Using virtual reality to help manage moderate to severe pain

Effects of Virtual Reality (VR) Based Distraction and Relaxation Therapy on Moderate and Severe Pain

This study is testing if virtual reality therapy can help adults with moderate to severe pain feel better when used alongside their usual treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05157893 on ClinicalTrials.gov

What this trial studies

This pilot study investigates the effectiveness of virtual reality (VR) based distraction and relaxation therapy as an additional pain relief method for patients experiencing moderate to severe pain. Participants will receive a 15-minute VR therapy session to assess its impact on pain levels and overall safety. The study is conducted at a single center in Shanghai, focusing on Chinese-speaking adults who meet specific pain criteria. The goal is to explore a novel approach to pain management that could complement existing treatments.

Who should consider this trial

Good fit: Ideal candidates are Chinese-speaking adults aged 18 and older with moderate to severe pain levels.

Not a fit: Patients with conditions that impair the use of VR technology or those with severe cognitive or sensory impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-pharmacological option for patients to manage their pain more effectively.

How similar studies have performed: While the use of VR for pain management is gaining interest, this specific approach is still considered novel and has not been extensively tested in similar studies.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Shanghai

• Shanghai XINHUA Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Ke Ma, PhD

Conditions Pain; pain; virtual reality; distraction therapy; relaxation therapy