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NCT Number: NCT07220421

Foundational Programs to Combat Clinician Stress

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

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.

    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.

Secondary outcomes

  1. 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.

    Millisecond (ms) is the unit for HRV.

  2. 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.

    Sleep score is a normalized score that ranges from 0 to 100, with 100 being the best possible score indicating ideal sleep quality.

  3. 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).

    PROMIS 8a: 8-item Emotional Distress - Depression Scale: The score ranges from 8 to 40, and higher scores indicate worse depression.

  4. 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).

    PROMIS 8a: 8-item Emotional Distress - Anxiety Scale: The score ranges from 8 to 40, and higher scores indicate worse anxiety.

  5. 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).

    PROMIS 8a: 8-item Sleep-Related Impairment Scale: The score ranges from 8 to 40, and higher scores indicate worse sleep-related impairment.

  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).

    Intent to Leave Scale (1 item): The score ranges from 1 to 5, and higher scores indicate stronger intent to leave.

  7. 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).

    Stanford Self-Valuation Scale (4 items): The score ranges from 4 to 20, and higher scores indicate better self-esteem and self-worth.

  8. 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).

    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.

  9. 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).

    Social Connectedness Scale-Revised (SCS-R; 20 items): The score ranges from 20 to 100, and higher scores indicate better social connectedness.

  10. 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).

    Mindful Attention Awareness Scale (MAAS, 5 items): The score ranges from 5 to 35, and higher scores indicate better mindfulness.

  11. 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).

    12-item Attention-Related Cognitive Errors Scale (ARCES): The score ranges from 12 to 60, and higher scores indicate more cognitive errors.

  12. 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).

    Self-Reported Medical Errors Scale (SRME, 4 items): The score ranges from 4 to 20, and higher scores indicate more frequent medical errors.

Study contacts

Contact information is provided by the study sponsor or research team.

Halle Becker, MPH

CONTACT

[email protected]

7175441777

Jonathan Derr, MBA

CONTACT

[email protected]

7175441777

Sponsors and collaborators

Lead sponsor

Lancaster General Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

Evaluate Foundational Wellness Programs to Help Reduce Clinician Burnout and Improve Professional Fulfilment in Health Care Professionals.

Acronym: FACCTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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