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

NCT ID: NCT03693469

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-10-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual Reality

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

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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.

Control (Standard-of-Care)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ran Goldman

Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ran Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ran Goldman, MD

Role: CONTACT

rgoldman@cw.bc.ca

604-875-2345 ext. 7333

Facility Contacts

Ran D Goldman, MD

Role: primary

rgoldman@cw.bc.ca

604-875-2000

Other Identifiers

H18-01851

Identifier Type: -

Identifier Source: org_study_id