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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 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.

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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

Interventions

  • BEHAVIORAL Transcendental Meditation

Study Locations (1)

North Carolina

  • Duke University health system - Durham

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2020-11-20
Est. Completion 2021-08-16
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT04632368

The ClinicalTrials.gov registry entry for NCT04632368 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 43 other Stress, Psychological trials with a reported enrollment target (53% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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