Randomized Controlled Trial of Virtual Reality for Pain Management in a Specialty Rehabilitation Context
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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.
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Researcher #1 will break the blind and know which condition the participant is in. Researcher #1 will then be the one to video record the treatment session. Researcher #1 will leave the room immediately following the treatment intervention. Researcher #2 will enter the room and will support the patient, parent/caregiver, and provider in completing outcomes assessments.
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
研究组 & 干预措施
Virtual Reality for distraction
The application of VR during the putative painful treatment (botulinum toxin injections) will provide a) active and engaging distraction during the procedure, and will b) block the view and auditory noise related to the procedure.
干预措施: Virtual Reality (Device)
Standard of Care
Patients will receive the standard of care for the putative painful treatment (botulinum toxin injections).
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)
研究者
Chantel Burkitt
Clinical Scientist
Gillette Children's Specialty Healthcare