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First PregnancyNCT06331949

Video Supported Training on Non-Stress Test Application to Pregnant Women

A study testing video assisted training in people with First Pregnancy, run by Hilal Özbek at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
First Pregnancy
What is being tested?
video assisted training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Tokat Gaziosmanpasa University

    Tokat Province, 60250

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Video-Assisted Training Given to Pregnant Women on Non-Stress Test Application on Pregnancy Stress and Prenatal Attachment

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

Read the 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

Conditions
First Pregnancy
Being tested
video assisted training
Keywords
NST, prenatal attachment, video, education, State-Trait Anxiety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video assisted trainingOther

    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.

Study groups in NCT06331949
Study groupRoleWhat they receive
Experimental GroupExperimentalIn 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.
Receives: Other: video assisted training
Control GroupNo interventionNo additional applications will be made

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline]

  2. 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.

    Measured: Baseline]

Secondary outcomes (2)

  1. 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.

    Measured: after training is completed

  2. 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.

    Measured: after training is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Oct 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06331949
Sponsor's protocol ID
TR TOKAT02
Status last verified
May 2025
First submitted
16 Mar 2024
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33051530

  • 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

  • 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.

    PubMed 31384141

  • 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.

    PubMed 31344070

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing video assisted training in people with First Pregnancy, run by Hilal Özbek at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anxiety Scale (time frame: Baseline]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06331949, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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