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

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

Recruiting
18-85 years
All
Phase N/A

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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

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.

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 details
    Pain

NCT06290011

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

21 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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