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

University of British Columbia

Status: Unknown

Conditions: Procedural Sedation

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03692390

H18-01949

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Virtual Reality

Experimental group

Description:

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

Treatment:

Device: Virtual Reality

Standard-of-Care

No Intervention group

Description:

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