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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: Completed Phase 1 study, sponsored by Arizona State University.
NCT05721352 is a Phase 1 study that has completed, run by Arizona State University. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The adherence benchmark will be 80% of participants will participate at least 5 days per week during the initial 8-week intervention period. Adherence will be examined (not benchmarked) during the 4-week follow-up period
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 |
What the finished NCT05721352 record still lists
NCT05721352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05721352's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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