Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2019-05-01

Brief Summary

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Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently 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 in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.

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Detailed Description

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Conditions

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Intravenous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality

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

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

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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

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Inclusion Criteria

* Children age 6 - \<17
* The managing physician determines a need for an intravenous catheterization (IV) procedure
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)
* Triage Category 1 (resuscitation)
* 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

Responsible Party

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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