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

NCT03681743 | Unknown

• 1 other identifier: H18-01150
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain measured using the Faces Pain Scale - Revised.

  Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.

  Pain is reported by children immediately following completion of the minor plastic surgery procedure

Secondary Outcomes (5)

• Anxiety using the Venham Situational Anxiety Score

  Anxiety is reported by children immediately following completion of the minor plastic surgery procedure

• Patient Satisfaction determined by Global Rating Scale

  Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure

• Medication Dose

  These will be recorded during the procedure and immediately following the procedure using the patient chart

• Timing

  Documented immediately after patient and family given discharge instructions

• Patient Use of Virtual Reality in the Future by Yes/No Question

  Reported by children immediately following completion of the minor plastic surgery procedure

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Device: Virtual Reality

Control (Standard-of-Care)

NO INTERVENTION

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

Interventions

Virtual Reality 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.

Virtual Reality

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Foundation: collaborator
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Ran D Goldman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran D Goldman, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: September 24, 2018
• Study Start: May 16, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)