COVIDNCT04384887
"Investigation of the Relationship Between New Coronary Virus Disease (COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"
An observational study of COVID and Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID, Anxiety, Depression, Postpartum
- What is being tested?
- covid-19 positive pregnant women
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2020to 26 Aug 2020
- Phase
- Observational
- 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
Study population: Pregnant women with a positive covid -19 pcr test between the ages of 18 and 45 will be included in the study and beck and anxiety tests will be performed 3 months after birth.
Who may be able to join
- covid -19 pcr positive pregnant women
- no psychiatric diagnosis no use of psychiatric medicine
Who cannot join
- Non-pregnant patients, A psychiatric diagnosis use of psychiatric medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"
In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned.
(Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms
17-29 points = moderate depressive symptoms
30-63 points = severe depressive symptoms
Read the detailed description
The sociodemographic data form prepared by the researchers will be filled out by interviewing the patients who are willing to participate in the study. In addition, Beck Depression Scale, Beck Anxiety Scale, State and Trait Anxiety Scale will be given by the participants themselves. When the patients come to their first control after discharge, the scales specified will be repeated.
- Conditions
- COVID, Anxiety, Depression, Postpartum
- Being tested
- covid-19 positive pregnant women
- Medical subject headings
- Anxiety Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid-19 positive pregnant womenBehavioural
Also called covid-19 negative pregnant women
It is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19.
Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of depression and anxiety score changes of covid-19 positive pregnants
Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start25 Apr 2020
- Primary completion25 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ayşegül Bestel, İbrahim Polat, Merve Aldıkaçtıoğlu Talmaç
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384887
- Sponsor's protocol ID
- beckcovid
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ''(COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"
- ClinicalTrials.gov ID
- NCT04384887
- Acronym / sponsor ID
- beckcovid
- Conditions
- COVID, Anxiety, Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ayşegül Bestel, İbrahim Polat, Merve Aldıkaçtıoğlu Talmaç
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 12 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.
In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned.
(Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms
17-29 points = moderate depressive symptoms
30-63 points = severe depressive symptoms
Detailed description
The sociodemographic data form prepared by the researchers will be filled out by interviewing the patients who are willing to participate in the study. In addition, Beck Depression Scale, Beck Anxiety Scale, State and Trait Anxiety Scale will be given by the participants themselves. When the patients come to their first control after discharge, the scales specified will be repeated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with a positive covid -19 pcr test between the ages of 18 and 45 will be included in the study and beck and anxiety tests will be performed 3 months after birth.
Key inclusion criteria (2 listed)
- covid -19 pcr positive pregnant women
- no psychiatric diagnosis no use of psychiatric medicine
Key exclusion criteria (1 listed)
- Non-pregnant patients, A psychiatric diagnosis use of psychiatric medicine
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 |
|---|---|---|
| covid-19 positive pregnant womenAlso: covid-19 negative pregnant womenIt is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19. Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period. | Behavioural | – |
Primary outcome
Evaluation of depression and anxiety score changes of covid-19 positive pregnants
Time frame: 4 months
Evaluation of depression and anxiety score changes of covid-19 positive pregnants Pregnant women are questioned how this period was affected, as the pandemic period loaded with extra stress and caused depression and anxiety.
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 2 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID and Anxiety, run by Kanuni Sultan Suleyman Training and Research Hospital 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 2 inclusion and 1 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 2 Sep 2020. 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?
Evaluation of depression and anxiety score changes of covid-19 positive pregnants (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2020.