NewbornNCT04386798
Stress and Anxiety Levels of Mothers Lying in the Baby Newborn Intensive Care Unit
A study testing survey work in people with Newborn and Anxiety, run by Eskisehir Osmangazi University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- survey work
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jul 2020to 25 Dec 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Does not agree to participate in the research,
- readable and illiterate
- mothers with communication problems (who do not speak Turkish, etc.)
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Eskisehir City Hospital
Eskişehir, 26060
Eskisehir City Hospital
Odunpazari, Eskişehir, 26080
About this study
Official title: Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period
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.
Read the 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.
- Being tested
- survey work
- Keywords
- newborn intensive care, mother's anxiety, coronavirus pandemic
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey workOther
Bebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: survey work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers' anxiety rate
During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start25 Jul 2020
- Primary completion22 Dec 2020
- Study completion25 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK SAYIK, Eskisehir Osmangazi University
- Investigators
- DILEK SAYIK, expert nurse, Principal investigator, Eskisehir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386798
- Sponsor's protocol ID
- DSAYIK1
- Status last verified
- Mar 2022
- First submitted
- 6 May 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is completed and published in the journal, it will be shared
Publications
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.
PubMed 32167489Bedford 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.
PubMed 32197103T.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.
PubMed 32766539Ovalı, 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 at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Stress and Anxiety Levels of Mothers Lying in the Newborn Intensive Care Unit During Coronavirus Disease Pandemic Period
- ClinicalTrials.gov ID
- NCT04386798
- Acronym / sponsor ID
- DSAYIK1
- Keywords
- newborn intensive care, mother's anxiety, coronavirus pandemic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 25 Jul 2020 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 25 Dec 2021 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| survey application to mothers | Other | Other: survey workIn 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Does not agree to participate in the research,
- readable and illiterate
- mothers with communication problems (who do not speak Turkish, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| survey workBebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir. | Other | survey application to mothers |
Primary outcome
Mothers' anxiety rate
Time frame: 30 days
During Coronavirus disease pandemic, anxiety rates of mothers lying on their babies in their NICUs were correlated with sociodemographic features.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 32167489Casadevall 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.
- Background: PubMed 32197103Bedford 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.
- BackgroundT.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: PubMed 32766539Hu 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.
- BackgroundOvalı, F. (2020). Yenidoğanlarda COVID-19 Enfeksiyonları. Anadolu Kliniği Tıp Bilimleri Dergisi, 25(1), 23-45
- BackgroundTuran, 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.
- Individual participant dataSharing planned: Yes. When the study is completed and published in the journal, it will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DILEK SAYIK, expert nurse principal investigator
Eskisehir City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing survey work in people with Newborn and Anxiety, run by Eskisehir Osmangazi University at 2 sites 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 4 inclusion and 3 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Mothers' anxiety rate (time frame: 30 days). 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 NCT04386798, which also lists 6 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 31 Mar 2022.