Virtual Reality vs Passive Distraction for Pain Management

Summary

Background: Outpatient pediatric orthopedic procedures such as percutaneous pins removal and sutures are considered painful and generate significant stress and anxiety in children. However, given their short duration and the need for a quick turnover in outpatient clinics, there are very few interventions aimed at relieving pain, stress and anxiety related to these procedures. Neither simple analgesia nor topical anesthetics proved effective for procedural pain reduction with this population. Moreover, narcotics and procedural sedation do not appear to be feasible alternatives as they require surveillance, prolonging visit to the outpatient clinic and generating several undesired side effects. Therefore, it would be imperative to explore non-pharmacological pain management methods as they require minimal preparation and do not usually generate any side effects.

Aim: To examine the effect of virtual reality (VR) compared to passive distraction, on pain, stress, anxiety and memory of pain in children undergoing a percutaneous pin removal procedure or sutures in an outpatient orthopedic clinic.

Hypothesis: VR distraction provides better pain relief during percutaneous pin removal procedures or sutures than passive distraction, in children from 7 to 21 years old.

Methods: The study will be a prospective randomized controlled trial with parallel groups. Children from 7 to 21 years old, visiting the clinic for follow up and percutaneous pin removal procedure or sutures, accompanied by a parent or legal guardian will be recruited. The experimental group will receive a VR distraction through a head-mounted Oculus Quest® and the control group will receive passive distraction through watching a video on an iPad®. The primary outcome will be the mean pain score after the procedure (self-report of pain level during the procedure) measured by the Numerical Rating Scale (NRS). Anxiety will be measured by the Child Fear Scale (CFS) and stress will be measured using level of salivary Alpha-Amylase before and 10-min after the procedure. Memories of pain and anxiety will be measured one week after the procedure using the same scales (NRS and CFS). The investigators aim to recruit 188 children.

Discussion: The investigators believe that results of this study will allow to improve pain, stress and anxiety management practices in this orthopedic clinic by showing that non-pharmacological interventions can be done, at very low cost, to improve the experience of the child undergoing these painful procedures through an innovative and more humanistic approach.

Conditions

• Virtual Reality
• Pain
• Pain Perception
• Pain Management
• Anxiety
• Catastrophizing, Pain
• Stress

Interventions

DEVICE

Passive Distraction

Patients in this group will be offered an iPad® showing a video while they will undergo their pins' removal and/or removal of sutures. There will be videos appropriate for each age group. The child can choose from the videos presented on the iPad® and start watching 5 minutes before the beginning of the procedure to assure similar preparation for both groups.

DEVICE

Virtual Reality Distraction

Patients in this group will be offered virtual reality distraction through the use of Oculus Quest® while they undergo their pins' removal and/or removal of sutures. VR produces a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness symptoms such as nausea, vomiting, headache. The videogame was developed by our team with three levels of difficulty, and approved by pediatric healthcare professionals. The game, oculus head-mounted device and computer will be available in the procedure room and ready for immediate use. The head-mounted device will be adjusted to the head of the child before any procedure and a period of 5 minutes will be allotted prior to pin and/or suture removal in order for the child to get acquainted with the game and immersed in the virtual environment.

Sponsors & Collaborators

• Montreal Children's Hospital of the MUHC

  collaborator OTHER

• Shriners Hospitals for Children

  collaborator OTHER

• St. Justine's Hospital

  lead OTHER

Principal Investigators

• Sylvie Le May, PhD · St. Justine's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-14

Primary Completion

2022-10-14

Completion

2022-10-25

Countries

• Canada

Study Locations