Watching Live VIA/VILI Examinations on a Digital Screen May Reduce Patients' Anxiety: a Randomized Trial of an Educational Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
The purpose of this study is to assess whether the degree of anxiety experienced by women undergoing visual inspection with acetic acid (VIA) and Lugol's iodine (VILI) can be reduced by watching the procedure in real-time on a digital screen.
详细描述
The study took place in the District of Dschang, Cameroon. Women aged between 30 and 49 years, addressed to undergo a pelvic examination with VIA and VILI, were invited to participate. Throughout the examination, one part of the women underwent the routine VIA/VILI, with no visual support (control group), whereas the other part of patients were shown the pictures of the cervix in real-time on a digital screen (study group). At the end of the procedure, all women had the possibility to see the pictures retrospectively. Randomization determined the women's distribution between the two groups. Their anxiety level was measured by asking them to complete the Spielberg's State Anxiety Inventory (STAI) both prior to and immediately after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women participating in a cervical cancer screening campaign organized by the District hospital of Dschang
- •Women understanding the study procedure and accepting voluntarily to participate by signing an informed consent form (ICF).
排除标准
- •Women not able to comply with the study protocol.
结局指标
主要结局
Anxiety level
时间窗: Within thirty minutes of the VIA/VILI examination
Anxiety level will be assessed through the STAI questionnaire
次要结局
未报告次要终点
研究者
Prof. Patrick Petignat
Professor
University Hospital, Geneva