- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009902
Evaluation of Depression and Sleep Disorders in Endometriosis Patients
May 21, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively
The aim of this study was to compare the depression and sleep disturbances of operated endometriosis patients before and after the operation.
The main objective here is to provide data on how patients' psychological states and sleep patterns are affected by the symptoms of endometriosis and how these effects can be corrected.
In this way, it is aimed to determine whether the patients have psychological support needs and to give the planned treatment due to endometriosis in the early period.
As a secondary goal, it is planned to keep the patients in follow-up with their improved sleep and psychological conditions, and to improve their adherence to treatment and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 33404
- Kanuni Sultan Suleyman Training and Research Hospital
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Istanbul, Turkey
- Pınar Kadiroğulları
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The study group included patients with indications for operation and who agreed to test for depression and sleep disorders.
Description
Inclusion Criteria:
- 18-49 years of age with no known psychiatric disorder and
- Endometriosis patients with indications for operation
Exclusion Criteria:
- Patients receiving only medical treatment without any indication for operation,
- those with a known psychiatric disease,
- patients with sleep disorders due to another reason,
- Patients over the age of 49, patients under the age of 18,
- Patients with malignancy,
- pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Scale
Time Frame: 1 week
|
postoperative depression in endometriosis patients will be evaluated. Consists of 21 questions scored between 0-3. HIGH SCORE SHOWS TO HIGH DEPRESSION. (0-63 POINTS) |
1 week
|
|
Pittsburgh Sleep Quality Index
Time Frame: 1 week
|
postoperative sleep disorders of endometriosis patients will be evaluated. Consists of 9 questions scored between 0-3. HIGH SCORE SHOWS BAD SLEEP QUALITY. (0-27 POINTS) |
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 3, 2019
Primary Completion (Actual)
May 3, 2020
Study Completion (Actual)
May 3, 2020
Study Registration Dates
First Submitted
July 3, 2019
First Submitted That Met QC Criteria
July 3, 2019
First Posted (Actual)
July 5, 2019
Study Record Updates
Last Update Posted (Actual)
May 22, 2020
Last Update Submitted That Met QC Criteria
May 21, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.03.77
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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