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Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit

Primary Purpose

Newborn, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
survey work
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Newborn focused on measuring newborn intensive care, mother's anxiety, coronavirus pandemic

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.)

Sites / Locations

  • Eskisehir City Hospital
  • Eskisehir City Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

survey application to mothers

Arm Description

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.

Outcomes

Primary Outcome Measures

Mothers' anxiety rate
During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
March 30, 2022
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04386798
Brief Title
Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit
Official Title
Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 25, 2020 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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), SARS-CoV-2, and has made a worldwide pandemic from the beginning of 2020. 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. In the period when the feeling of motherhood begins at the end of birth, the hospitalization of the baby for any reason and the separation of the mother and the baby can be an additional source of stress. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn, Anxiety
Keywords
newborn intensive care, mother's anxiety, coronavirus pandemic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
survey application to mothers
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
survey work
Intervention Description
Bebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir.
Primary Outcome Measure Information:
Title
Mothers' anxiety rate
Description
During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DILEK SAYIK, expert nurse
Organizational Affiliation
Eskisehir City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskisehir City Hospital
City
Odunpazarı
State/Province
Eskisehir
ZIP/Postal Code
26080
Country
Turkey
Facility Name
Eskisehir City Hospital
City
Eskisehir
ZIP/Postal Code
26060
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
When the study is completed and published in the journal, it will be shared
IPD Sharing Time Frame
When the study is completed and published in the journal, it will be shared
Citations:
PubMed Identifier
32167489
Citation
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.
Results Reference
background
PubMed Identifier
32197103
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
32766539
Citation
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.
Results Reference
background
Citation
Ovalı, F. (2020). Yenidoğanlarda COVID-19 Enfeksiyonları. Anadolu Kliniği Tıp Bilimleri Dergisi, 25(1), 23-45
Results Reference
background
Citation
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.
Results Reference
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Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit

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