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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 45 Years - 74 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05721352 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Arizona State University |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Linda Larkey, PhD |
Principal Investigator Affiliation | Arizona State University |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Knee Osteoarthritis, Chronic Pain, Kinesiophobia |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.