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Arthritis Ease Study

NCT05721352 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-09-23

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

Virtual Reality Nature scene plus heart rate variability biofeedback phone application

phone app for slow- paced breath training with biofeedback in a virtual reality nature scene

Sponsors & Collaborators

  • Arizona State University

    lead OTHER

Principal Investigators

  • Linda Larkey, PhD · Arizona State University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2024-09-11
Completion
2024-09-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721352 on ClinicalTrials.gov