Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair

NCT03681717 | Unknown

• 1 other identifier: H17-02711
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety. 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 pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.

Conditions

Laceration

Keywords

Virtual Reality; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• Pain 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 laceration repair

Secondary Outcomes (5)

• Anxiety using the Venham Situational Anxiety Score

  Anxiety is reported by children immediately following completion of the laceration repair

• Patient Satisfaction determined qualitatively by an open ended question

  Satisfaction question is reported by children immediately following completion of the laceration repair

• Parent Satisfaction determined qualitatively by an open ended question

  Satisfaction question is reported by parents immediately following completion of the laceration repair

• Medication Dose

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

• Timing

  Documented immediately after patient and family given discharge paperwork

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures.

Device: Virtual Reality

Control (Standard-of-Care)

NO INTERVENTION

Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.

Interventions

Virtual Reality DEVICE

Participants wear a Virtual Reality headset that consists of a ASUS phone and a ReTrack Utopia 360 VR 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 - \<17 years
• Arriving to the Emergency Department with a chief complaint of laceration
• The managing physician determines need for repair with suture
• 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)
• Triage category 1 (resuscitation)
• Facial features or injury prohibiting wearing VR goggles

Sponsors & Collaborators

• University of British Columbia: lead
• Doctors of BC: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Lacerations; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; 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: February 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)