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

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Device: Pain key group

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 Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Ke NA Ma, PHD; Phone Number: 13361879260; Email: marke72@163.com
• Study Contact Backup: Name: Jingting Chen, phd; Phone Number: 13122778387; Email: 806041409@qq.com

Study Locations

• China
  • Yangpu
    • Shanghai, Yangpu, China, 200092
      • Recruiting
      • Ke Ma
      • Contact: Ke NA Ma, PHD; Phone Number: 13361879260; Email: marke72@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chronic pain lasts for more than 3 months;

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pain key group; mixed real pain treatment software, pain treatment scenarios in MR	Device: Pain key group; mixed real pain treatment software, pain treatment scenarios in MR
Sham MR group; TV screen 2D treatment scene with the same content provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale/Score（VAS）	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.	3 days

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Ke NA Ma, phd, studay chair

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): June 11, 2025
• Study Completion (Estimated): June 11, 2025

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: XH-23-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No