Foundational Programs to Combat Clinician Stress (FACCTS)

October 21, 2025 updated by: Lancaster General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Sub-Investigator:
          • Jagpreet Chhatwal, PhD
    • New Jersey
      • Plainsboro, New Jersey, United States, 08536
    • Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Sleep score is a normalized score that ranges from 0 to 100, with 100 being the best possible score indicating ideal sleep quality.
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).
PROMIS 8a: 8-item Emotional Distress - Depression Scale: The score ranges from 8 to 40, and higher scores indicate worse depression.
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).
PROMIS 8a: 8-item Emotional Distress - Anxiety Scale: The score ranges from 8 to 40, and higher scores indicate worse anxiety.
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).
PROMIS 8a: 8-item Sleep-Related Impairment Scale: The score ranges from 8 to 40, and higher scores indicate worse sleep-related impairment.
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).
Intent to Leave Scale (1 item): The score ranges from 1 to 5, and higher scores indicate stronger intent to leave.
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).
Stanford Self-Valuation Scale (4 items): The score ranges from 4 to 20, and higher scores indicate better self-esteem and self-worth.
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).
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.
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).
Social Connectedness Scale-Revised (SCS-R; 20 items): The score ranges from 20 to 100, and higher scores indicate better social connectedness.
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).
Mindful Attention Awareness Scale (MAAS, 5 items): The score ranges from 5 to 35, and higher scores indicate better mindfulness.
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).
12-item Attention-Related Cognitive Errors Scale (ARCES): The score ranges from 12 to 60, and higher scores indicate more cognitive errors.
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).
Self-Reported Medical Errors Scale (SRME, 4 items): The score ranges from 4 to 20, and higher scores indicate more frequent medical errors.
Assess at Baseline (week 1) and Endpoint (week 6).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lancaster General Hospital

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Mrinalini Meesala, MD, Penn Medicine / Lancaster General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Actual)

October 23, 2025

Study Record Updates

Last Update Posted (Actual)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 857510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burnout, Professional

Clinical Trials on Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe