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

NCT03692390 | Unknown

• 1 other identifier: H18-01949
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual Reality; Heart Rate; Blood Pressure

Outcome Measures

Primary Outcomes (2)

• Change in Heart Rate as measured by heart rate monitor

  The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups.

  During the procedure at 1 minute intervals

• Change in Blood Pressure as measured by blood pressure monitor

  The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups.

  During the procedure at 1 minute intervals

Secondary Outcomes (7)

• Emergence Phenomenon as measured by yes/no questions regarding participant experience.

  Immediately after the procedure and by phone the next day

• Satisfaction among Children by global rating scale

  Immediately after the procedure

• Satisfaction among Guardians by global rating scale

  Immediately after the procedure

• Satisfaction among Emergency Staff by global rating scale

  Immediately after the procedure

• Type and dose of medication

  Intraoperative

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation

Device: Virtual Reality

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
• The managing physician determines need for procedural sedation
• 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, autism, inability to communicate)
• Triage category 1 (resuscitation)
• Facial features or injury prohibiting wearing the VR goggles

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

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 2, 2018
• Study Start: September 21, 2018
• Primary Completion: September 21, 2019
• Study Completion: September 21, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

CA (1)