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NCT04632368
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
NA trial testing Transcendental Meditation in Burnout, Professional in 80 participants. Completed in 16 August 2021.
10 August 2021
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 80 |
| Start date | 20 November 2020 |
| Primary completion | 10 August 2021 |
| Estimated completion | 16 August 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcendental Meditation
Conditions studied
- Burnout, Professional — all drugs for Burnout, Professional →
- Stress, Psychological — all drugs for Stress, Psychological →
Sponsor
Duke University
Who can join
18 and older, any sex, with Burnout, Professional or Stress, Psychological. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04632368
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- NCT04821505 — Stress Reduction and Hypertension Prevention in African Americans · Phase 2 · completed
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Other Duke University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04632368 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 23 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04632368.
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