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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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). |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Halle Becker, MPH | Contact | 7175441777 | Halle.Becker@pennmedicine.upenn.edu | |
| Jonathan Derr, MBA | Contact | 7175441777 | Jonathan.Derr@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mrinalini Meesala, MD | Penn Medicine / Lancaster General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38100103 | Background | 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. | |
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|
| 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. |
|
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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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). | 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). |
| Princeton Medical Center / Princeton Health affiliated sites | Recruiting | Plainsboro | New Jersey | 08536 | United States |
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| Penn Medicine Lancaster General Health | Recruiting | Lancaster | Pennsylvania | 17602 | United States |
|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D002055 | Burnout, Professional |
| D013315 | Stress, Psychological |
| D000092862 | Psychological Well-Being |
| D000073397 | Occupational Stress |
| D053120 | Respiratory Aspiration |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009784 | Occupational Diseases |
| D000077062 | Burnout, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
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| ID | Term |
|---|---|
| D012119 | Respiration |
| ID | Term |
|---|---|
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided