Clinical Effectiveness of Virtual Reality Simulation in Reducing Discomfort, Anxiety and Pain During Intrauterine Device Insertion: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Patients overall experience of IUD insertion
研究概览
简要总结
Aim of this study is to evaluate the effect of VR on the patients overall experience during the IUD insertion procedure.
详细描述
A single center, investigator initiated randomized controlled clinical trial. 200 women to be recruited, 100 in the intervention group and 100 in the control group.
The control group will receive the usual treatment (without specific pain management) and the intervention group will receive the usual treatment with VR support.
Endpoints are:
- Objective: successful procedure, need for general anesthesia, presence of syncope and/or vomitus
- Subjective: Pain, procedural cooperation, the degree of difficulty encountered by the physician in performing the treatment, ability to complete VR procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women who are seeking hormonal intrauterine contraception will be offered participation in the trial if they are 18 years of age or older (minors can be included if a guardians permission has been obtained), are not pregnant, and are willing to follow-up after 6 weeks for a sonographic IUD check.
排除标准
- •Auditive or visual disabilities
- •Invalidating claustrophobia
结局指标
主要结局
Patients overall experience of IUD insertion
时间窗: At insertion
Primary outcome of this study is the patients overall experience of the insertion / replacement of a hormonal IUD. This will be measured by using a Visual Analog Scale (0-100mm, continuous scale). The left extreme of this scale represents no distress, and the right extreme represents unbearable distress.
次要结局
- Discomfort(At insertion and 6 weeks later)
- Pain during insertion(At insertion and 6 weeks later)
- Degree of difficulty encountered by the physician(At insertion)
- Success rate of the procedure(At insertion and 6 weeks later)
- Patient satisfaction on the longer term(6 weeks after insertion)
- Side events(At insertion)
研究者
Prof Dr Dirk Timmerman
Clinical Head Gynecology
Universitaire Ziekenhuizen KU Leuven