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

University of British Columbia logo

University of British Columbia

Status

Unknown

Conditions

Minor Plastic Surgery

Treatments

Device: Virtual Reality

Study type

Interventional

Funder types

Other

Identifiers

NCT03681743
H18-01150

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

Virtual Reality
Experimental group
Description:
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.
Treatment:
Device: Virtual Reality
Control (Standard-of-Care)
No Intervention group
Description:
Participants are distracted with Standard-of-Care by doctors and/or parents.

Trial contacts and locations

1

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Central trial contact

Ran D Goldman, MD

Data sourced from clinicaltrials.gov

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