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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06331949
Other study ID # TR TOKAT02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date November 1, 2024

Study information

Verified date March 2024
Source Tokat Gaziosmanpasa University
Contact Hilal Özbek, Dr
Phone 05053873773
Email h.ozzbek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

Background: NST may negatively affect the stress level and prenatal attachment level in primiparous pregnant women. Purpose: This study will be carried out to determine the effect of video-educated midwifery care given to primiparous pregnant women before NST application on pregnancy stress and prenatal attachment levels. Method: The data of the research will be collected at Tokat State Hospital after permission. During data collection, pregnant women who apply to the NST room of the relevant hospital and meet the inclusion criteria for the study will be informed about the researchers and the study. Written consent will be obtained from pregnant women who volunteer to participate in the study by filling out the "Informed Volunteer Consent Form". The training will be held in a suitable room (a quiet room where individuals can sit comfortably and see each other) in the area where the NST room is located in the hospital. Pregnant women will be informed about the purpose of the study, the confidentiality of the answers, where and how the data will be stored, and their questions on the subject will be answered. Data collection forms will be given to the participant by the researcher and they will be asked to fill them out. The data collection forms will be checked by the researcher to see if they have been filled out completely. This process is planned to take approximately 10-15 minutes. Experimental Group: 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. Control Group: No additional applications will be made


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
video assisted training
Ebelik bakiminin yani sira NST konusunda egitim içerikleri, egitim videolari ve brosür destekli egitimler verilecek. NST cihazi takilacak ve standart olarak islem basladiktan 5 dakika sonra NST kaydi sirasinda cihazdan gelen fetal kalp sesinin siddeti artirilarak fetal kalp sesinin devam etmesi saglanacaktir. Transfer edilecek hamile kadin yaklasik 2 dakika kadar dinlenecektir.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hilal Özbek

References & Publications (22)

Aksay, Y., Gülhan, Y. B., Saygin, N., & Körükçü, Ö. (2017). Gebelerin Psikososyal Sagliklari Dogum Tercihini Etkiler Mi? Gümüshane Üniversitesi Saglik Bilimleri Dergisi, 6(4), 138-145

Aktulay, A., Üstün, Y. E., Eyi, E. G. Y., Yörük, Ö., Hançerliogullari, N., & Mollamahmutoglu, L. (2013). Nonreaktif Nst Ön Tanisinin Düsük Riskli Gebeliklerde Degerlendirilmesi. Jinekoloji-Obstetrik ve Neonatoloji Tip Dergisi, 10(37), 1542-1545. https://dergipark.org.tr/en/pub/jgon/issue/51917/676229

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

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

Bakir, N., & Sarizayim, S. (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

Bilgin, Z., & Ecevit Alpar, S. (2018). Kadinlarin Maternal Baglanma Algisi ve Annelige Iliskin Görüsleri . Journal of Health Science and Profession, 5(1), 6-15. https://doi.org/10.17681/HSP.296664

Çoban, M. (2022). Non Stres Test Esnasinda Sanal Gözlük Kullaniminin Kaygi, Stres Ve Fetal Iyilik Üzerine Etkisi. [Yüksek Lisans Tezi]. Inönü Üniversitesi Saglik Bilimleri Fakültesi.

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

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. — View Citation

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

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

Kaloglu Bi?ni?ci?, D., & Köse Tuncer, S. (2020). Primipar ve Multipar Gebelerde Algilanan Stres ve Etkileyen Faktörlerin Incelenmesi. Ebelik ve Saglik Bilimleri Dergisi, 3(3), 189-202.

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. — View Citation

Kaya, D. (2021). Gebeligin Olusumu ve Fizyolojisi. Içinde Ö. Dogan Yüksekol, F. Evcili, & G. Doganer (Ed.), Normal gebelik ve bakim (1. bs, ss. 64-86). Ankara Nobel Tip Kitapevleri.

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

Kuru Iyidir, Z. (2021). Non-Stress Teste Yönelik Verilen Egitimin Gebelerin Kaygi Düzeyine Etkisi [Yüksek Lisans Tezi]. Aydin Adnan Menderes Üniversitesi Saglik Bilimleri Enstitüsü.

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. — View Citation

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. — View Citation

Özkan, H., & Mucuk, Ö. (2021). Gebelikte Ruh Sagliginda Meydana Gelen Degisimler ve Bakim. Içinde Ö. Dogan Yüksekol, F. Evcili, & G. Doganer (Ed.), Normal gebelik ve bakim (1. bs, ss. 175-184). Ankara Nobel Tip Kitapevleri.

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

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

Üst, Z. D., & Pasinlioglu, T. (2015). Primipar ve Multipar Gebelerde Dogum ve Postpartum Döneme Iliskin Endiselerin Belirlenmesi. Journal of Health Science and Profession, 2(3), 306-317. https://doi.org/10.17681/HSP.96963

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other 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. two weeks after training is completed
Other 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. two weeks after training is completed
Primary 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]
Primary 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 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. after training is completed
Secondary 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. after training is completed
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