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Music for Anxiety in Embryo Transfers (MUSIC-ET)

Primary Purpose

REPRODUCTIVE TECHNIQUES, Embryo Transfer, Music

Status
Not yet recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Music
Sponsored by
Centro de Estudios en Genetica y Reproduccion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REPRODUCTIVE TECHNIQUES focused on measuring music, embryo transfer, randomized controlled trial, anxiety, satisfaction

Eligibility Criteria

21 Years - 53 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Cegyr (Eugin group)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music

No music

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Participant satisfaction rate
It will be assessed with a visual analog scale (VAS) and an ad-hoc satisfaction rate survey.
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.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2023
Last Updated
October 23, 2023
Sponsor
Centro de Estudios en Genetica y Reproduccion
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1. Study Identification

Unique Protocol Identification Number
NCT06084793
Brief Title
Music for Anxiety in Embryo Transfers
Acronym
MUSIC-ET
Official Title
Effect of Music During an Embryo Transfer on the Anxiety and Satisfaction Levels: An Open-label Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Estudios en Genetica y Reproduccion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REPRODUCTIVE TECHNIQUES, Embryo Transfer, Music, Test Anxiety, Patient Satisfaction
Keywords
music, embryo transfer, randomized controlled trial, anxiety, satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The process of randomization and allocation concealment will be implemented through a block random computer-generated list.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
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.
Arm Title
No music
Arm Type
No Intervention
Arm Description
No music is played (usual care) in the embryo transfer room.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant satisfaction rate
Description
It will be assessed with a visual analog scale (VAS) and an ad-hoc satisfaction rate survey.
Time Frame
Immediate after the embryo transfer
Title
Participant anxiety rate
Description
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.
Time Frame
Immediate before after the embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women undergoing a fresh or frozen embryo transfer as a consequence of an ART technique Exclusion Criteria: gestational carriers deaf persons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demian Glujovsky, MD MSc
Phone
+541143728289
Email
glujovsky@cegyr.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demian Glujovsky, MD MSc
Organizational Affiliation
Cegyr (Eugin group)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cegyr (Eugin group)
City
Buenos Aires
ZIP/Postal Code
C1055ABB
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demian Glujovsky, MD MSc
Email
glujovsky@cegyr.com
First Name & Middle Initial & Last Name & Degree
Julieta Quaglia Martinez, MD
First Name & Middle Initial & Last Name & Degree
Fiamma Di Biase, MD
First Name & Middle Initial & Last Name & Degree
Julieta Glujovsky
First Name & Middle Initial & Last Name & Degree
Gabriel Federico
First Name & Middle Initial & Last Name & Degree
Agustin Ciapponi, MD MSc PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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Music for Anxiety in Embryo Transfers

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