- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290011
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
February 29, 2024 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
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
Study Overview
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.
Study Type
Observational
Enrollment (Estimated)
132
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ke NA Ma, PHD
- Phone Number: 13361879260
- Email: marke72@163.com
Study Contact Backup
- Name: jingting chen, phd
- Phone Number: 13122778387
- Email: 806041409@qq.com
Study Locations
-
-
Yangpu
-
Shanghai, Yangpu, China, 200092
- Recruiting
- Ke Ma
-
Contact:
- Ke NA Ma, PHD
- Phone Number: 13361879260
- Email: marke72@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Chronic pain lasts for more than 3 months;
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pain key group
mixed real pain treatment software, pain treatment scenarios in MR
|
mixed real pain treatment software, pain treatment scenarios in MR
|
Sham MR group
TV screen 2D treatment scene with the same content provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: ke na ma, phd, studay chair
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 11, 2023
Primary Completion (Estimated)
October 11, 2024
Study Completion (Estimated)
October 11, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
February 29, 2024
First Posted (Estimated)
March 4, 2024
Study Record Updates
Last Update Posted (Estimated)
March 4, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
October 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- XH-23-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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