Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure
详细描述
Medical interventions often cause pain, distress or anxiety for most patients.
The use of music and movies has proven effective in pediatrics.
Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.
This randomized monocentric trial compares the effect of the use of VR versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development.
The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Will benefit from in vitro Fertilization (IVF or ICSI)
- •Aged over 18 and under 43,
- •Attempt Rank 1 or 2
- •Requiring a transfer of a single fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development
- •Having received information and given their consent to participate in accordance with the regulations
- •Benefiting from a social security scheme or entitled.
排除标准
- •Use of frozen sperm
- •Use of testicular sperm
- •Fecundation technique used: IMSI
- •Early embryo transfer on D2 or D3
- •Inability to understand the information given
- •Under guardianship, under curatorship or under safeguard of justice,
- •Communication difficulties or neuropsychic disorders,
- •Current corneal or conjunctival pathologies,
- •Claustrophobia,
- •Appearance of nausea in the mountains or at sea,
- •Regular use of anxiolytics
研究组 & 干预措施
ET without RV
Patients who will be randomized to the control group will wait for transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development according to the usual service protocol.
ET with RV
The transfer and preparation in the transfer room will be done according to the usual service protocol.
Exposure to virtual reality environment exposure
干预措施: Virtual Reality during Embryo Transfer (Device)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: Assessed 12 weeks after embryo transfer
Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity
次要结局
- State and Trait Anxiety Inventory (STAI) questionnaires(Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure)
- Generalized Anxiety Disorder - 7 (GAD-7) questionnaires(Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure)