Effect of Music Before and During an Embryo Transfer on the Anxiety and Satisfaction Levels: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Participant satisfaction rate
研究概览
简要总结
The goal of this clinical trial is to compare if playing music before and during an embryo transfer can make a difference for women who are going through a frozen embryo transfer as part of a medical procedure called assisted reproduction technology (ART).
The main questions it aims to answer are:
- Does listening to music before and while having the embryo transfer make patients feel more satisfied and less anxious?
- Does listening to music before and during the embryo transfer affect how likely it is for the woman to get pregnant?
Before the embryo transfer, the participants will listen to music through earphones or speakers. During the embryo transfer, the participants will listen to music through speakers.
During the embryo transfer, the comparison group will not listen to music and will receive the usual care.
The aim is to see if listening to music before and during the embryo transfer can help make the procedure better for women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Sealed opaque envelopes will be employed within the 7 days preceding the embryo transfer (for fresh transfers, it will be done on the day of fertilization, and, for frozen transfers, it will be done once the endometrium is prepared and it is ready to start the progesterone supplementation). Both the participants and the attending physician will be aware of the assigned allocation group. The researcher responsible for outcome assessment will remain blinded to the allocation.
入排标准
- 年龄范围
- 21 Years 至 53 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women undergoing a frozen embryo transfer as a consequence of an ART technique
排除标准
- •gestational carriers
- •hearing-impaired or deaf persons
- •fresh embryo transfers
结局指标
主要结局
Participant satisfaction rate
时间窗: Immediate after the embryo transfer
It will be assessed with a visual analog scale (VAS) and an ad-hoc satisfaction rate survey.
Participant anxiety rate
时间窗: Immediate before after the embryo transfer
It will be assessed with State-Trait Anxiety Inventory (STAI-S), a validated tool. It will be evaluated before and after the embryo transfer (we will compare the absolute difference in the evaluation post-transfer, and also the difference between the pre and post-embryo transfer.
次要结局
未报告次要终点