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

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Pain

Treatments

Device: Virtual reality based analgesic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05157893

XH-21-011

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.