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NCT Number: NCT06290011

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

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

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain key group

Device

mixed real pain treatment software, pain treatment scenarios in MR

Primary outcomes

  1. Visual Analogue Scale/Score(VAS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jingting Chen, phd

CONTACT

[email protected]

13122778387

Ke NA Ma, phd

CONTACT

[email protected]

13361879260

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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