AzTrials
AzTrials

REPRODUCTIVE TECHNIQUESMUSIC-ETNCT06084793

Music for Anxiety in Embryo Transfers

A study testing Music in people with REPRODUCTIVE TECHNIQUES and Embryo Transfer, run by Centro de Estudios en Genetica y Reproduccion at 1 site in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 21 to 53 years, women only
Conditions the study is for
REPRODUCTIVE TECHNIQUES, Embryo Transfer, Music
What is being tested?
Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteArgentina
Study dates
1 Dec 2023to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 53 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Demian Glujovsky, MD MSc contact

+541143728289

glujovsky@cegyr.com

Argentina1 site

  • Cegyr (Eugin group)

    Buenos Aires, C1055ABB

    Demian Glujovsky, MD MSc, glujovsky@cegyr.com

    Julieta Quaglia Martinez, MD

Other trials in Argentina

About this study

Official title: 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:

Read more
  • 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.

Being tested
Music
Keywords
music, embryo transfer, randomized controlled trial, anxiety, satisfaction
Medical subject headings
Patient Satisfaction, Anxiety Disorders, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT06084793
Study groupRoleWhat they receive
MusicExperimentalAll 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.
Receives: Other: Music
No musicNo interventionNo music is played (usual care) in the embryo transfer room.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant satisfaction rate

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

    Measured: Immediate after the embryo transfer

  2. 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.

    Measured: Immediate before after the embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The process of randomization and allocation concealment will be implemented through a block random computer-generated list.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06084793
Sponsor's protocol ID
MUSIC-ET-20230824
Acronym
MUSIC-ET
Status last verified
Oct 2023
First submitted
10 Oct 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Publications

  • 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.

    PubMed 31242506

  • 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.

    PubMed 23740695

  • 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.

    PubMed 10702461

  • 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.

    PubMed 33658786

  • 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.

    PubMed 34546118

  • 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.

    PubMed 7696068

  • 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.

    PubMed 24668261

  • 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.

    PubMed 21554287

  • 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.

    PubMed 24043383

  • 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.

    PubMed 11425823

  • 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.

    PubMed 35325124

  • 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.

    PubMed 20338959

Questions about this trial

What is this clinical trial studying?

A study testing Music in people with REPRODUCTIVE TECHNIQUES and Embryo Transfer, run by Centro de Estudios en Genetica y Reproduccion at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Demian Glujovsky, MD MSc (+541143728289, glujovsky@cegyr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant satisfaction rate (time frame: Immediate after the embryo transfer). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06084793, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in