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NCT03975075 · ClinicalTrials.gov registry record · NA
Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
A NA study, sponsored by Craig Hospital.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT03975075 is a NA study that has completed, run by Craig Hospital. The registered enrollment target is 30 participants.
The verdict
NCT03975075, a NA study, has completed, sponsored by Craig Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 20 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session. It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.
Interventions
- BEHAVIORAL Biofeedback training
- BEHAVIORAL Psychophysiological monitoring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2023-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03975075
The ClinicalTrials.gov registry entry for NCT03975075 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Craig Hospital, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Biofeedback training is the first listed.
NCT03975075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03975075 about?
NCT03975075 is a clinical study titled "Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury". The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia. The expected duration of participation in this study is about 5 hours over the course of about 5 weeks. Participants will be randomly assigned...
What is the current status of trial NCT03975075?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2019-10-01. Estimated completion is 2023-01-31.
What interventions are being tested in trial NCT03975075?
The interventions under investigation include: Biofeedback training (BEHAVIORAL), Psychophysiological monitoring (BEHAVIORAL).
Who is sponsoring clinical trial NCT03975075?
This trial is sponsored by Craig Hospital, which has 29 total clinical trials registered on ClinicalTrials.gov.
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