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临床试验/NCT03680625
NCT03680625已完成不适用

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

St. Justine's Hospital6 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2019年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
188
试验地点
6
主要终点
Anxiety level

研究概览

简要总结

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.

详细描述

BACKGROUND

In children, many fractures treated surgically will be stabilized percutaneously with Kirschner wires and some will require sutures to help the surgical wound to heal. When the fracture is adequately healed, the percutaneous wires and/or the sutures are generally removed in the outpatient clinic. These procedures represent a potential source of pain, stress and anxiety for the patient, as well as for the parents and the caregivers.

A study looked at different types of analgesia during percutaneous pin removal comparing Acetaminophen, Ibuprofen and placebo but no clinically nor statistically significant difference was found among the three groups. Another study compared topical liposomal lidocaine to a placebo but found no statistically significant difference in postprocedure pain scores between groups. On the other hand, administration of narcotics or procedural sedation for pin removal procedure probably exceeds the real needs for the majority of patients. Adding the fact that the administration of narcotics or procedural sedation requires monitoring post administration, those options lengthen visit time, reduce significantly the efficiency in an outpatient clinic setting and are not recommended for routine administration.

In contrast, there seems to be some emerging evidence about distraction methods such as distraction techniques facilitated by a hospital play specialist for pin removal procedures. Distraction use for children in orthopedic outpatient clinics has been reported anecdotally in some literature but, to our knowledge, has never been formally assessed in a randomised controlled trial. Exploring non-pharmacological interventions, including distraction, could be a promising venue for pain management in this population as they are simple, practical, easily implementable and usually without side effects.

Virtual Reality (VR) is a distraction method that allows the user to interact with an immersive environment generated by a computer stimulating different senses. A review of studies on VR, mostly conducted with adult burn patients, showed a 35 to 50% reduction in procedural pain while using VR. Its positive effect has also been reported on anxiety and general distress during painful medical procedures in children and in adults such as venipuncture, wound care, chemotherapy, dental procedures, etc. A recent randomized-controlled trial comparing VR and standard distraction in children undergoing blood drawn procedures, demonstrated a significant positive effect of VR on pain and anxiety reduction as well as patients', caregivers' and phlebotomist's satisfaction. The authors also concluded that VR was more effective for children with higher anxiety sensitivity, adding another plus value to this new technology in children's care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Anxiety level

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

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

Pain intensity

时间窗: T1, immediately after the procedure.

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.

次要结局

  • Children's memory of pain(T2, one week after the procedure)
  • Stress(T0, before the procedure (baseline); T1, immediately after the procedure.)
  • Analgesic requirement(T1, immediately after the procedure)
  • Side effects(T1, immediately after the procedure.)
  • Children's memory of anxiety(T2, one week after the procedure)
  • Presence in the game(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))
  • Co-interventions(T1, immediately after the procedure)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Le May

Principal Investigator

St. Justine's Hospital

研究点 (6)

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