- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06331949
Video Supported Training on Non-Stress Test Application to Pregnant Women
The Effect of Video-Assisted Training Given to Pregnant Women on Non-Stress Test Application on Pregnancy Stress and Prenatal Attachment
Study Overview
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tokat, Turkey, 60250
- Tokat Gaziosmanpasa University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
|
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.
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No Intervention: Control Group
No additional applications will be made
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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State-Trait Anxiety Scale
Time Frame: Baseline]
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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.
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Baseline]
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Prenatal Attachment Inventory (PAI)
Time Frame: Baseline]
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Scale
Time Frame: after training is completed
|
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
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Prenatal Attachment Inventory (PAI)
Time Frame: after training is completed
|
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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State-Trait Anxiety Scale
Time Frame: two weeks after training is completed
|
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
|
|
Prenatal Attachment Inventory (PAI)
Time Frame: two weeks after training is completed
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilal Özbek, Tokat Gaziosmanpaşa Universty
- Principal Investigator: Nil Şevval Demir, Student, Tokat Gaziosmanpaşa Universty
Publications and helpful links
General Publications
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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.
- 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
- 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
- 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
- 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
- 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
- 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
- Kuru İyidir, Z. (2021). Non-Stress Teste Yönelik Verilen Eğitimin Gebelerin Kaygı Düzeyine Etkisi [Yüksek Lisans Tezi]. Aydın Adnan Menderes Üniversitesi Sağlık Bilimleri Enstitüsü.
- 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.
- 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
- Cohen, J. (1988). The t test for means. Statistical Power Analysis For the Behavioural Sciences . (N. Hillsdale, Ed.; 2. bs).
- Polit, D., & Beck, C. (2017). Nursing research: Generating and assessing evidence for nursing practice (10th ed.). PA: Lippincott Williams & Wilkins.
- Karakaş, N. M., & Dağlı, F. Ş. (2019). The importance of attachment in infant and influencing factors. Turkish Archives of Pediatrics/Türk Pediatri Arşivi, 54(2), 81. https://doi.org/10.14744/TURKPEDIATRIARS.2018.80269
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TR TOKAT02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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