跳至主要内容
临床试验/NCT03776344
NCT03776344已完成2 期

Efficacy of Virtual Reality for Post Operative Pain: A Randomized Controlled Trial

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年10月10日最近更新:
适应症
干预措施

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

Experimental

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)

No Intervention

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

发起方
Babes-Bolyai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raluca Georgescu

Phd student

Babes-Bolyai University

研究点 (1)

Loading locations...

相似试验