Clinical trial NCT06271889: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum Bonding at the First Phase of Delivery
Official title: The Effect of Electro-fetal monıtorısıon Sound on Anxiety, paın and Postpartum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Delivery Fear
Labor Pain
Maternal-Fetal Relations
Keywords: Fetal sound
Labor anxiety
Labor pain
Non Stress Test
Postpartum bonding
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel controlled experimental design
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: VİSUAL ANALOG SCALE
timeFrame: immediately Before application
measure: STATUS AND CONTINUOUS ANXIETY SCALE
timeFrame: immediately Before application
Secondary outcomes:
Other outcomes:
measure: Postpartum Attachment Scale (PASAS):
timeFrame: In the first 24 hours postpartum after delivery
Locations:
city: Istanbul
country: Turkey
facility: Saglık Bilimleri Universitesi
Study officials:
affiliation: Istanbul Umraniye Training and Research Hospital
name: Rojda BAYAR, Msc. Midwery
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.