Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Peak pain
研究概览
简要总结
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
The intervention in the study group was to use a virtual reality (VR) device (Meta Quest2) as a distraction technique during the OH.
The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH
详细描述
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy (OH).
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group.
In the standard hysteroscopy protocol, all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure. They are also suggested to take Bromazepam 1.5 mg two hours before the procedure if they feel anxious.
The standard care group had a trained nurse providing distraction and emotional support.
The study group had a VR device (Meta Quest 2) with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients' perceived pain or satisfaction with the OH, comparing it with the standard care group.
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
盲法说明
Blinding of participants or care providers was not feasible to implement due to the nature of the intervention
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Consecutive women candidates to undergo an OH
- •Women aged 18 to 70 years old
排除标准
- •Visual impairment
- •Hearing impairment
- •Language barrier impeding the correct explanation of the study
- •Contraindication for using the VR device
- •Confirmed malignant endometrial disease
- •Anatomical characteristics impeding the office hysteroscopy
结局指标
主要结局
Peak pain
时间窗: 5-10 minutes after the procedure
a Visual analogue score (VAS score) between 0 and 10, patients reported their peak perceived pain during the procedure, being 0 no pain and 10 worst pain imaginable
Mean pain
时间窗: 5-10 minutes after the procedure
a VAS score between 0 and 10, patients reported their mean perceived pain during the procedure worst pain imaginable
次要结局
- Patient satisfaction with the information received(5-10 min before the procedure)
- Patient overall satisfaction with the procedure (OH)(5-10 min after the procedure)
- Patient satisfaction with the VR intervention(5-10 min after the procedure)