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

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Device: Virtual reality based analgesic therapy

• Registration Number: NCT05157893
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-30
• Study Start: 2021-12-01
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-15
• Status Verified: 2023-12
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2025-06-21
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VR analgesic therapy	Virtual reality based analgesic therapy	Patients receive a single VR therapy lasting 15 min.

Primary Outcome Measures

Name	Time	Method
Change in pain intensity before and after VR therapy	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.

Trial Locations

Locations (1)

Shanghai XINHUA Hospital; 🇨🇳 Shanghai, China