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

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
      • Istanbul, Turkey
        • Pınar Kadiroğulları

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

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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