Recruiting

Virtual Reality vs. Standard-of-Care

Sponsor:

University of British Columbia

Code:

NCT03681743

Conditions

Minor Plastic Surgery

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

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 ID

NCT03681743

Start date

May 16, 2018

Status verified date

Sep, 2018

Completion date

May 9, 2019

Anticipated

Primary completion date

May 9, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Virtual Reality

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

no intervention: Control (Standard-of-Care)

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

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.

Primary outcome measure

  • Pain measured using the Faces Pain Scale - Revised. [ Time Frame: Pain is reported by children immediately following completion of the minor plastic surgery procedure ]

Central Contacts and Locations

Central contacts

Ran D Goldman, MD

604-875-2345rgoldman@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Ran D Goldman, MD

604-875-2345rgoldman@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Sep 24, 2018

Last verified

Sep, 2018

Keywords

  • Virtual Reality
  • Pain
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-09-24.