Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Outpatient Hysteroscopy and Endometrial Biopsy in Subfertility Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Change in pain experience as assessed using visual analog scale
研究概览
简要总结
This study is a comparison between the current standard practice of performing a diagnostic hysteroscopy and a relatively recently developed technology that is added to the standard diagnostic hysteroscopy. The aim of the study is to find out whether this newer technology has an advantage for the patient, in the form of anxiety and pain reduction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •undergoing fertility treatments
- •for which outpatient hysteroscopy has been prescribed
- •for different possible indications: suspicion of intracavitary pathology, recurrent implantation failure, recurrent early pregnancy loss, ...
排除标准
- •Hearing impairments and blindness
- •Motion sickness
- •Any known anatomical characteristics that may make performing the office procedure impossible.
- •The unwillingness of the patient to undergo an office hysteroscopy
- •Denial or withdrawal of informed consent
研究组 & 干预措施
investigational group
Virtual Reality
干预措施: Oncomfort, commercially available Virtual Reality headset (Device)
reference group
standard of care
结局指标
主要结局
Change in pain experience as assessed using visual analog scale
时间窗: 1/ baseline pre-procedure 2/ immediately after the procedure (1+2= day of office hysteroscopy) and 3/ 1 week after the procedure
quantified through visual analog scale: from 0.0 to 10.0cm, ranging from 0.0 meaning 'No pain' and 10.0 representing 'worst imaginable pain'.
次要结局
未报告次要终点