Recruiting

Virtual Reality vs. Standard-of-Care

Sponsor:

University of British Columbia

Code:

NCT03693469

Conditions

Vaccination

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

Brief summary:

Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly 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 while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.

Conditions

Vaccination

Study ID

NCT03693469

Start date

Oct 1, 2018

Status verified date

Jan, 2019

Completion date

Oct 1, 2019

Anticipated

Primary completion date

Oct 1, 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. Patients arriving to the immunization clinic for immunization.
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)
2. Facial features or injury prohibiting wearing the VR goggles
3. VR system may interfere with immunization

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 immunization.

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 immunization (within two minutes post-immunization). This scale should take less than one minute to complete. ]

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

604-875-2000rgoldman@cw.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jan 18, 2019

Last verified

Jan, 2019

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 2019-01-18.