NCT04386798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

May 6, 2020

Last Update Submit

March 30, 2022

Conditions

Keywords

newborn intensive caremother's anxietycoronavirus pandemic

Outcome Measures

Primary Outcomes (1)

  • Mothers' anxiety rate

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

    30 days

Study Arms (1)

survey application to mothers

OTHER

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.

Other: survey work

Interventions

Bebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir.

survey application to mothers

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Does not agree to participate in the research,
  • readable and illiterate
  • mothers with communication problems (who do not speak Turkish, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Eskisehir City Hospital

Odunpazari, Eskişehir, 26080, Turkey (Türkiye)

Location

Eskisehir City Hospital

Eskişehir, 26060, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 32167489BACKGROUND
  • 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.

    PMID: 32197103BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32766539BACKGROUND
  • Ovalı, F. (2020). Yenidoğanlarda COVID-19 Enfeksiyonları. Anadolu Kliniği Tıp Bilimleri Dergisi, 25(1), 23-45

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • DILEK SAYIK, expert nurse

    Eskisehir City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 13, 2020

Study Start

July 25, 2020

Primary Completion

December 22, 2020

Study Completion

December 25, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

When the study is completed and published in the journal, it will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
When the study is completed and published in the journal, it will be shared

Locations