NCT06084793

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 10, 2023

Last Update Submit

November 15, 2023

Conditions

REPRODUCTIVE TECHNIQUESEmbryo TransferMusicTest AnxietyPatient Satisfaction

Keywords

musicembryo transferrandomized controlled trialanxietysatisfaction

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Music

EXPERIMENTAL

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

No music

NO INTERVENTION

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

Interventions

MusicOTHER

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.

Music

Eligibility Criteria

Age21 Years - 53 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • gestational carriers
  • hearing-impaired or deaf persons
  • fresh embryo transfers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cegyr (Eugin group)

Buenos Aires, C1055ABB, Argentina

Location

Related Publications (12)

  • Bai CF, Cui NX, Xu X, Mi GL, Sun JW, Shao D, Li J, Jiang YZ, Yang QQ, Zhang X, Cao FL. Effectiveness of two guided self-administered interventions for psychological distress among women with infertility: a three-armed, randomized controlled trial. Hum Reprod. 2019 Jul 8;34(7):1235-1248. doi: 10.1093/humrep/dez066.

    PMID: 31242506RESULT

  • Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.

    PMID: 23740695RESULT

  • Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.

    PMID: 10702461RESULT

  • Liu YF, Fu Z, Chen SW, He XP, Fan LY. The Analysis of Anxiety and Depression in Different Stages of in vitro Fertilization-Embryo Transfer in Couples in China. Neuropsychiatr Dis Treat. 2021 Feb 25;17:649-657. doi: 10.2147/NDT.S287198. eCollection 2021.

    PMID: 33658786RESULT

  • Mahmoud MY, Labib K, Sileem SA, Mustafa FA, Hamed WM, Abd Elhamid A, Saleh DM, Alanwar A, Riad AAM, Abdelhakim AM, Abbas AM, Mohammed HM. The impact of music therapy on anxiety and pregnancy rate among infertile women undergoing assisted reproductive technologies: a systematic review and meta-analysis. J Psychosom Obstet Gynaecol. 2022 Jun;43(2):205-213. doi: 10.1080/0167482X.2021.1977277. Epub 2021 Sep 21.

    PMID: 34546118RESULT

  • Millar K, Jelicic M, Bonke B, Asbury AJ. Assessment of preoperative anxiety: comparison of measures in patients awaiting surgery for breast cancer. Br J Anaesth. 1995 Feb;74(2):180-3. doi: 10.1093/bja/74.2.180.

    PMID: 7696068RESULT

  • Murphy EM, Nichols J, Somkuti SG, Sobel M, Braverman A, Barmat LI. Randomized trial of harp therapy during in vitro fertilization-embryo transfer. J Evid Based Complementary Altern Med. 2014 Apr;19(2):93-8. doi: 10.1177/2156587213514054. Epub 2013 Dec 18.

    PMID: 24668261RESULT

  • Pittman S, Kridli S. Music intervention and preoperative anxiety: an integrative review. Int Nurs Rev. 2011 Jun;58(2):157-63. doi: 10.1111/j.1466-7657.2011.00888.x. Epub 2011 Feb 15.

    PMID: 21554287RESULT

  • Quant HS, Zapantis A, Nihsen M, Bevilacqua K, Jindal S, Pal L. Reproductive implications of psychological distress for couples undergoing IVF. J Assist Reprod Genet. 2013 Nov;30(11):1451-8. doi: 10.1007/s10815-013-0098-7. Epub 2013 Sep 17.

    PMID: 24043383RESULT

  • Smeenk JM, Verhaak CM, Eugster A, van Minnen A, Zielhuis GA, Braat DD. The effect of anxiety and depression on the outcome of in-vitro fertilization. Hum Reprod. 2001 Jul;16(7):1420-3. doi: 10.1093/humrep/16.7.1420.

    PMID: 11425823RESULT

  • Tyler B, Walford H, Tamblyn J, Keay SD, Mavrelos D, Yasmin E, Al Wattar BH. Interventions to optimize embryo transfer in women undergoing assisted conception: a comprehensive systematic review and meta-analyses. Hum Reprod Update. 2022 Jun 30;28(4):480-500. doi: 10.1093/humupd/dmac009.

    PMID: 35325124RESULT

  • Van den Broeck U, D'Hooghe T, Enzlin P, Demyttenaere K. Predictors of psychological distress in patients starting IVF treatment: infertility-specific versus general psychological characteristics. Hum Reprod. 2010 Jun;25(6):1471-80. doi: 10.1093/humrep/deq030. Epub 2010 Mar 25.

    PMID: 20338959RESULT

MeSH Terms

Conditions

Patient SatisfactionAnxiety DisordersPersonal Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Demian Glujovsky, MD MSc

    Cegyr (Eugin group)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Demian Glujovsky, MD MSc

CONTACT

+541143728289glujovsky@cegyr.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The process of randomization and allocation concealment will be implemented through a block random computer-generated list.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

December 1, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

November 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Locations

AR(1)