A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR

Recruiting

• Conditions: Pain
• Interventions: Device: Pain key group

• Registration Number: NCT06290011
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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 clinically diagnosed with chronic moderate to severe pain

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 reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.

Study Timeline

• Study Start: 2023-10-11
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-06-11
• Study Completion: 2025-06-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. 18-85 years old male and female;
2. Patients clinically diagnosed with chronic pain;
3. Chronic pain lasts for more than 3 months;
4. The average intensity of pain in the past month is 40mm and above (VAS);
5. Willing to abide by the relevant regulations of the experiment;

Exclusion Criteria

1. Serious cognitive impairment;
2. Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
3. Symptoms of nausea or dizziness;
4. Sensitive to luminous screens;
5. No stereo vision or severe hearing impairment;
6. Eye, face or neck injuries, which hinder the comfortable use of glasses;
7. The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
8. Have used VR or MR and other related devices to treat pain;
9. Other clinical studies have been completed now or recently (the past 2 months);
10. Currently pregnant or planning to get pregnant during the study;
11. At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pain key group	Pain key group	mixed real pain treatment software, pain treatment scenarios in MR

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale/Score（VAS）	3 days	VAS pain score criteria ((0-10 points) 0 Points: painless; 3 points below: have a slight pain, can tolerate; 4 points- -6 points: patients with pain and affect sleep, and can still tolerate; 7 points-10 points: the patient has gradually intense pain, the pain is unbearable, affect appetite, affect sleep.

Trial Locations

Locations (1)

Ke Ma; 🇨🇳 Shanghai, Yangpu, China