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NCT04921228 · ClinicalTrials.gov registry record · NA

Biofeedback for CHAMPS

A NA study, sponsored by Villanova University.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT04921228 is a NA study that has completed, run by Villanova University. The registered enrollment target is 25 participants.

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The verdict

NCT04921228, a NA study, has completed, sponsored by Villanova University.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

As a result of the COVID-19 pandemic, the degree of burnout and consequential negative psychological effects experienced by healthcare providers has been substantially exacerbated. Heart rate variability (HRV) biofeedback has long been used to assist with a wide variety of stress-related concerns. Building on evidence that HRV biofeedback has the potential to improve wellbeing, the purpose of this study is to pilot test and determine the feasibility of implementing a digital HRV biofeedback tool to improve disordered eating, mindful self-care (i.e., self-compassion, body appreciation, etc.), and perceived stress in healthcare providers. In addition to assessing acceptability and feasibility of the HRV biofeedback tool, the investigators will aim to establish 'proof-of-concept' for a conceptual model consisting of potential psychological constructs underlying the mechanisms of change for the intervention-namely mind-body awareness (i.e., interoception) and resilience. Our primary recruitment pool will include healthcare providers who reported elevated eating distress as a participant in an ongoing observational study of the health effects of theCOVID-19 pandemic on essential workers (CHAMPS).

Interventions

  • BEHAVIORAL Heart rate variability biofeedback

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2021-11-08
Est. Completion 2022-04-10
Phase NA

Sponsor

Villanova University

8 total trials

What the Registry Record Tells You About NCT04921228

The ClinicalTrials.gov registry entry for NCT04921228 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Villanova University, which has 8 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Heart rate variability biofeedback is the first listed.

NCT04921228 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04921228 about?

NCT04921228 is a clinical study titled "Biofeedback for CHAMPS". As a result of the COVID-19 pandemic, the degree of burnout and consequential negative psychological effects experienced by healthcare providers has been substantially exacerbated. Heart rate variability (HRV) biofeedback has long been used to assist with a wide variety of stress-related concerns. B...

What is the current status of trial NCT04921228?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2021-11-08. Estimated completion is 2022-04-10.

What interventions are being tested in trial NCT04921228?

The interventions under investigation include: Heart rate variability biofeedback (BEHAVIORAL).

Who is sponsoring clinical trial NCT04921228?

This trial is sponsored by Villanova University, which has 8 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.