Music for Anxiety in Embryo Transfers

NCT ID: NCT06084793

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

REPRODUCTIVE TECHNIQUES Embryo Transfer Music Test Anxiety Patient Satisfaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

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.

No music

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

53 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centro de Estudios en Genetica y Reproduccion

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Demian Glujovsky, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Cegyr (Eugin group)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cegyr (Eugin group)

Buenos Aires, , Argentina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Demian Glujovsky, MD MSc

Role: CONTACT

+541143728289

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Demian Glujovsky, MD MSc

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 31242506 (View on PubMed)

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.

Reference Type RESULT
PMID: 23740695 (View on PubMed)

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.

Reference Type RESULT
PMID: 10702461 (View on PubMed)

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.

Reference Type RESULT
PMID: 33658786 (View on PubMed)

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.

Reference Type RESULT
PMID: 34546118 (View on PubMed)

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.

Reference Type RESULT
PMID: 7696068 (View on PubMed)

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.

Reference Type RESULT
PMID: 24668261 (View on PubMed)

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.

Reference Type RESULT
PMID: 21554287 (View on PubMed)

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.

Reference Type RESULT
PMID: 24043383 (View on PubMed)

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.

Reference Type RESULT
PMID: 11425823 (View on PubMed)

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.

Reference Type RESULT
PMID: 35325124 (View on PubMed)

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.

Reference Type RESULT
PMID: 20338959 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MUSIC-ET-20230824

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sound Origins Acceptability Study
NCT07021469 NOT_YET_RECRUITING NA