Recruiting

Virtual Reality vs. Standard-of-Care

Sponsor:

University of British Columbia

Code:

NCT03681730

Conditions

Intravenous Catheterization

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

Brief summary:

Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used.

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 topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.

Conditions

Intravenous Catheterization

Study ID

NCT03681730

Start date

May 2, 2018

Status verified date

Sep, 2018

Completion date

May 1, 2019

Anticipated

Primary completion date

May 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children age 6 - <17
  • The managing physician determines a need for an intravenous catheterization (IV) 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, autism, others)
  • Triage Category 1 (resuscitation)
  • Facial features or injury prohibiting wearing the VR goggles

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, nurses, nurse practitioners, child life specialists 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 using the Faces Pain Scale - Revised. [ Time Frame: Pain is reported by children immediately following completion of the IV start ]

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.