The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery

NCT06271889 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/330
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

University of Health Sciences, Istanbul Umraniye training and Research Hospital, Clinic of Obstetrics and gynecology, birth, maternity and Child Health Hospital, Aydın to the clinic, pregnant women, pregnant women in active labor act, and received acceptance to delivery to the fetal heart sound by existing tripped; fetal heart sounds of pregnant women, anxiety, pain and the birth in order to determine the effect of connecting the end of the level will be conducted. The study will guide midwives in reducing the anxiety or pain of pregnant women.

Conditions

Delivery Fear; Labor Pain; Maternal-Fetal Relations

Keywords

Fetal sound; Labor anxiety; Labor pain; Non Stress Test; Postpartum bonding

Outcome Measures

Primary Outcomes (2)

• VİSUAL ANALOG SCALE

  Visual analog scale: The scoring system is between 0 and 10. 0 is considered as no pain, while 10 is considered as unbearable pain.

  immediately Before application

• STATUS AND CONTINUOUS ANXIETY SCALE

  The state anxiety scale consists of 20 statements. The state anxiety scale requires the individual to answer the feelings or behaviors experienced in the current situation by marking one of the options such as (1) Not at all, (2) A little, (3) A lot and (4) Completely according to the degree of severity.

  immediately Before application

Other Outcomes (1)

• Postpartum Attachment Scale (PASAS):

  In the first 24 hours postpartum after delivery

Study Arms (2)

Control

NO INTERVENTION

Control group pregnant women will be selected using randomization. their babies' fetal voice will not be listened.

Intervention

ACTIVE COMPARATOR

Pregnant women in the intervention group will be selected using randomization. the fetal voice of their babies will be listened to for about 3-5 minutes with a Non-stress Tester.

Device: Non-stress test

Interventions

Non-stress test DEVICE

It will be performed with the HUNTLEIGH brand BD4000XS-2 model NST device located at the maternity clinic to listen to the fetal heart sound, approximately min 3 max 5 min will be listened to. According to the studies conducted in the literature, the half-life of adrenaline in plasma is 3 minutes when an invasive/noninvasive intervention is performed on an adult individual. Therefore, the fetal heart rate will be listened to for 3 minutes (Dalal \& Grujic; 2021; https://www.medicines.org.uk/emc/product/6284/smpc#gref https://www.ncbi.nlm.nih.gov/books/NBK482160 / )

Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Who are december the age range of 18- 35,
• The least literate,
• Which is the primiparous,
• who is at the 38-42 week of gestation
• With a single pregnancy in the vertex position,
• Who does not have a systemic disease that will interfere with normal delivery (gestational diabetes, preeclampsia, etc.),
• Who is in the active phase of labor \* Pregnant women who have agreed to participate in the study and received informed consent will be included in the study

You may not qualify if:

• \. week 42. not between the weeks dec
• It is a multipart,
• Anyone who has any problems with communication,
• Who has ceased to be involved in the study,
• An unexpected complication develops (cesarean section of the pregnant woman, development of fetal distress in the fetus, etc.).
• Oxytocin induction is applied Pregnant women who have been given pain medication (Aldolan, diazem) are

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglık Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• Lopez-Teijon M, Garcia-Faura A, Prats-Galino A. Fetal facial expression in response to intravaginal music emission. Ultrasound. 2015 Nov;23(4):216-223. doi: 10.1177/1742271X15609367.

  PMID: 26539240 RESULT

• Jelicic L, Jankovic S, Sovilj M, Adamovic T, Bogavac I, Gavrilovic A, Subotic M. Fetal Middle Cerebral Artery Pulsatility Index in No-Risk Pregnancies: Effects of Auditory Stimulation and Pregnancy Order. Int J Mol Sci. 2020 May 29;21(11):3855. doi: 10.3390/ijms21113855.

  PMID: 32485789 RESULT

• Aalbers S, Fusar-Poli L, Freeman RE, Spreen M, Ket JC, Vink AC, Maratos A, Crawford M, Chen XJ, Gold C. Music therapy for depression. Cochrane Database Syst Rev. 2017 Nov 16;11(11):CD004517. doi: 10.1002/14651858.CD004517.pub3.

  PMID: 29144545 RESULT

• Wulff V, Hepp P, Fehm T, Schaal NK. Music in Obstetrics: An Intervention Option to Reduce Tension, Pain and Stress. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):967-975. doi: 10.1055/s-0043-118414. Epub 2017 Sep 25.

  PMID: 28959060 RESULT

• Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.

  PMID: 28750631 RESULT

• Mahboubeh V, Masoumeh P, Zahra S. Comparison of vibro-acoustic stimulation and acupressure effects in nonstress test results and its parameters in pregnant women. Iran J Nurs Midwifery Res. 2013 Jul;18(4):266-71.

  PMID: 24403920 RESULT

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rojda BAYAR, PhD.Std.

  Istanbul Umraniye Training and Research Hospital

  STUDY CHAIR

• Ebru SAGIROGLU, PhD.Std.

  Uskudar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Which of the participants is the control or intervention group will be selected by randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Randomized parallel controlled experimental design

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 22, 2024
• Study Start: November 24, 2021
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)