Pain
Conditions
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
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.
Interventions
DEVICEPain key group
mixed real pain treatment software, pain treatment scenarios in MR
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale/Score（VAS） | 3 days | 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. |
Countries
China
Contacts
Primary ContactKe NA Ma, phd
Backup ContactJingting Chen, phd
Outcome results
None listed