Embryo Transfer, Music, Patient Satisfaction, REPRODUCTIVE TECHNIQUES, Test Anxiety
Conditions
Keywords
music, embryo transfer, randomized controlled trial, anxiety, satisfaction
Brief summary
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.
Interventions
OTHERMusic
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.
Sponsors
Centro de Estudios en Genetica y Reproduccion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
The process of randomization and allocation concealment will be implemented through a block random computer-generated list.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 53 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction rate | 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 | 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. |
Countries
Argentina
Contacts
Primary ContactDemian Glujovsky, MD MSc
Outcome results
None listed