跳至主要内容
临床试验/NCT03521076
NCT03521076
进行中(未招募)
不适用

Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context

Gillette Children's Specialty Healthcare1 个研究点 分布在 1 个国家目标入组 49 人2018年9月21日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Muscle Spasticity
发起方
Gillette Children's Specialty Healthcare
入组人数
49
试验地点
1
主要终点
The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.
状态
进行中(未招募)
最后更新
3年前

概览

简要总结

Measure pain and anxiety during a putative painful medical procedure (i.e., botulinum toxin injections) when Virtual Reality is employed compared to standard of care only using a Randomized Controlled Trial study design.

注册库
clinicaltrials.gov
开始日期
2018年9月21日
结束日期
2024年12月
最后更新
3年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Chantel Burkitt

Clinical Scientist

Gillette Children's Specialty Healthcare

入排标准

入选标准

  • Patients receiving botulinum toxin injections at Gillette Children's Specialty Healthcare

排除标准

  • Patients who are fully anesthetized during their medical procedure
  • Non-English speaking parents/patients
  • Patients with history of motion sickness
  • Patients with epilepsy
  • Patients with a ventricular shunt
  • Patients who have surgery during the study time period

结局指标

主要结局

The Faces Pain Scale - Revised (FPS-R) to assess intensity of pain during injections.

时间窗: 2 days

The Faces Pain Scale - Revised (FPS-R) will be used to assess pain intensity before, during, and after the treatment session. The FPS-R is a self-report measure of pain intensity developed for children. This scale shows a serious of six faces depicting increasing intensity of pain expression. The FPS-R instructions orient the child to the series of faces and then ask the child to point to the face that shows how much they hurt right now. Each face corresponds to a numerical rating between 0 and 10 (0, 2, 4, 6, 8, and 10). This rating scale corresponds to the widely accepted 0-to-10 metric for pain. The "0" equals no pain and the "10" equals very much pain. The score is reported as a total score.

次要结局

  • A series of visual analogue scales (VAS) to assess pain, anxiety, satisfaction with pain management, and perceived benefits of VR.(2 days)
  • The Brief Pain Inventory (BPI)(2 days)
  • The Dalhousie Pain Interview (DPI)(2 days)
  • Information collected from the medical record (e.g., medication use during procedure).(2 days)
  • The Pain Opinion Questionnaire (POQ)(2 days)

研究点 (1)

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