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Behavioral Intervention

Single Arm Study for Chronic Pain

Phase 1 & 2
Recruiting
Led By Linda Larkey, PhD
Research Sponsored by Arizona State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4, 8 and 12 weeks
Awards & highlights

Study Summary

This trial tests an app to help reduce pain, pain stress, and fear of movement in older adults with knee osteoarthritis and chronic pain. Participants use an app twice daily for 8 weeks and complete surveys.

Who is the study for?
This trial is for English-speaking adults with knee osteoarthritis who've had pain for at least 3 months and are afraid of movement. They must have a smartphone, score high on the fear of movement scale, and commit to an 8-week study with follow-up calls. It's not suitable for those with motion sickness, respiratory diseases, heart issues, certain mental illnesses or taking specific medications.Check my eligibility
What is being tested?
The study tests a phone app that combines virtual reality nature scenes with biofeedback to manage pain and anxiety in older adults with knee osteoarthritis. Participants will use the app twice daily for eight weeks and answer surveys about their experience and any changes in their condition.See study design
What are the potential side effects?
Since this intervention uses non-invasive technology like a phone application combined with virtual reality scenes, side effects may be minimal but could include discomfort from prolonged screen time or emotional distress if the content triggers unexpected reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4, 8 and 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4, 8 and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence Measure
Satisfaction Measure
Secondary outcome measures
Brief Fear of Movement scale adapted from the Tampa Scale of Kinesiophobia 11 (TSK-11)
Customized Technology Adoption Survey
Heart Rate
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm StudyExperimental Treatment1 Intervention
All participants will receive access to the phone application with a virtual reality headset and heart rate variability Bluetooth ear sensor. Participants will be instructed to download a free phone app Elite Heart Rate Variability, login using study provided de-identified research email address, pair the Bluetooth ear sensor and record a five-minute resting heart rate variability reading at baseline and each time point of the study prior to beginning intervention. Participants will be asked to use the intervention phone application for 7-10 minute sessions twice daily 5 days a week for 8 weeks. For the first 8 weeks, participants will receive brief, daily texts encouraging participation in the smart phone application. During weeks 9 through 12, will receive relaxation reminders daily via text to determine if use is sustained past the intervention phase

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Who is running the clinical trial?

Arizona State UniversityLead Sponsor
283 Previous Clinical Trials
109,490 Total Patients Enrolled
1 Trials studying Chronic Pain
4,025 Patients Enrolled for Chronic Pain
Linda Larkey, PhDPrincipal InvestigatorArizona State University
2 Previous Clinical Trials
254 Total Patients Enrolled

Media Library

Virtual Reality Nature scene plus heart rate variability biofeedback phone application (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05721352 — Phase 1 & 2
Chronic Pain Research Study Groups: Single Arm Study
Chronic Pain Clinical Trial 2023: Virtual Reality Nature scene plus heart rate variability biofeedback phone application Highlights & Side Effects. Trial Name: NCT05721352 — Phase 1 & 2
Virtual Reality Nature scene plus heart rate variability biofeedback phone application (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721352 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential participants in this clinical investigation?

"This medical trial is open to enrolment, as indicated on clinicaltrials.gov. The study was launched on September 15th 2022 and its details have been most recently revised on February 8th 2023."

Answered by AI

Do seniors above the age of 35 qualify for this medical investigation?

"To qualify, the patient must be between 45 and 74 years old. The trial has 60 studies for minors and 773 for seniors."

Answered by AI

May I join this experiment as a participant?

"Candidates aged 45-74 who suffer from chronic pain may qualify for this research study, which is looking to enrol 24 participants."

Answered by AI

What is the cap on enrolment for this research trial?

"Affirmative. Data available on clinicaltrials.gov confirms that this trial, which was initially posted to the site on September 15th 2022, is actively seeking participants. 24 individuals are needed for enrollment and will be recruited from one medical centre."

Answered by AI

What is the primary objective of this research endeavor?

"This 8-week long trial seeks to gauge patient satisfaction. Secondary assessments will encompass the Multidimensional Assessment of Somatic Sense Scale, consisting of 8 domains (32 items) assessing body awareness and self regulation. The scoring range for each domain is 0-5, with higher values indicating better results; this scale has a minimum score of 0 and maximum value dependent on number of questions answered. Additionally, heart rate and vagal tone data will be collected pre/post intervention for further analysis."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
Texas
What site did they apply to?
Arizona State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Arthritis Ease Study
Linda Larkey 2022. "Arthritis Ease Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721352.
~3 spots leftby Aug 2024
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