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Decreasing REcurrent Pain and Anxiety in Medical Procedures With a Pediatric Population: Trial

NCT02947243 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-05-18

No results posted yet for this study

Summary

Children with burn injuries experience severe pain intensity during medical procedures despite the increasing doses of analgesics. Current guidelines on pediatric procedural pain management recommend the combination of non-pharmacological and pharmacological interventions to enhance pain management and decrease the numerous side effects of analgesics. Virtual reality (VR) has gained growing consideration as a non-pharmacological method as it engages multiple senses and allows interactions with a virtual world. Oculus Rift ® is a new technology in VR that provides more immersiveness, at a relatively low cost, and could probably improve the management of pain and anxiety in burn care. It also has the potential, with appropriate custom software designed for burn pediatric patients, to reduce the cybersickness symptoms (nausea, dizziness) associated with VR. To the knowledge of the investigators, none of the pediatric hospitals across Canada have tested VR as a method of pain and anxiety management in children with burn injuries. Overall hypotheses: VR distraction via Oculus Rift ® could be an effective method to relieve pain, and anxiety, as well as a less traumatizing hospital experience, while promoting a more humanistic care environment by combining new technologies (VR via Oculus Rift ®) to standard analgesic interventions administered to these children. The expected results will have a direct effect on physical (pain) and psychological (anxiety, pain memories) health of the child. In addition, clinical implications may include other indicators of quality of care and economic benefits such as a wider range of motion of burned limbs and reduction in dosage of opioids and anxiolytic drugs administered.

Conditions

Interventions

DEVICE

VR distraction via Oculus Rift

In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the burn site, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, will be adapted for children and tailored to minimize cyber sickness.

DRUG

Morphine

As per unit's protocol

Sponsors & Collaborators

  • 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
CROSSOVER

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02947243 on ClinicalTrials.gov