Music for Anxiety in Embryo Transfers (MUSIC-ET)

November 15, 2023 updated by: Centro de Estudios en Genetica y Reproduccion

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1055ABB
        • Cegyr (Eugin group)
        • Contact:
        • Sub-Investigator:
          • Julieta Quaglia Martinez, MD
        • Sub-Investigator:
          • Fiamma Di Biase, MD
        • Sub-Investigator:
          • Julieta Glujovsky
        • Sub-Investigator:
          • Gabriel Federico
        • Sub-Investigator:
          • Agustin Ciapponi, MD MSc PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No music
No music is played (usual care) in the embryo transfer room.
Experimental: Music
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant satisfaction rate
Time Frame: Immediate after the embryo transfer
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
Time Frame: 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.
Immediate before after the embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Estudios en Genetica y Reproduccion

Investigators

  • Principal Investigator: Demian Glujovsky, MD MSc, Cegyr (Eugin group)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

October 10, 2023

First Submitted That Met QC Criteria

October 10, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUSIC-ET-20230824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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