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

NCT ID: NCT05157893

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-21

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.

Conditions

Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR analgesic therapy

Patients receive a single VR therapy lasting 15 min.

Group Type: EXPERIMENTAL

Virtual reality based analgesic therapy

Intervention Type: DEVICE

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.

Interventions

Virtual reality based analgesic therapy

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai XINHUA Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ke Ma, PhD

Role: CONTACT

marke72@163.com

86-21-25078707

Facility Contacts

Ke Ma, PhD

Role: primary

marke72@163.com

86-21-25078707

Other Identifiers

XH-21-011

Identifier Type: -

Identifier Source: org_study_id