PainNCT05157893
Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain
A study testing Virtual reality based analgesic therapy in people with Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a prospective, single-arm, open, single-center clinical study. This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with moderate to severe pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Virtual reality based analgesic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥18 years old.
- Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
- Be able to communicate in Chinese.
- Be able to read and write Chinese.
- Willing to comply with study procedures and restrictions.
- Willing and able to sign informed consent.
Who cannot join
- Shingles on the eyes, ears, head, face, or hands.
- Trigeminal neuralgia.
- Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
- Severe hearing impairment.
- Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction, cholecystitis, etc.
- History of severe motion sickness.
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- Injury to eyes, ears, face, or neck that impedes comfortable use of virtual reality.
- Injury or dysfunction of hands or upper limbs that impedes comfortable use of virtual reality.
- Diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of virtual reality.
- History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc.
- Females currently pregnant.
- Current or completion of participation within 4 weeks before screening in any interventional clinical study
- Patients whom the investigator considers not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai XINHUA Hospital
Shanghai
Ke Ma, PhD, 86-21-25078707, marke72@163.com
Ke Ma, PhD
About this study
This is a prospective, single-arm, open, single-center clinical study. This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with moderate to severe pain. After screening, patients with moderate to severe pain who meet the study inclusion criteria receive VR therapy for 15 minutes to evaluate the effectiveness and safety of VR therapy.
- Conditions
- Pain
- Being tested
- Virtual reality based analgesic therapy
- Keywords
- pain, virtual reality, distraction therapy, relaxation therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based analgesic therapyDevice
The intervention is a single 15 min VR therapy. The VR therapy is consisted of VR device and software. The model of VR device used is Pico Neo 3 Pro. The software run on the VR device delivers two types of contents: 1) A 7min of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8min guided relaxation in which patients are transported to seaside with narrative to achieve image and breathing relaxation.
| Study group | Role | What they receive |
|---|---|---|
| VR analgesic therapy | Experimental | Patients receive a single VR therapy lasting 15 min. Receives: Device: Virtual reality based analgesic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity before and after VR therapy
The pain intensity is measured using a 0-10 numerical rating scale (NRS) of pain. The anchors for the numerical rating scale were "Ten is the worst pain anyone could ever have and zero is no pain at all." Before the VR therapy started, the participant would be asked what his or her pain level is on the 0-10 numerical rating scale. After the 15 minute VR therapy, the participant would be asked what his or her pain level at that moment, again using the 0-10 numerical rating scale. The change in pain intensity before and after VR therapy is then obtained with the two pain level numbers subtracted.
Measured: 20min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Dec 2021
- Primary completion21 Jun 2025 (estimated)
- Study completion21 Dec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157893
- Sponsor's protocol ID
- XH-21-011
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2021
- Last updated
- 13 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain
- ClinicalTrials.gov ID
- NCT05157893
- Acronym / sponsor ID
- XH-21-011
- Conditions
- Pain
- Keywords
- pain, virtual reality, distraction therapy, relaxation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 21 Jun 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 15 Dec 2021 (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.
This is a prospective, single-arm, open, single-center clinical study. This study is a pilot study to explore the use of VR based distraction and relaxation therapy as an adjunctive analgesic method for Chinese patients with moderate to severe pain. After screening, patients with moderate to severe pain who meet the study inclusion criteria receive VR therapy for 15 minutes to evaluate the effectiveness and safety of VR therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VR analgesic therapy | Experimental | Device: Virtual reality based analgesic therapyPatients receive a single VR therapy lasting 15 min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females ≥18 years old.
- Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours.
- Be able to communicate in Chinese.
- Be able to read and write Chinese.
- Willing to comply with study procedures and restrictions.
Key exclusion criteria (13 listed)
- Shingles on the eyes, ears, head, face, or hands.
- Trigeminal neuralgia.
- Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed)
- Severe hearing impairment.
- Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction, cholecystitis, etc.
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 |
|---|---|---|
| Virtual reality based analgesic therapyThe intervention is a single 15 min VR therapy. The VR therapy is consisted of VR device and software. The model of VR device used is Pico Neo 3 Pro. The software run on the VR device delivers two types of contents: 1) A 7min of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8min guided relaxation in which patients are transported to seaside with narrative to achieve image and breathing relaxation. | Device | VR analgesic therapy |
Primary outcome
Change in pain intensity before and after VR therapy
Time frame: 20min
The pain intensity is measured using a 0-10 numerical rating scale (NRS) of pain. The anchors for the numerical rating scale were "Ten is the worst pain anyone could ever have and zero is no pain at all." Before the VR therapy started, the participant would be asked what his or her pain level is on the 0-10 numerical rating scale. After the 15 minute VR therapy, the participant would be asked what his or her pain level at that moment, again using the 0-10 numerical rating scale. The change in pain intensity before and after VR therapy is then obtained with the two pain level numbers subtracted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based analgesic therapy in people with 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 6 inclusion and 13 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Ma, PhD (86-21-25078707, marke72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity before and after VR therapy (time frame: 20min). 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.