Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

NCT ID: NCT03692390

Last Updated: 2018-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-21
• Study Completion Date: 2019-09-21

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 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 while undergoing procedural sedation

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.

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. 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

• 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@bc.cw.ca

(604) 875-2346 ext. 7333

Other Identifiers

H18-01949

Identifier Type: -

Identifier Source: org_study_id