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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: Completed NA study, sponsored by Villanova University.
NCT04921228 is a NA study that has completed, run by Villanova University. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Measured by calculating the proportion of the people contacted who initially agree to participate in the study, defined as individuals who complete the baseline assessment following consent. This will assess feasibility to establish interest in HRV biofeedback among eligible participants from the CHAMPS registry.
Interventions
- BEHAVIORAL Heart rate variability biofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-11-08 |
| Est. Completion | 2022-04-10 |
| Phase | NA |
What the finished NCT04921228 record still lists
NCT04921228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Heart rate variability biofeedback is the first listed.
NCT04921228 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04921228's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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