Virtual Reality to Reduce Pre-Operative Anxiety

Summary

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing various procedures in the Ambulatory Surgery Center (ASC) at CHLA, as measured by self- and proxy-report.

Conditions

• Virtual Reality
• Augmented Reality
• IV Stick
• Mask Induction
• Ambulatory Surgery
• Pain
• Anxiety

Interventions

DEVICE

Oculus Go VR

The Oculus Go is a standalone headset with built-in speakers that runs independently of a smartphone. Via the Oculus Go, participants will engage with BearBlast (developed by AppliedVR). Throughout the world, plush moles play the role of antagonist, standing in for the nuisance and distraction of pain. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. The VR HMD runs independently of a smartphone and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.

DEVICE

Mira Prism VR

The Mira Prism is a portable, augmented reality (AR) HMD powered by iPhone. When paired with the iPhone, the Mira Prism goggles can superimpose computer-generated images on the user's view of the real world. Unlike the full immersion of VR, AR allows users to view the outside world while interacting with digital content. In this study, the patient will interact with Magic Mallet (developed by Miney Moe) until falling asleep during the anesthesia induction process. Magic Mallet is a distraction game designed for pain management and communication during procedures. The game automatically adjusts cognitive load for optimal effect for users. Study team iPhones specifically loaded with Magic Mallet, and without cellular capability, will be used with the Mira Prism.

Sponsors & Collaborators

• AppliedVR Inc.

  collaborator INDUSTRY

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Jeffrey I Gold, PhD · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-12-04

Primary Completion

2026-12-06

Completion

2026-12-06

FDA Device

Yes

Countries

• United States

Study Locations