NCT06331949

Brief Summary

Women go through many practices during their pregnancy. These practices, along with ignorance, create stress in the mother. However, performing the procedures for the first time may increase the mother's stress level. Stress during pregnancy also affects prenatal attachment. Non-Stress Test (NST) Application is a test applied to pregnant women starting from the 28th week of pregnancy and provides information about the baby's well-being and uterine contractions. There is a gap in the literature regarding education for pregnant women undergoing NST regarding stress levels and prenatal attachment. With this study, stress levels and prenatal attachment levels in pregnant women will be determined during NST, which is frequently applied during pregnancy. Additionally, the effects of midwifery care in this process will be realized. In this way, solutions will be produced for problems that may arise. A better quality of midwifery care will be provided

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

March 16, 2024

Last Update Submit

May 10, 2025

Conditions

Keywords

NSTprenatal attachmentvideoeducationState-Trait Anxiety

Outcome Measures

Primary Outcomes (2)

  • State-Trait Anxiety Scale

    It requires the person to mark one of four options, such as 1 (Not at all), 2 (Somewhat), 3 (A lot), 4 (Completely), depending on the intensity of his/her feelings about himself/herself at a certain time and under certain conditions.

    Baseline]

  • Prenatal Attachment Inventory (PAI)

    PAI is used to explain the thoughts, feelings, and situations experienced by the woman during pregnancy and to determine the level of attachment to the baby in the prenatal period. The increase in the score received by the pregnant woman indicates that her attachment level also increases.

    Baseline]

Secondary Outcomes (2)

  • State-Trait Anxiety Scale

    after training is completed

  • Prenatal Attachment Inventory (PAI)

    after training is completed

Other Outcomes (2)

  • State-Trait Anxiety Scale

    two weeks after training is completed

  • Prenatal Attachment Inventory (PAI)

    two weeks after training is completed

Study Arms (2)

Experimental Group

EXPERIMENTAL

In addition to midwifery care, training content, training videos and brochure-supported training on NST will be provided. The NST device will be inserted and, to be standard, 5 minutes after the procedure begins, the volume of the fetal heart sound coming from the device will be increased during the NST recording and the fetal heart sound will be ensured to continue. The pregnant woman who will be transferred will rest for about 2 minutes.

Other: video assisted training

Control Group

NO INTERVENTION

No additional applications will be made

Interventions

Ebelik bakımının yanı sıra NST konusunda eğitim içerikleri, eğitim videoları ve broşür destekli eğitimler verilecek. NST cihazı takılacak ve standart olarak işlem başladıktan 5 dakika sonra NST kaydı sırasında cihazdan gelen fetal kalp sesinin şiddeti artırılarak fetal kalp sesinin devam etmesi sağlanacaktır. Transfer edilecek hamile kadın yaklaşık 2 dakika kadar dinlenecektir.

Experimental Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primiparous pregnant woman
  • Able to read and write
  • Pregnant women who are 32 weeks or more pregnant
  • No detection problems
  • The baby has no health problems
  • Having no psychological or physiological health problems
  • Pregnant women who accept the research

You may not qualify if:

  • Under 32 weeks
  • Those who did not accept the research
  • If the pregnant woman feels uncomfortable during the research,
  • Pregnant women who want to leave any part of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (22)

  • Kaya, D. (2021). Gebeliğin Oluşumu ve Fizyolojisi. Içinde Ö. Doğan Yüksekol, F. Evcili, & G. Doğaner (Ed.), Normal gebelik ve bakım (1. bs, ss. 64-86). Ankara Nobel Tıp Kitapevleri.

    BACKGROUND
  • Aksay, Y., Gülhan, Y. B., Saygın, N., & Körükçü, Ö. (2017). Gebelerin Psikososyal Sağlıkları Doğum Tercihini Etkiler Mi? Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi, 6(4), 138-145

    BACKGROUND
  • Kaloğlu Bi̇ni̇ci̇, D., & Köse Tuncer, S. (2020). Primipar ve Multipar Gebelerde Algılanan Stres ve Etkileyen Faktörlerin İncelenmesi. Ebelik ve Sağlık Bilimleri Dergisi, 3(3), 189-202.

    BACKGROUND
  • Özkan, H., & Mucuk, Ö. (2021). Gebelikte Ruh Sağlığında Meydana Gelen Değişimler ve Bakım. Içinde Ö. Doğan Yüksekol, F. Evcili, & G. Doğaner (Ed.), Normal gebelik ve bakım (1. bs, ss. 175-184). Ankara Nobel Tıp Kitapevleri.

    BACKGROUND
  • Genç Koyucu, R., Ülkar, D., & Erdem, B. (2020). Primipar ve Multipar Gebelerin Gebelik Streslerinin Karşılaştırılması. İnönü Üniversitesi Sağlık Hizmetleri Meslek Yüksekokulu Dergisi, 8(3), 652-663. https://doi.org/10.33715/inonusaglik.745511

    BACKGROUND
  • Nakamura Y, Okada T, Morikawa M, Yamauchi A, Sato M, Ando M, Ozaki N. Perinatal depression and anxiety of primipara is higher than that of multipara in Japanese women. Sci Rep. 2020 Oct 13;10(1):17060. doi: 10.1038/s41598-020-74088-8.

    PMID: 33051530BACKGROUND
  • Üst, Z. D., & Pasinlioğlu, T. (2015). Primipar ve Multipar Gebelerde Doğum ve Postpartum Döneme İlişkin Endişelerin Belirlenmesi. Journal of Health Science and Profession, 2(3), 306-317. https://doi.org/10.17681/HSP.96963

    BACKGROUND
  • Bakır, N., & Sarızayim, Ş. (2020). The relationship between psychosocial health and prenatal attachment in pregnant women. Perinatal Journal , 28(2), 73-81. https://doi.org/10.2399/prn.20.0282006

    BACKGROUND
  • Karakas NM, Dagli FS. The importance of attachment in infant and influencing factors. Turk Pediatri Ars. 2019 Jul 11;54(2):76-81. doi: 10.14744/TurkPediatriArs.2018.80269. eCollection 2019.

    PMID: 31384141BACKGROUND
  • McNamara J, Townsend ML, Herbert JS. A systemic review of maternal wellbeing and its relationship with maternal fetal attachment and early postpartum bonding. PLoS One. 2019 Jul 25;14(7):e0220032. doi: 10.1371/journal.pone.0220032. eCollection 2019.

    PMID: 31344070BACKGROUND
  • Alan Dikmen, H., & Çankaya, S. (2018). Maternal Obezitenin Prenatal Bağlanma Üzerine Etkisi. Acibadem Universitesi Saglik Bilimleri Dergisi, 9(2), 118-123. https://doi.org/10.31067/0.2018.1

    BACKGROUND
  • Alkaş, Ü., & Varışoğlu, Y. (2023). Primipar Gebelerde Anksiyete ve Prenatal Bağlanma: Pandemi Sürecinin Etkileri. Journal of Women's Health Nursing Jowhen , 9(1), 1-11. https://dergipark.org.tr/en/pub/kashed/issue/76497/1203330

    BACKGROUND
  • Bilgin, Z., & Ecevit Alpar, Ş. (2018). Kadınların Maternal Bağlanma Algısı ve Anneliğe İlişkin Görüşleri . Journal of Health Science and Profession, 5(1), 6-15. https://doi.org/10.17681/HSP.296664

    BACKGROUND
  • Şimşek, H. N., & Bolsoy, N. (2018). Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi " Gönderim " Sosyal Destek Sistemleri ve Ebelik. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi, 8(2), 97-103. https://dergipark.org.tr/en/pub/duzcesbed/issue/37762/338959?publisher=duzce

    BACKGROUND
  • Kınık, E., & Özcan, H. (2020). Maternal Bağlanmayı Etkileyen Faktörler ve Primiparlarda Maternal Bağlanma Durumu. Journal of Health Profession Research, 2(1), 47-53. https://dergipark.org.tr/en/pub/jhpr/issue/52597/596869

    BACKGROUND
  • Aktulay, A., Üstün, Y. E., Eyi, E. G. Y., Yörük, Ö., Hançerlioğulları, N., & Mollamahmutoğlu, L. (2013). Nonreaktif Nst Ön Tanısının Düşük Riskli Gebeliklerde Değerlendirilmesi. Jinekoloji-Obstetrik ve Neonatoloji Tıp Dergisi, 10(37), 1542-1545. https://dergipark.org.tr/en/pub/jgon/issue/51917/676229

    BACKGROUND
  • Kuru İyidir, Z. (2021). Non-Stress Teste Yönelik Verilen Eğitimin Gebelerin Kaygı Düzeyine Etkisi [Yüksek Lisans Tezi]. Aydın Adnan Menderes Üniversitesi Sağlık Bilimleri Enstitüsü.

    BACKGROUND
  • Çoban, M. (2022). Non Stres Test Esnasında Sanal Gözlük Kullanımının Kaygı, Stres Ve Fetal İyilik Üzerine Etkisi. [Yüksek Lisans Tezi]. İnönü Üniversitesi Sağlık Bilimleri Fakültesi.

    BACKGROUND
  • Hoca Nacar, E., & Gökkaya, F. (2019). Bağlanma ve Maternal Bağlanma Konusunda Bir Derleme. Cyprus Turkish Journal of Psychiatry and Psychology, 1(1), 49-55. https://doi.org/10.35365/ctjpp.19.1.06

    BACKGROUND
  • Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.

    PMID: 19897823BACKGROUND
  • Cohen, J. (1988). The t test for means. Statistical Power Analysis For the Behavioural Sciences . (N. Hillsdale, Ed.; 2. bs).

    BACKGROUND
  • Polit, D., & Beck, C. (2017). Nursing research: Generating and assessing evidence for nursing practice (10th ed.). PA: Lippincott Williams & Wilkins.

    BACKGROUND

Study Officials

  • Hilal Özbek

    Tokat Gaziosmanpasa Universty

    PRINCIPAL INVESTIGATOR
  • Nil Şevval Demir, Student

    Tokat Gaziosmanpasa Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

March 16, 2024

First Posted

March 26, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations