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临床试验/NCT03064061
NCT03064061Unknown不适用

Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
impact of the virtual reality on the pregnancy rate (Ultrasound)

研究概览

简要总结

The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
  • Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)

排除标准

  • Patients with long-term psychotherapeutic treatment
  • Patients taking psychotropic drugs
  • patient blind and deaf

研究组 & 干预措施

Virtual Reality Neutral

Sham Comparator

neutral VR session before oocytes retrieval

干预措施: Virtual reality (Device)

Virtual reality Anxiety

Active Comparator

VR session with the goal of reducing anxiety before oocytes retrieval

干预措施: Virtual reality (Device)

结局指标

主要结局

impact of the virtual reality on the pregnancy rate (Ultrasound)

时间窗: 12 weeks

measured by ultrasound

次要结局

  • state-trait Anxiety Inventory(immediate)
  • impact of the virtual reality on satisfaction(immediate)
  • impact of the virtual reality on pregnancy test(6 weeks)
  • impact of the virtual reality on anxiety (numeric scale)(immediate)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roelants

MD

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

研究点 (2)

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