EndometriosisNCT04337346
Evaluation of Covid 19 Anxiety in Endometriosis Patients
An observational study of Endometriosis and Covid19, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period. 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
- Endometriosis, Covid19
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2020to 25 Apr 2020
- How long will I take part?
- 20 Days
- 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: Evaluation of endometriosis patients anxiety and lifestyle during the covid 19 pandemic
Who may be able to join
- endometriosis patients
- no psychiatric illness
- no antidepressant use
Who cannot join
- women who had not endometriosis
- no extra health conditions
- women younger than 18 and older than 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endometriosis Patients Covid 19 Anxiety
It is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period.
- Conditions
- Endometriosis, Covid19
- Medical subject headings
- Endometriosis, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Covid 19 Anxiety levels in Endometriosis Patients
The Beck Anxiety Inventory (BAI); it measures the frequency of anxiety symptoms experienced by the patient. It consists of 21 questions in total. Each item gets an increasing score between 0-3. The total score ranges from 0 - 63. The following guidelines are recommended for the interpretation of scores: 0 -9, normal or no anxiety; 10 -18, mild to moderate anxiety; 19 -29, moderate to severe anxiety; and 30 - 63, severe anxiety.
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start5 Apr 2020
- Primary completion20 Apr 2020
- Study completion25 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- 80 participants (actual)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Yalcin bahat, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337346
- Sponsor's protocol ID
- endocovid19
- Status last verified
- May 2020
- First submitted
- 5 Apr 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis Patients Covid 19 Anxiety
- ClinicalTrials.gov ID
- NCT04337346
- Acronym / sponsor ID
- endocovid19
- Conditions
- Endometriosis, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 25 Apr 2020 (actual)
- First posted
- 7 Apr 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.
It is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Days
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Evaluation of endometriosis patients anxiety and lifestyle during the covid 19 pandemic
Key inclusion criteria (3 listed)
- endometriosis patients
- no psychiatric illness
- no antidepressant use
Key exclusion criteria (3 listed)
- women who had not endometriosis
- no extra health conditions
- women younger than 18 and older than 45
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Covid 19 Anxiety levels in Endometriosis Patients
Time frame: 20 days
The Beck Anxiety Inventory (BAI); it measures the frequency of anxiety symptoms experienced by the patient. It consists of 21 questions in total. Each item gets an increasing score between 0-3. The total score ranges from 0 - 63. The following guidelines are recommended for the interpretation of scores: 0 -9, normal or no anxiety; 10 -18, mild to moderate anxiety; 19 -29, moderate to severe anxiety; and 30 - 63, severe 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 20 May 2020.
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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 Endometriosis and Covid19, 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 3 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 20 May 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?
Covid 19 Anxiety levels in Endometriosis Patients (time frame: 20 days). 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 20 May 2020.