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NCT05721352 · ClinicalTrials.gov registry record · Phase 1
Arthritis Ease Study
A Phase 1 study, sponsored by Arizona State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT05721352 is a Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 36 participants.
The verdict
NCT05721352, a Phase 1 study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to test using a pain and anxiety reduction phone application in older adults with knee osteoarthritis and chronic pain. The main questions it seeks to answer are: 1. How acceptable is using a phone app in older adults with knee osteoarthritis and chronic pain to lower pain, pain stress and reduce fear of movement? 2. What are the effects of combining biofeedback with a virtual reality nature scene and paced breath training to increase heart rate variability on pain and anxiety among older adults with knee osteoarthritis? 3. What is the role of self-regulation and body awareness in predicting or strengthening the effect of combining virtual reality, heart rate variability biofeedback in older adults with knee osteoarthritis?. Participants will be asked to: 1. use a phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks. 2. receive relaxation reminders weeks 9 through 12 to see if use continues past the intervention phase. 3. complete surveys describing pain, physical activity, fear of movement, body awareness and self-regulation, pain stress pre/post the app use. 4. complete a survey and interview after 8 weeks of phone app use to describe the experience of its use.
Interventions
- BEHAVIORAL Virtual Reality Nature scene plus heart rate variability biofeedback phone application
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-09-15 |
| Est. Completion | 2024-09-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05721352
The ClinicalTrials.gov registry entry for NCT05721352 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Virtual Reality Nature scene plus heart rate variability biofeedback phone application is the first listed.
NCT05721352 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05721352 about?
NCT05721352 is a clinical study titled "Arthritis Ease Study". The goal of this clinical trial is to test using a pain and anxiety reduction phone application in older adults with knee osteoarthritis and chronic pain. The main questions it seeks to answer are: 1. How acceptable is using a phone app in older adults with knee osteoarthritis and chronic pain to l...
What is the current status of trial NCT05721352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-09-15. Estimated completion is 2024-09-11.
What interventions are being tested in trial NCT05721352?
The interventions under investigation include: Virtual Reality Nature scene plus heart rate variability biofeedback phone application (BEHAVIORAL).
Who is sponsoring clinical trial NCT05721352?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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