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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06290011
Other study ID # XH-23-014
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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