Recruiting

Virtual Reality vs. Standard-of-Care

Sponsor:

University of British Columbia

Code:

NCT03692390

Conditions

Procedural Sedation

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

Brief summary:

Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).

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. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.

Conditions

Procedural Sedation

Study ID

NCT03692390

Start date

Sep 21, 2018

Status verified date

Sep, 2018

Completion date

Sep 21, 2019

Anticipated

Primary completion date

Sep 21, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

INCLUSION CRITERIA

1. Children age 6 to 16 years
2. The managing physician determines need for procedural sedation
3. Parents will sign a consent form and children will sign an assent form

EXCLUSION CRITERIA

1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate)
2. Triage category 1 (resuscitation)
3. 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 while undergoing procedural sedation

no intervention: 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

  • Change in Heart Rate as measured by heart rate monitor [ Time Frame: During the procedure at 1 minute intervals ]
  • Change in Blood Pressure as measured by blood pressure monitor [ Time Frame: During the procedure at 1 minute intervals ]

Central Contacts and Locations

Central contacts

Ran 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) 875-2346rgoldman@bc.cw.ca

More Information

Sponsor

University of British Columbia

Last update posted

Oct 2, 2018

Last verified

Sep, 2018

Keywords

  • Virtual Reality
  • Heart Rate
  • Blood Pressure

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 2018-10-02.