Status:
RECRUITING
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
Lead Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Pain
Eligibility:
All Genders
18-85 years
Brief Summary
A prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of MR based "cognitive distraction focus relaxation therapy" in patients cl...
Detailed Description
Multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on MR mixed reali...
Eligibility Criteria
Inclusion Criteria:
- 18-85 years old male and female;
- Patients clinically diagnosed with chronic pain;
- Chronic pain lasts for more than 3 months;
- The average intensity of pain in the past month is 40mm and above (VAS);
- Willing to abide by the relevant regulations of the experiment;
Exclusion Criteria:
- Serious cognitive impairment;
- Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
- Symptoms of nausea or dizziness;
- Sensitive to luminous screens;
- No stereo vision or severe hearing impairment;
- Eye, face or neck injuries, which hinder the comfortable use of glasses;
- The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
- Have used VR or MR and other related devices to treat pain;
- Other clinical studies have been completed now or recently (the past 2 months);
- Currently pregnant or planning to get pregnant during the study;
- At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.
Key Trial Info
Start Date :
October 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 11 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06290011
Start Date
October 11 2023
End Date
June 11 2025
Last Update
November 13 2024
Active Locations (1)
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1
Ke Ma
Shanghai, Yangpu, China, 200092