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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290011
• Other study ID #: XH-23-014
• Status: Recruiting
• Start date: October 11, 2023
• Est. completion date: October 11, 2024

Study information

• Verified date: October 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ke NA Ma, phd
• Phone: 13361879260
• Email: marke72[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: October 11, 2024
• Est. primary completion date: October 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• Pain key group
mixed real pain treatment software, pain treatment scenarios in MR

Locations

Country	Name	City	State
China	Ke Ma	Shanghai	Yangpu

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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