NCT04539899已完成不适用
Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- NRS during IUD insertion
研究概览
简要总结
Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.
Observational, prospective, randomized, open-label, monocentric study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adult
- •Who has benefited from contraceptive counseling
- •The choice of an IUD (hormonal or copper)
- •Having signed a written informed consent.
- •Affiliation to a social security scheme.
排除标准
- •Pre-existing dizzying sensations
- •Severe facial wounds
- •History of epilepsy
- •Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
结局指标
主要结局
NRS during IUD insertion
时间窗: 20 minutes
The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful)
次要结局
- Satisfaction level difference with virtual reality(20 minutes)
- Stress level difference with virtual reality(20 minutes)
研究者
研究点 (2)
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