Foundational Programs to Combat Clinician Stress

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorLancaster General Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

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),

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Sudarshan Kriya Yoga (SKY) Breathing and Sahaj MeditationExperimental treatment 1 intervention
Group B: Health Education Program (HEP)Active comparator 1 intervention

Trial outcomes

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.

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.

Time frame
Assess at Baseline (week1), Midpoint (week 4), and Endpoint (week 6).

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.

Millisecond (ms) is the unit for HRV.

Time frame
Daily for 6 weeks.
2

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.

Time frame
Daily for 6 weeks.
3

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.

Time frame
Assess at Baseline (week 1) and Endpoint (week 6).
4

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.

Time frame
Assess at Baseline (week 1) and Endpoint (week 6).

Other outcomes

Sponsors and contacts

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Lancaster General Hospital

Lead sponsor

Massachusetts General Hospital

Collaborator