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Virtual Reality Compared to Passive Distraction for Pain Management During Orthopedic Procedures in Children: A Randomized Controlled Trial

ClinicalTrials.gov · COMPLETED, 2022

188 participants

Abstract

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,…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 188 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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