Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Comparison of Visual Analogue Scale Mean Scores by Groups
研究概览
简要总结
Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.
Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group.
详细描述
Patient allocation to either the VR group or the control group will be determined through a randomization process employing sealed opaque envelopes. Patients in the VR group will engage in interactive gaming experiences facilitated by VR devices. The primary outcome measure will be the assessment of pain levels during colonoscopy, which will be quantified using the "Visual Analogue Scale." Additionally, researchers will assess anxiety levels using the "State-Trait Anxiety Inventory" both before and after the colonoscopy procedure. Vital signs during colonoscopy, procedural effects, and adverse effects would also be analyzed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 50 years of age
- •Able to cooperate and complete the questionnaires independently
- •Stable vital signs with no serious cardiovascular or cerebrovascular diseases
- •Voluntary participation
排除标准
- •Severely impaired in vision or hearing to accommodate VR devices
- •Previous history of anxiety, depression, cognitive impairment, balance disorder, mental illness, or epilepsy
研究组 & 干预措施
Virtual Reality
The virtual reality hardware includes a headset (OLED display mode), a headset cable, a High-Definition Multimedia (HDM) cable, a processor unit, an Alternating Current (AC) power converter, a six-axis dynamic sensing system (three-axis gyroscope, three-axis accelerator sensor), a cinema AC screen, and a camera. The software that patients would be engaged in is highly interactive and requires total attention for about 15 minutes. The device would be tried out by the patients prior to the operation.
干预措施: Nonpharmacological method (Other)
Control
Patients undergo traditional colonoscopy procedures.
结局指标
主要结局
Comparison of Visual Analogue Scale Mean Scores by Groups
时间窗: Evaluated immediately after colonoscopy.
Pain scoring will apply the Visual Analogue Scale (VAS), which is a visual measurement using an axis rated by 0-10, with 0 for painless and 10 for the severest pain. Subjects will report the lightest score, average score, and highest score regarding pain during colonoscopy, and the mean score will be calculated. The emotional change caused by pain and attention given to the presence of pain will also be reported to adjust the main outcome.
次要结局
- Comparison of Vital Signs between Groups: Respiration Rate(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Vital Signs between Groups: Oxygen Saturation(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Vital Signs between Groups: Blood Pressure(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Adverse Effects in both groups(During and immediately after colonoscopy.)
- Comparison of State Trait Anxiety Inventory Mean Scores by Groups(Evaluated immediately both prior and after colonoscopy.)
- Comparison of Vital Signs between Groups: Pulse Rate(Evaluated both before and every 3 minutes during colonoscopy.)
- Comparison of Patient Satisfaction of Colonoscopy between Groups(Evaluated immediately after colonoscopy.)
- Comparison of Patient Willingness of Future Colonoscopy between Groups(Evaluated immediately after colonoscopy.)