Virtual Reality vs Passive Distraction for Pain Management

NCT03680625 | Completed

• 1 other identifier: 2019-2030
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Virtual reality; Immersive distraction; Virtual world; Virtual environment; Passive distraction; Procedural pain; Procedural anxiety; Acute pain; Pain management; Anxiety; Children, Child; Kid, Kids; Pediatric, Pediatrics; Young children; Orthopedics; Kirschner wire, K pin; Bone wires; Percutaneous pins; Non-pharmacological; Clinical Research; Nursing Practice; User-computer interface; Pediatric Nursing; Hospital, Pediatric; Sutures; Stress

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  self-report of pain level during the procedure assessed using the Numerical Rating Scale (NRS) ranging from 0 to 10; 0=no pain to 10=pain as bad as it could be.

  T1, immediately after the procedure.

• Anxiety level

  Children's Fear Scale (CFS)(0-4)

  T0, before the procedure (baseline); T1, immediately after the procedure.

Secondary Outcomes (9)

• Presence in the game

  T1, immediately after the procedure

• Stress

  T0, before the procedure (baseline); T1, immediately after the procedure.

• Parents' and children's satisfaction levels

  T1, immediately after the procedure

• Healthcare professionals' satisfaction level

  An average of one year after the beginning of the study (mid-recruitement)

• Analgesic requirement

  T1, immediately after the procedure

Study Arms (2)

Passive Distraction

ACTIVE COMPARATOR

The child will watch a video on an iPad® during the pin removal procedure and/or removal of sutures.

Device: Passive Distraction

Virtual Reality Distraction

EXPERIMENTAL

The child will visualize and interact with the virtual environment using an Oculus Quest® head-mounted device throughout the pin removal procedure and/or removal of sutures.

Device: Virtual Reality Distraction

Interventions

Passive Distraction DEVICE

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.

Passive Distraction

Virtual Reality Distraction DEVICE

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.

Virtual Reality Distraction

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Requiring a percutaneous pins and/or sutures removal procedure,
• Accompanied by a consenting parent or legal guardian who can understand, read and write either French or English.

You may not qualify if:

• Having a diagnosed cognitive impairment preventing them from interacting with the games or answering questions related to pain, anxiety, and pain memory,
• Have a diagnosis of epilepsy or any other condition precluding them from playing a virtual reality game,
• Cannot be in a sitting or semi-upright sitting position (Fowler's position) during the procedure as the game in the virtual reality group requires an angle of at least 45 degrees for head-tracking.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Montreal Children's Hospital of the MUHC: collaborator
• Shriners Hospitals for Children: collaborator

Study Sites (3)

St. Justine's Hospital

Montreal, Quebec, H1T 3C5, Canada

Location

Shriners Hospitals for Children

Montreal, Quebec, H4A 0A9, Canada

Location

Montreal Children's Hospital of the MUHC

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (2)

• Guingo E, Debeurme MH, Dos Santos RP, Addab S, Rainville P, Bouchard S, Chougui K, Tsimicalis A, Nault ML, Ducruet T, Ledjiar O, Noel M, St-Arneault K, Cotes-Turpin C, Hung N, Ouimet P, Parent S, Gardner J, Bernstein M, Le May S. Efficacy of Virtual Reality vs. Tablet Games for Pain and Anxiety in Children Undergoing Bone Pins Removal: Randomised Clinical Trial. J Adv Nurs. 2025 Apr 29. doi: 10.1111/jan.16991. Online ahead of print.

  PMID: 40302143 DERIVED

• Le May S, Tsimicalis A, Noel M, Rainville P, Khadra C, Ballard A, Guingo E, Cotes-Turpin C, Addab S, Chougui K, Francoeur M, Hung N, Bernstein M, Bouchard S, Parent S, Hupin Debeurme M. Immersive virtual reality vs. non-immersive distraction for pain management of children during bone pins and sutures removal: A randomized clinical trial protocol. J Adv Nurs. 2021 Jan;77(1):439-447. doi: 10.1111/jan.14607. Epub 2020 Oct 24.

  PMID: 33098330 DERIVED

MeSH Terms

Conditions

Pain; Agnosia; Anxiety Disorders; Pain, Procedural; Acute Pain; Deafness, Autosomal Recessive 1A

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Mental Disorders

Study Officials

• Sylvie Le May, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel/2 groups

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: September 21, 2018
• Study Start: June 14, 2019
• Primary Completion: October 14, 2022
• Study Completion: October 25, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)