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临床试验/NCT04538573
NCT04538573招募中不适用

Virtual Reality MObility for Burn Patients (VR-MOBILE): A Pilot Randomized Clinical Trial

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Pain intensity: Verbal Numerical Rating Scale (VNRS)

研究概览

简要总结

Background

In the acute phase, burn patients undergo several painful procedures. Pediatric burn care procedures conducted in hydrotherapy have been known to generate severe pain intensity and moderate to high levels of anxiety. Hydrotherapy treatments are done with the use of opioids and benzodiazepines for pain and anxiety. Unfortunately, non-pharmacological methods are rarely combined with pharmacological treatments despite evidence showing that distraction can serve as an effective method for pain management and can potentially decrease analgesic requirements in other painful medical procedures. Virtual Reality (VR) is a method that uses distraction to interact within a virtual environment. The use of VR is promising for pain reduction in varying settings. Considering the lack of optimal pain and anxiety management during burn wound care and the positive effect of an immersive distraction for painful procedures, using VR for burn wound care procedures may show promising results.

Methods

This is a within-subject randomized controlled trial design in which each participant will serve as his/her own control. A minimum of 20 participants, aged 7 to 17 years old undergoing a burn care session, will receive both standard and experimental treatments during the same session in a randomized order. The experimental treatment will consist of combining VR distraction using the video game Dreamland® to the current standard pharmacological care as per unit protocol. The control group will only receive the unit's standard pharmacological care. The mean difference in both pain intensity scores and in anxiety between the two different sequences will be the primary outcomes of this study.

Conclusion

This study evaluates the effect of VR on burn wound care. If results from this study show a positive effect of VR compared to standard care, this protocol may provide guidance on how to implement this type of immersive care as part of the tools available for distraction of painful procedures for acute burn victims.

详细描述

BACKGROUND

Pediatric burn care procedures in hydrotherapy have been known to generate severe pain intensity as well as moderate to high levels of anxiety. In the acute phase, burn patients undergo several painful procedures including wound debridement, passive range-of-motion (ROM) exercises and dressing change treatments. These procedures are important for proper rehabilitation as they prevent contractures, muscle spasms and limited joint mobility. These possible complications result from the normal healing process following a burn injury and are mainly due to scarring and loss of skin elasticity .1,2

Hydrotherapy in burn care is done with the use of opioids and benzodiazepines, since regular analgesics, such as acetaminophen alone, are often inadequate for pain and anxiety management.3,4 As hydrotherapy treatments cause a great deal of pain compared to standard burn care, high dose of narcotics is required to reach an acceptable level of pain relief. The delicate balance between pain relief and opioid requirements is often at the limit of respiratory depression and the occurrence of side effects such as nausea and vomiting. Unfortunately, non-pharmacological methods are rarely combined with the pharmacological treatments used to relieve pain during hydrotherapy even if they could decrease the necessary dose of analgesics and benzodiazepines.

Virtual Reality (VR) is a method that uses distraction to interact within a virtual environnement.3 Flexibility and variety of content make of VR a promising tool for pain reduction, able to be adapted to procedures and to different patient.5-8 Other positive effects including reduction of anxiety for painful procedures have been reported by children and adults. 9-12 Furthermore, recent randomized-controlled trials 9,10 comparing VR and standard distraction in children during painful procedures demonstrated a significant effect on pain and anxiety which enhanced patients', caregivers' and phlebotomist's satisfaction. Also, Gold and Maher 10 concluded that children with higher anxiety sensitivity had better results, adding support for the adoption of this new technology in children's health care. However, VR is also associated with certain side effects such as an increased nausea and the feeling of cybersickness. 13,14

Only a few authors have studied the effect of VR on procedural pain and anxiety management in burn children older than 6 years old. Indeed, a review of the literature has yielded only three studies who used VR with burn children.1,3,15 A study compared the efficacy of VR with standard pharmacological care in an RCT on 54 children (6 to 19 years) suffering from burn-related injuries with TBSA (Total Body Surface Area) varying from 1% to >50%.1 Results showed better pain control and maximum ROM in children in the VR group.1 Another study combined participants from three studies (to increase power) to compare the use of VR with standard pharmacological care with children undergoing physical therapy following a major burn.15 Results on 110 children also showed that VR significantly decreased pain and unpleasantness related to pain in children with burns.15

研究设计

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

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 6 to 17 years and suffering from a burn injury requiring hydrotherapy, physiotherapy or occupational therapy care
  • Presence of a consenting parent who can understand, read and write either French or English.

排除标准

  • Have a diagnosed cognitive impairment precluding them from playing a virtual reality game
  • Suffer from epilepsy considering the nature of the intervention
  • Have burn injuries on the face preventing the use of the Oculus Quest Helmet
  • Cannot be in a sitting or semi-upright sitting position (semi-Fowler's position) during the procedure as the virtual reality game requires an angle of at least 30 degrees for head-tracking. Participants who received analgesics (e.g. acetaminophen, ibuprofen) or anxiolytics (e.g. benzodiazepines) during the last 4 hours prior to the procedure will not be excluded but the name of medication, dosage and time of administration will be documented in the data collection form.

研究组 & 干预措施

Virtual Reality Distraction

Experimental

Use of virtual reality (VR) during during burn treatment, dressing changes and hydrotherapy.

干预措施: Virtual Reality Distraction (Device)

Standard Treatment

Active Comparator

Standard treatment during burn treatment, dressing changes and hydrotherapy.

干预措施: Standard Treatment (Drug)

结局指标

主要结局

Pain intensity: Verbal Numerical Rating Scale (VNRS)

时间窗: Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2)

Assessed using the Verbal Numerical Rating Scale (VNRS). The NRS is an 11-item scale for pain intensity ranging from 0 to 10; 0=no pain to 10= worst pain ever felt.

Levels of anxiety

时间窗: Before the procedure to establish baseline (T0); immediately after the first sequence (T1); immediately after the second sequence (T2)

Assessed using the Child Fear Scale (CFS). The CFS is a self-reported measure of anxiety adapted from the Faces Anxiety Scale for specific use in children undergoing painful experiences. It consists of five faces ranging from 0 (no fear/anxiety) through 4 (extremely fearful/anxious). The child is asked to indicate which face shows best how he/she felt during the procedure.

次要结局

  • Mean difference in cognitive, affective and sensory components of pain between groups(Immediately after the first sequence (T1); immediately after the second sequence (T2))
  • Need for rescue medication(Immediately after the first sequence (T1); immediately after the second sequence (T2))
  • Children's satisfaction levels(Immediately after the second sequence (T2))
  • Mean differences in children's memory of pain(One week after the procedure (T3))
  • Mean differences in children's memory of anxiety(One week after the procedure (T3))
  • Healthcare professional's satisfaction level(Immediately after the second sequence (T2))
  • Occurrence of adverse events(Immediately after the first sequence (T1); immediately after the second sequence (T2))

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 (1)

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