Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Discomfort associated with peripheral IV placement
研究概览
简要总结
Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.
详细描述
This is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral IV (PIV) placement. Adult patients who require PIV placement for elective surgery will be consented for intervention while in the peri-operative suites (PS). The VR intervention will consist of a headset and immersive VR software that allows the patient to engage in a virtual world during PIV placement. Subjects will be queried immediately after PIV placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with PIV placement (Appendix A). They will also be asked two validated questions concerning patient satisfaction (Dexter et al 1997). A control group of patients will undergo a similar assessment with slightly different wording after receiving PIV placement without iVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.
排除标准
- •Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.
结局指标
主要结局
Discomfort associated with peripheral IV placement
时间窗: This outcome will be measured immediately after peripheral IV placement
Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.
次要结局
- Claustrophobia(This outcome will be measured immediately after peripheral IV placement)
- Clinical significance(This outcome will be measured immediately after peripheral IV placement)
- Degree to which subject felt immersed in virtual reality(This outcome will be measured immediately after peripheral IV placement)
- Nausea(This outcome will be measured immediately after peripheral IV placement)
- Satisfaction score(This outcome will be measured immediately after peripheral IV placement)
- Physiological parameters(Initial vital signs at start of anesthesia care will be abstracted retrospectively. This reading will likely occur within an hour of the initial intervention, as start times for anesthesia cases are within an hour of initiation of peri-operative care)
- Fun factor(This outcome will be measured immediately after peripheral IV placement)
- Magnitude of pain severity(This outcome will be measured immediately after peripheral IV placement)
- Time spent thinking about pain(This outcome will be measured immediately after peripheral IV placement)
研究者
Annie Chow
Principal Investigator
Brooke Army Medical Center