Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children

NCT03693469 | Unknown

• 1 other identifier: H18-01851
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

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

Secondary Outcomes (4)

• Anxiety using the Venham Situational Anxiety Score

  Anxiety 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.

• Patient Satisfaction determined by Global Rating Scale

  Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization)

• Medication Dose

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

• Length of time of procedure

  This will be documented during the procedure

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

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 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 16 years
• Patients arriving to the immunization clinic for immunization.
• 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
• VR system may interfere with immunization

Sponsors & Collaborators

• University of British Columbia: lead

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 Goldman, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ran 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: September 20, 2018
• First Posted: October 3, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 18, 2019

Record last verified: 2019-01

Locations

CA (1)