Music for Anxiety in Embryo Transfers

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Music Before and During an Embryo Transfer on the Anxiety and Satisfaction Levels: An Open-label Randomized Controlled Trial

Conditions
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REPRODUCTIVE TECHNIQUES, Embryo Transfer, Music, Test Anxiety, Patient Satisfaction

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women undergoing a frozen embryo transfer as a consequence of an ART technique Exclusion Criteria: gestational carriers hearing-impaired or deaf persons fresh embryo transfers

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 53 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The process of randomization and allocation concealment will be implemented through a block random computer-generated list.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>All participants will listen to music throughout their time in the pre-transfer room and the designated embryo transfer room. The music will begin playing as soon as participants enter the room and will continue until their departure. Participants will curate a personalized playlist. | Other: Music<br>* In the pre-transfer room, the personalized playlist will be played through earphones or speakers, according to the patient´s preference. In the transfer room, the personalized playlist will be played through speakers at a volume that is loud enough for the participant to hear but soft enough to ensure clear communication between the patient and doctor, without causing any disturbance to the doctor.<br>|
| No Intervention: No music<br>No music is played (usual care) in the embryo transfer room. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction rate | It will be assessed with a visual analog scale (VAS) and an ad-hoc satisfaction rate survey. | Immediate after the embryo transfer | 
| Participant anxiety rate | 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. | Immediate before after the embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, embryo transfer, randomized controlled trial, anxiety, satisfaction