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

NCT06290011 | Recruiting

• 1 other identifier: XH-23-014
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Pain key group

mixed real pain treatment software, pain treatment scenarios in MR

Device: Pain key group

Sham MR group

TV screen 2D treatment scene with the same content provided

Interventions

Pain key group DEVICE

mixed real pain treatment software, pain treatment scenarios in MR

Pain key group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic pain lasts for more than 3 months;

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ke Ma

Shanghai, Yangpu, 200092, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ke NA Ma, phd

  studay chair

  STUDY CHAIR

Central Study Contacts

Ke NA Ma, phd

CONTACT

13361879260; marke72@163.com

Jingting Chen, phd

CONTACT

13122778387; 806041409@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: March 4, 2024
• Study Start: October 11, 2023
• Primary Completion: June 11, 2025
• Study Completion: June 11, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (1)