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

NCT ID: NCT06271889

Last Updated: 2026-01-12

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2024-08-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delivery Fear Labor Pain Maternal-Fetal Relations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized parallel controlled experimental design
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Which of the participants is the control or intervention group will be selected by randomization.

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Non-stress test

Intervention Type 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 / )

Interventions

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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 / )

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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YASEMİN AYDIN KARTAL

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rojda BAYAR, PhD.Std.

Role: STUDY_CHAIR

Istanbul Umraniye Training and Research Hospital

Ebru SAGIROGLU, PhD.Std.

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Locations

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Saglık Bilimleri Universitesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 26539240 (View on PubMed)

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.

Reference Type RESULT
PMID: 32485789 (View on PubMed)

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.

Reference Type RESULT
PMID: 29144545 (View on PubMed)

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.

Reference Type RESULT
PMID: 28959060 (View on PubMed)

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.

Reference Type RESULT
PMID: 28750631 (View on PubMed)

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.

Reference Type RESULT
PMID: 24403920 (View on PubMed)

Other Identifiers

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B.10.1.TKH.4.34.H.GP.0.01/330

Identifier Type: -

Identifier Source: org_study_id

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