Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children

NCT ID: NCT03681743

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-16
• Study Completion Date: 2019-05-09

Brief Summary

Children often experience pain and anxiety during minor medical procedures. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during minor painful procedure in the Plastic Surgery clinic. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.

Conditions

Minor Plastic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.

Control (Standard-of-Care)

Participants are distracted with Standard-of-Care by doctors and/or parents.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality

Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children age 6 to < 17 years
• Patients scheduled for minor elective plastic surgery procedure
• Parents will sign a consent form and children will sign an assent form

Exclusion Criteria

• Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
• Facial features or injury prohibiting wearing the VR goggles
• Procedure in the face, where the VR system may interfere with Plastic Surgeon work

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BC Children's Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

BC Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ran Goldman

Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ran D Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ran D Goldman, MD

Role: CONTACT

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Facility Contacts

Ran D Goldman, MD

Role: primary

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Other Identifiers

H18-01150

Identifier Type: -

Identifier Source: org_study_id