PainNCT06290011
A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR
An observational study of Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- Pain key group
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2023to 11 Jun 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic pain lasts for more than 3 months;
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ke Ma
Shanghai, Yangpu, 200092
Ke NA Ma, PHD, 13361879260, marke72@163.com
About this study
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
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
Read the 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.
- Conditions
- Pain
- Being tested
- Pain key group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain key groupDevice
mixed real pain treatment software, pain treatment scenarios in MR
| Study group | Role | What they receive |
|---|---|---|
| Pain key group | mixed real pain treatment software, pain treatment scenarios in MR Receives: Device: Pain key group | |
| Sham MR group | TV screen 2D treatment scene with the same content provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale/Score（VAS）
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start11 Oct 2023
- Primary completion11 Jun 2025 (estimated)
- Study completion11 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 132 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke NA Ma, phd, Study chair, studay chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290011
- Sponsor's protocol ID
- XH-23-014
- Status last verified
- Nov 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06290011
- Acronym / sponsor ID
- XH-23-014
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 11 Jun 2025 (estimated)
- Study completion
- 11 Jun 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain key group | – | Device: Pain key groupmixed real pain treatment software, pain treatment scenarios in MR |
| Sham MR group | – | –TV screen 2D treatment scene with the same content provided |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic pain lasts for more than 3 months;
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain key groupmixed real pain treatment software, pain treatment scenarios in MR | Device | Pain key group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ke NA Ma, phd study chair
studay chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ke NA Ma, phd (13361879260, marke72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale/Score（VAS） (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.