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

The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum

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.

Study Overview

• Status: Recruiting
• Conditions: Labor Pain; Maternal-Fetal Relations; Delivery Fear
• Intervention / Treatment: Device: Non-stress test

Detailed Description

Application of the Research: Informed voluntary consents will be obtained in written and oral form by giving the necessary information about the study to pregnant women before the application. The form will be signed ". Environmental stimuli before the procedure (noise, heat, light, touch, etc.) will be brought under control. Pregnant women admitted to the maternity hospital will be assigned to the intervention and control group using computer-aided randomization. Routine maintenance will be applied to both groups in the study. Anamnesis and blood are routinely taken from pregnant women admitted to the maternity unit within the scope of routine care in the institution where the research was conducted, and NST is connected by inserting an intravenous catheter. STAI and VAS will be filled in before the application to both groups of pregnant women. after application, the forms will be applied again at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm). In both groups; pulse, respiration and oxygen saturation will be evaluated with body temperature at the beginning of the active phase (cervical opening 4-5 cm) and at the end (cervical opening 6-7 cm) before and after the application. With decemberibel meter, the frequency range will be kept within the range of 30 dB-90 dB. Participants will be able to adjust the volume of their baby's voice at their own level. No noninvasive and invasive interventions will be applied to pregnant women in the intervention group during the application. If the control group is pregnant, only routine care will be performed. Both groups of pregnant women will be completed with STAI, VAS and the Postpartum Attachment scale before and after the application. The researcher should constantly monitor and evaluate the mother and fetus during the application process, and when discomfort develops, the procedure will be terminated and the clinical specialist physician will be informed.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rojda BAYAR, Msc. Midwery; Phone Number: +905393956925; Email: rojdabayar95@outlook.com
• Study Contact Backup: Name: YASEMİN AYDIN KARTAL, associate professor; Phone Number: 1164 +90 5432870029; Email: yasemin.aydin@sbu.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Sağlık Bilimleri Üniversitesi
    • Contact: YASEMİN AYDIN KARTAL; Phone Number: +90 5432870029; Email: yasemin.aydin@sbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 37. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group pregnant women will be selected using randomization. their babies' fetal voice will not be listened.
Active Comparator: Intervention; 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; 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 / )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Attachment Scale (PASAS):	Postpartum Attachment Scale (PASAS): It was developed by Brockington et al. (2001) to evaluate the mother's attachment to her baby in the postpartum period and to identify problems in the relationship between mother and baby. Turkish validity and reliability study was conducted (Yalçın et al, 2014). The scale, which was answered by mothers, consists of 25 questions and is a 6-point Likert-type scale defined as "always", "very often", "quite often", "sometimes", "rarely" and "never". 17 of the questions are calculated in reverse order. These questions are questions 2, 3, 5, 6, 7, 10, 12, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24. High scores obtained from the scale indicate an increase in attachment problems.	In the first 24 hours postpartum after delivery

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Study Chair: Rojda BAYAR, Msc. Midwery, Istanbul Umraniye Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Estimated): February 24, 2024
• Study Completion (Estimated): November 20, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Labor pain; Non Stress Test; Fetal sound; Labor anxiety; Postpartum bonding
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01/330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No