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:

  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.

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Ke Ma

Shanghai, Yangpu, China, 200092

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