- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386798
Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit
Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period
Study Overview
Detailed Description
Although coronaviruses (CoV) cause mild infections in the community, such as colds, they can also cause more severe infections. There are many subspecies of coronaviruses that can pass from animals to humans and can be transmitted between humans. One of these subspecies is COVID-19 (severe acute respiratory syndrome coronavirus 2), or SARS-CoV-2, and has made a worldwide pandemic from the beginning of 2020. Many countries are taking measures to protect everyone, including those in the risk group, to prevent disease in large groups and balance hospital bed capacities against the COVID-19 pandemic. Among these measures; There is an incentive for public health practices such as contact isolation, quarantine, frequent hand washing, not going out of the house unless needed, and social distance. In the investigator's country, preventive and therapeutic measures (such as quarantine, social distance) are taken against the COVID-19 pandemic and the public is constantly informed in this context. In this process, going out of the house, going to the hospital and being in the hospital brings with it the anxiety to get sick. Despite all these, there are compulsory situations requiring people to be in the hospital during the pandemic period. One of them is to give birth and then the baby stays in the hospital due to the need for intensive care.
Although it is a pleasant feeling for women who have just given birth to feel the feeling of motherhood, to embrace the baby, to attach it to the baby, adapting to the new situation with the accompanying responsibilities can force the mother psychologically In the period when the feeling of motherhood begins, the hospitalization of the baby for any reason and the separation of the mother and the baby may be an additional source of stress. The fact that this process is experienced during the pandemic period can increase the anxiety and stress in the mother much more. It is important for nurses to determine the needs of mothers whose babies are in the neonatal intensive care unit (NICU) during their pandemic, in order to reduce their anxiety and anxiety by applying appropriate nursing approach. This study was planned to determine the anxiety and anxiety levels of mothers who had a baby in the NICU during Coronavirus disease pandemic and the factors affecting them.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eskisehir, Turkey, 26060
- Eskisehir City Hospital
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Eskisehir
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Odunpazarı, Eskisehir, Turkey, 26080
- Eskisehir City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mothers whose babies are lying in YYBÜ,
- Agree to participate in the study,
- without communication problems (who can speak Turkish ... etc.)
- Mothers who can read and write
Exclusion Criteria:
- Does not agree to participate in the research,
- readable and illiterate
- mothers with communication problems (who do not speak Turkish, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: survey application to mothers
In the neonatal intensive care, the information form, postpartum specific anxiety scale, and neonatal intensive care unit parent-father stress scale will be filled in for the mothers who have a baby.
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Bebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mothers' anxiety rate
Time Frame: 30 days
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During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.
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30 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DILEK SAYIK, expert nurse, Eskisehir City Hospital
Publications and helpful links
General Publications
- Bedford J, Enria D, Giesecke J, Heymann DL, Ihekweazu C, Kobinger G, Lane HC, Memish Z, Oh MD, Sall AA, Schuchat A, Ungchusak K, Wieler LH; WHO Strategic and Technical Advisory Group for Infectious Hazards. COVID-19: towards controlling of a pandemic. Lancet. 2020 Mar 28;395(10229):1015-1018. doi: 10.1016/S0140-6736(20)30673-5. Epub 2020 Mar 17. No abstract available.
- Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.
- T.C. Sağlık Bakanlığı COVID-19 (SARS-CoV-2 Enfeksiyonu) Rehberi Bilim Kurulu Çalışması 14.04.2020, https://covid19bilgi.saglik.gov.tr/depo/rehberler/COVID-19_Rehberi.pdf.
- Hu D, Kong Y, Li W, Han Q, Zhang X, Zhu LX, Wan SW, Liu Z, Shen Q, Yang J, He HG, Zhu J. Frontline nurses' burnout, anxiety, depression, and fear statuses and their associated factors during the COVID-19 outbreak in Wuhan, China: A large-scale cross-sectional study. EClinicalMedicine. 2020 Jun 27;24:100424. doi: 10.1016/j.eclinm.2020.100424. eCollection 2020 Jul.
- Ovalı, F. (2020). Yenidoğanlarda COVID-19 Enfeksiyonları. Anadolu Kliniği Tıp Bilimleri Dergisi, 25(1), 23-45
- Turan, T., & Başbakkal, Z. (2006). Yenidoğan yoğun bakım ünitesi anne-baba stres ölçeğinin geçerlilik ve güvenilirlik çalışması. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 13(2), 32-42.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- DSAYIK1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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