and higher scores indicate more cognitive errors.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on self-reported medical errors as measure by the Measurement of Self-Reported Medical Errors (SRME, 4 items).
Self-Reported Medical Errors Scale (SRME, 4 items): The score ranges from 4 to 20, and higher scores indicate more frequent medical errors.
Measured: Assess at Baseline (week 1) and Endpoint (week 6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2025
- Study start15 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancaster General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Mrinalini Meesala, MD, Principal investigator, Penn Medicine / Lancaster General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220421
- Sponsor's protocol ID
- 857510
- Acronym
- FACCTS
- Status last verified
- Oct 2025
- First submitted
- 2 Sep 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ligibel JA, Goularte N, Berliner JI, Bird SB, Brazeau CMLR, Rowe SG, Stewart MT, Trockel MT. Well-Being Parameters and Intention to Leave Current Institution Among Academic Physicians. JAMA Netw Open. 2023 Dec 1;6(12):e2347894. doi: 10.1001/jamanetworkopen.2023.47894.
PubMed 38100103Carriere JS, Cheyne JA, Smilek D. Everyday attention lapses and memory failures: the affective consequences of mindlessness. Conscious Cogn. 2008 Sep;17(3):835-47. doi: 10.1016/j.concog.2007.04.008. Epub 2007 Jun 15.
PubMed 17574866Osman A, Lamis DA, Bagge CL, Freedenthal S, Barnes SM. The Mindful Attention Awareness Scale: Further Examination of Dimensionality, Reliability, and Concurrent Validity Estimates. J Pers Assess. 2016;98(2):189-99. doi: 10.1080/00223891.2015.1095761. Epub 2015 Nov 11.
PubMed 26560259Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651Trockel J, Bohman B, Wang H, Cooper W, Welle D, Shanafelt TD. Assessment of the Relationship Between an Adverse Impact of Work on Physicians' Personal Relationships and Unsolicited Patient Complaints. Mayo Clin Proc. 2022 Sep;97(9):1680-1691. doi: 10.1016/j.mayocp.2022.03.005.
PubMed 36058580Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
PubMed 20550019Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
PubMed 21697139Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
PubMed 29196982Trockel M, Sinsky C, West CP, Dyrbye LN, Tutty M, Carlasare L, Wang H, Shanafelt T. Self-Valuation Challenges in the Culture and Practice of Medicine and Physician Well-being. Mayo Clin Proc. 2021 Aug;96(8):2123-2132. doi: 10.1016/j.mayocp.2020.12.032. Epub 2021 Jun 28.
PubMed 34210511Descilo T, Vedamurtachar A, Gerbarg PL, Nagaraja D, Gangadhar BN, Damodaran B, Adelson B, Braslow LH, Marcus S, Brown RP. Effects of a yoga breath intervention alone and in combination with an exposure therapy for post-traumatic stress disorder and depression in survivors of the 2004 South-East Asia tsunami. Acta Psychiatr Scand. 2010 Apr;121(4):289-300. doi: 10.1111/j.1600-0447.2009.01466.x. Epub 2009 Aug 19.
PubMed 19694633Katzman MA, Vermani M, Gerbarg PL, Brown RP, Iorio C, Davis M, Cameron C, Tsirgielis D. A multicomponent yoga-based, breath intervention program as an adjunctive treatment in patients suffering from generalized anxiety disorder with or without comorbidities. Int J Yoga. 2012 Jan;5(1):57-65. doi: 10.4103/0973-6131.91716.
PubMed 22346068Doria S, de Vuono A, Sanlorenzo R, Irtelli F, Mencacci C. Anti-anxiety efficacy of Sudarshan Kriya Yoga in general anxiety disorder: A multicomponent, yoga based, breath intervention program for patients suffering from generalized anxiety disorder with or without comorbidities. J Affect Disord. 2015 Sep 15;184:310-7. doi: 10.1016/j.jad.2015.06.011. Epub 2015 Jun 24.
PubMed 26142611Hamilton-West K, Pellatt-Higgins T, Sharief F. Evaluation of a Sudarshan Kriya Yoga (SKY) based breath intervention for patients with mild-to-moderate depression and anxiety disorders. Prim Health Care Res Dev. 2019 Jun 20;20:e73. doi: 10.1017/S1463423619000045.
PubMed 32799993Sharma A, Barrett MS, Cucchiara AJ, Gooneratne NS, Thase ME. A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study. J Clin Psychiatry. 2017 Jan;78(1):e59-e63. doi: 10.4088/JCP.16m10819.
PubMed 27898207
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.
- ClinicalTrials.gov ID
- NCT07220421
- Acronym / sponsor ID
- FACCTS / 857510
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Lancaster General HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 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.
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.
Detailed description
This study will not only measure psychometric data and cognitive metrics for clinician burnout but also assess physiological marker of wellbeing by collecting Heart Rate Variability (HRV) data and sleep scores. We expect to see significant improvement in psychophysiologic metrics including depression, anxiety, sleep problems, cognitive overload, mindfulness and heart rate variability.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation | Experimental | Behavioral: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj MeditationThe 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. |
| Health Education Program (HEP) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 25-70 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,
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| Sudarshan Kriya Yoga (SKY) Breathing and Sahaj MeditationThe 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. | Behavioural | Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation |
| 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. | Other | Health Education Program (HEP) |
Primary outcome
Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index.
Time frame: Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).
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.
12 secondary outcomes
Evaluation of Heart Rate Variability (HRV) as a physiologic metric for well-being in clinicians through continuous readings using the Oura Ring.
Time frame: Daily for 6 weeks.
Evaluation of sleep scores as physiologic metrics for well-being in clinicians through continuous readings using the Oura Ring.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on intent to leave place of employment as measure by the Intent to Leave 1 item scale.
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on self-valuation as measure by the Stanford Self-Valuation Scale, 4 items.
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on impact of work on personal relationships as measure by the Stanford Impact of Work on Personal Relationships scale (IWPR, 4 items).
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on social connectedness as measure by the Social Connectedness Scale-Revised (SCS-R; 20 items).
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on mindful attention as measure by the 5-item Mindful Attention Awareness Scale.
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on cognitive errors as measure by the 12-item Attention-Related Cognitive Errors Scale.
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
Evaluation of the impact of the programs on self-reported medical errors as measure by the Measurement of Self-Reported Medical Errors (SRME, 4 items).
Time frame: Assess at Baseline (week 1) and Endpoint (week 6).
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 23 Oct 2025.
- Background: PubMed 38100103Ligibel JA, Goularte N, Berliner JI, Bird SB, Brazeau CMLR, Rowe SG, Stewart MT, Trockel MT. Well-Being Parameters and Intention to Leave Current Institution Among Academic Physicians. JAMA Netw Open. 2023 Dec 1;6(12):e2347894. doi: 10.1001/jamanetworkopen.2023.47894.
- Background: PubMed 17574866Carriere JS, Cheyne JA, Smilek D. Everyday attention lapses and memory failures: the affective consequences of mindlessness. Conscious Cogn. 2008 Sep;17(3):835-47. doi: 10.1016/j.concog.2007.04.008. Epub 2007 Jun 15.
- Background: PubMed 26560259Osman A, Lamis DA, Bagge CL, Freedenthal S, Barnes SM. The Mindful Attention Awareness Scale: Further Examination of Dimensionality, Reliability, and Concurrent Validity Estimates. J Pers Assess. 2016;98(2):189-99. doi: 10.1080/00223891.2015.1095761. Epub 2015 Nov 11.
- Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
- Background: PubMed 36058580Trockel J, Bohman B, Wang H, Cooper W, Welle D, Shanafelt TD. Assessment of the Relationship Between an Adverse Impact of Work on Physicians' Personal Relationships and Unsolicited Patient Complaints. Mayo Clin Proc. 2022 Sep;97(9):1680-1691. doi: 10.1016/j.mayocp.2022.03.005.
- Background: PubMed 20550019Buysse DJ, Yu L, Moul DE, Germain A, Stover A, Dodds NE, Johnston KL, Shablesky-Cade MA, Pilkonis PA. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep. 2010 Jun;33(6):781-92. doi: 10.1093/sleep/33.6.781.
- Background: PubMed 21697139Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 29196982Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Background: PubMed 34210511Trockel M, Sinsky C, West CP, Dyrbye LN, Tutty M, Carlasare L, Wang H, Shanafelt T. Self-Valuation Challenges in the Culture and Practice of Medicine and Physician Well-being. Mayo Clin Proc. 2021 Aug;96(8):2123-2132. doi: 10.1016/j.mayocp.2020.12.032. Epub 2021 Jun 28.
- Background: PubMed 19694633Descilo T, Vedamurtachar A, Gerbarg PL, Nagaraja D, Gangadhar BN, Damodaran B, Adelson B, Braslow LH, Marcus S, Brown RP. Effects of a yoga breath intervention alone and in combination with an exposure therapy for post-traumatic stress disorder and depression in survivors of the 2004 South-East Asia tsunami. Acta Psychiatr Scand. 2010 Apr;121(4):289-300. doi: 10.1111/j.1600-0447.2009.01466.x. Epub 2009 Aug 19.
- Background: PubMed 22346068Katzman MA, Vermani M, Gerbarg PL, Brown RP, Iorio C, Davis M, Cameron C, Tsirgielis D. A multicomponent yoga-based, breath intervention program as an adjunctive treatment in patients suffering from generalized anxiety disorder with or without comorbidities. Int J Yoga. 2012 Jan;5(1):57-65. doi: 10.4103/0973-6131.91716.
- 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.
Mrinalini Meesala, MD principal investigator
Penn Medicine / Lancaster General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation and Health Education Program (HEP) in people with Burnout, Professional and Stress, Psychological, run by Lancaster General Hospital at 6 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 6 inclusion and 10 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Halle Becker, MPH (7175441777, Halle.Becker@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect of well-being foundational programs on burnout in clinicians at hospital health systems utilizing the Stanford Professional Fulfilment Index. (time frame: Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).). 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 NCT07220421, which also lists 40 linked publications.
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 23 Oct 2025.