A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pain key group.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device Pain key group
mixed real pain treatment software, pain treatment scenarios in MR
Primary outcome measures
- Visual Analogue Scale/Score（VAS） [Time frame: 3 days]
Eligibility criteria
Inclusion criteria
- 18-85 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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Ke Ma — Shanghai
Identifiers
NCT: NCT06290011 · XH-23-014