Randomized Controlled Trial in Advance Stage Breast Cancer Patients for the Effectiveness on Stress Marker and Pain through Sudarshan Kriya and Pranayam.
Neeta Kumar, Sushma Bhatnagar, T Velpandian...
https://pubmed.ncbi.nlm.nih.gov/24347909/Actively Recruiting
Led by Lancaster General Hospital · Updated on 2025-10-23
180
Participants Needed
6
Research Sites
N/A
Total Duration
Researchers are evaluating the effects of foundational wellness programs on reducing clinician burnout and improving professional fulfillment among healthcare professionals at University of Pennsylvania Health Systems and Massachusetts General Hospital. This prospective, randomized clinical trial compares the Sudarshan Kriya Yoga SKY Breathing and Sahaj Meditation program to an active control group receiving a Health Education Program HEP. The study focuses on psychometric, cognitive, and physiological measures related to burnout and well-being. Participants are randomized into one of two groups the SKY intervention or the HEP control. The SKY program includes a baseline week of heart rate variability HRV and sleep tracking, followed by a 3-day online workshop totaling 10.5 hours with live instruction, then weekly 1-hour follow-up sessions for 4 weeks. Participants practice daily for 45 minutes and continuously wear an Oura Ring for physiological monitoring. The HEP group undergoes a 2-day, 3 hoursday online workshop, followed by weekly 2-hour sessions over 4 weeks, also practicing daily for 45 minutes and wearing the Oura Ring for continuous monitoring. Throughout the 6-week study, clinicians complete assessments of burnout using the Stanford Professional Fulfillment Index at baseline, midpoint, and endpoint. Daily HRV and sleep scores are collected via the Oura Ring. Additional questionnaires evaluate depression, anxiety, sleep impairment, intent to leave employment, self-valuation, impact of work on relationships, social connectedness, mindfulness, cognitive errors, and self-reported medical errors at the beginning and end of the study. Data will be statistically analyzed to determine the impact of these programs on clinician well-being and burnout.
CONDITIONS
Foundational Programs to Combat Clinician Stress
H
Halle Becker, MPH
J
Jonathan Derr, MBA
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Lancaster General Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Sudarshan Kriya Yoga (SKY) Breathing and Sahaj Meditation | Health Education Program (HEP) |
|---|---|---|
| What is it? | A structured program teaching Sudarshan Kriya Yoga (SKY) breathing techniques and Sahaj meditation, delivered online, combining group workshops, guided practice, and home exercises, monitored with wearable devices. | An online health education program covering general wellness topics, delivered through group sessions, with regular home practice and use of wearable monitoring, but without mind-body or yogic breathing components. |
| Role in the trial | Randomized experimental arm to assess the impact of mind-body and meditation practices on clinician stress and burnout. | Randomized active comparator arm to control for effects of health-oriented group training and daily practice. |
| Primary intended use | Reducing work-related burnout and stress among clinicians by teaching structured breathing and meditation. | Reducing clinician burnout and stress by providing structured health information, wellness guidance, and daily practice activities. |
| How is it given or performed? | Initial one-week onboarding including a 3-day (3.5 hours/day) live online workshop, followed by four weeks of weekly one-hour online sessions, and daily home practice of 45 minutes, monitored with an Oura Ring. | Initial one-week onboarding with a 2-day (3 hours/day) live online session, followed by four weeks of weekly two-hour online sessions, and daily home practice of 45 minutes, monitored with an Oura Ring. |
| Evidence status (published studies) | SKY and related yogic breathing programs have been evaluated in randomized trials for stress, depression, and burnout in diverse settings; studies in clinicians and healthcare workers show improvements in psychological well-being and reductions in burnout symptoms. However, large-scale effectiveness specifically in clinicians remains under investigation. | General health education and wellness workshops can modestly reduce burnout or distress among clinicians, but published trials suggest the effect is generally less substantial than that achieved with targeted mindfulness or mind-body programs. |
| Important study or program limitations | Requires daily home practice and routine online check-ins, which may not be compatible with all clinicians' schedules. Individual motivation and adherence can affect program impact. Evidence for long-term sustained benefits is still emerging. | Provides structured health information but does not include specific mind-body or meditation techniques. Limited evidence for strong and lasting reductions in burnout compared to specialized mindfulness approaches. Effectiveness may depend on engagement and baseline motivation. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (online or in-person)
Duration - 1 week
Participants wear an Oura Ring to collect baseline heart rate variability and sleep metric data.
Daily data collection via Oura Ring
Duration - 5 weeks
Participants engage in either the SKY program involving online workshops, weekly follow-up sessions, and daily practice, or the Health Education Program with online workshops, weekly follow-up sessions, and daily practice.
3-day onboarding workshops and weekly follow-up sessions online; daily practice at home; continuous Oura Ring monitoring
Duration - 2 weeks
Participants complete well-being and burnout questionnaires at midpoint (week 4) and endpoint (week 6) to evaluate the impact of the programs.
Assessments at Week 4 and Week 6 (online surveys)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34366134/Lancaster General Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborating Sponsor