MUSIC-ET: Music for Anxiety in Embryo Transfers

Sponsor

Centro de Estudios en Genetica y Reproduccion (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06084793

Collaborator

(none)

146

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to compare if playing music can make a difference for women who are going through a fresh or 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 while having the embryo transfer make patients feel more satisfied and less anxious?
Does listening to music during the embryo transfer affect how likely it is for the woman to get pregnant?

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 can help make the procedure better for women.

Condition or Disease	Intervention/Treatment	Phase
REPRODUCTIVE TECHNIQUES Embryo Transfer Music Test Anxiety Patient Satisfaction	Other: Music	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The process of randomization and allocation concealment will be implemented through a block random computer-generated list.The process of randomization and allocation concealment will be implemented through a block random computer-generated list.

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

May 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Music All participants will listen to music throughout their time in 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 be given the opportunity to curate a personalized playlist.	Other: Music 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.
No Intervention: No music No music is played (usual care) in the embryo transfer room.

Arm

Intervention/Treatment

Experimental: Music

All participants will listen to music throughout their time in 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 be given the opportunity to curate a personalized playlist.

Other: Music

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.

No Intervention: No music

No music is played (usual care) in the embryo transfer room.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 53 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

women undergoing a fresh or frozen embryo transfer as a consequence of an ART technique

Exclusion Criteria:

gestational carriers
deaf persons

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centro de Estudios en Genetica y Reproduccion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centro de Estudios en Genetica y Reproduccion

ClinicalTrials.gov Identifier:

NCT06084793

Other Study ID Numbers:

MUSIC-ET-20230824

First Posted:

Oct 16, 2023

Last Update Posted:

Oct 16, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centro de Estudios en Genetica y Reproduccion

music

embryo transfer

randomized controlled trial

anxiety

satisfaction

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 16, 2023