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NCT04632368 · ClinicalTrials.gov registry record · NA
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
A NA study of Stress, Psychological and Burnout, Professional, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT04632368: Completed NA study of Stress, Psychological and Burnout, Professional, sponsored by Duke University.
NCT04632368 is a NA study of Stress, Psychological and Burnout, Professional that has completed, run by Duke University. The registered enrollment target is 80 participants, below the 170-participant average among 43 other Stress, Psychological trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632368, a NA study of Stress, Psychological and Burnout, Professional, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Changes in brief symptom inventory as evaluated by BSI 18
Conditions Studied
Interventions
- BEHAVIORAL Transcendental Meditation
Study Locations (1)
North Carolina
- Duke University health system - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2021-08-16 |
| Phase | NA |
What the finished NCT04632368 record still lists
NCT04632368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 170-participant average among 43 other Stress, Psychological trials with a reported enrollment target (53% lower).
The record links to 2 conditions, with Stress, Psychological appearing as the primary indexed condition, and to 1 intervention - of which Transcendental Meditation is the first listed.
NCT04632368 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04632368 about?
NCT04632368 is a clinical study titled "Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic". 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 ...
What is the current status of trial NCT04632368?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2020-11-20. Estimated completion is 2021-08-16.
What conditions does trial NCT04632368 study?
This clinical trial studies the following conditions: Stress, Psychological, Burnout, Professional.
What interventions are being tested in trial NCT04632368?
The interventions under investigation include: Transcendental Meditation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04632368?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04632368 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04632368's enrollment target sits among peer trials
80 24th of 43 higher than 20 of 43 other Stress, Psychological trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress, Psychological trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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