Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
Randomized controlled trial to measure pain experience, side effects and satisfaction of VR following varicose vein, hernia repair and gallbladder surgeries.
详细描述
While there is substantial evidence supporting the use of Virtual Reality (VR) during dressing changes for burn victims, there are little information of the effect of VR to decrease pain after surgery. Although pharmacological analgesics are popular in clinical practice, this approach usually is associated with side effects, most commonly nausea, cognitive dysfunction, and constipation. Generally, VR effects are based on gate theory of cognitive load, due to the fact that conscious attention is needed to perceive pain and we can process a finite amount of information.High-Tech-VR devices shown to be more effective in reducing pain than are Low-Tech-VR systems (Prothero, J. D., & Hoffman, H. D, 1995). In addition, studies have shown that interactivity play an important role to decrease both, pain unpleasantness and time spent thinking about pain, while increasing fun (Wender, R., et al., 2010, Gromala, D., et al 2011). Thus, interactivity helps patients to have a better immersion into VR world. Considering this, in the proposed study, patients will be randomized to either receive a high immersive and interactive VR environment using Oculus Rift Headset in addition to standard care or to receive only standard care during their post-operative care following surgery to prospectively assess the utility of virtual reality (VR) for pain management following varicose vein, hernia repair and gallbladder surgeries.
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
- Double (Participant, Care Provider)
盲法说明
As we had two groups in which one used a device for ensuring the masking the entire procedure was conducted in a separate room.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with varicose vein, hernia repair or gallbladder surgery
- •Patient in the acute care units, 1-3 days following surgery.
- •Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
排除标准
- •Non-Romanian speaking patients.
- •Age > 18 years and < 65 years.
- •Patients with neoplastic pathologies.
- •Patients with history of motion sickness.
- •Patients with visual impairment.
- •Patients with severe/profound cognitive impairments measured with Six-item Cognitive Impairment Test (6CIT).
研究组 & 干预措施
Virtual Reality
Patients randomized to the experimental group will benefit from the usual standard care following surgery and during the second day the opportunity to use virtual reality for 15 minute. Along VR, they will complete the psychological and physiological measures.
干预措施: Virtual Reality intervention - Oculus Rift HD (Device)
Non-VR condition (Standard of Care)
Patients randomized to the control group will benefit from the usual standard care following surgery and during the second day will complete the psychological and physiological measures.
结局指标
主要结局
Pain intensity
时间窗: 15 minutes - During the intervention
Skin conductance response
Pain intensity
时间窗: Pain intensity before intervention; Change from Baseline pain intensity (immediately following intervention)
Graphic Rating Scale measure pain intensity from 1 to 10, 1 - no pain; 10 - worst pain.
Pain intensity
时间窗: 5 minutes before intervention (baseline)
Skin conductance response
次要结局
- Relaxation(Relaxation level before intervention; Change from Baseline relaxation level (immediately following intervention))
- Satisfaction with the intervention(Immediately following intervention)
- Presence in the VR environment(Immediately following intervention)
- Simulator Sickness(Immediately following intervention)
- Time thinking about pain(immediately following intervention)
研究者
Raluca Georgescu
Phd student
Babes-Bolyai University
