Actively Recruiting
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR in the Treatment of Chronic Pain: a Multicenter, Randomized Controlled, Single Blind Clinical Study
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-13
132
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the analgesic effect and safety of a mixed reality (MR) based cognitive distraction focus relaxation therapy for patients diagnosed with chronic moderate to severe pain. This multicenter, prospective, single-blind, randomized, and parallel controlled trial aims to assess the impact of a digital chronic pain treatment system using MR technology as part of basic clinical care for chronic pain patients. Participants are assigned to one of two groups: the pain key group receiving mixed reality pain treatment software with MR-based pain scenarios, or a control group exposed to the same content displayed on a 2D TV screen. The study compares these approaches to understand the role of MR technology in managing chronic pain. During the study, participants will be monitored using the Visual Analogue Scale (VAS) to measure pain levels over three days. Researchers will collect data on pain intensity and safety outcomes while participants follow the treatment protocols. The trial runs from October 2023 to June 2025, involving adults aged 18 to 85 years with chronic pain lasting more than three months.
CONDITIONS
Brief Title
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18-85 years old male and female
- Patients clinically diagnosed with chronic pain
- Chronic pain lasting for more than 3 months
- Average pain intensity in the past month is 40mm or above on the Visual Analogue Scale
- Willing to follow the study regulations
You will not qualify if you...
- Serious cognitive impairment
- Current or previous diagnosis of epilepsy, dementia, migraine, or other neurological diseases that may affect mixed reality use
- Symptoms of nausea or dizziness
- Sensitivity to luminous screens
- No stereo vision or severe hearing impairment
- Eye, face, or neck injuries preventing comfortable use of glasses
- High scores on GAD-7 (10 or above) or PHQ-9 (10 or above) questionnaires
- Prior use of VR or MR devices for pain treatment
- Participation in other clinical studies currently or within the past 2 months
- Currently pregnant or planning pregnancy during the study
- Immediate family members working in digital health or pharmaceutical companies providing pain treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants undergo treatment with either the mixed reality pain treatment software or a 2D TV screen treatment as part of the study intervention.
Daily visits or sessions during the 3-day treatment period
Trial Site Locations
Total: 1 location
1
Ke Ma
Shanghai, Yangpu, China, 200092
Actively Recruiting
Research Team
K
Ke NA Ma, phd
J
Jingting Chen, phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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