Evaluation of Depression and Sleep Disorders in Endometriosis Patients

Depression Clinical Trial

Official title:

Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009902
• Other study ID #: 2019.03.77
• Status: Completed
• Start date: July 3, 2019
• Est. completion date: May 3, 2020

Study information

• Verified date: May 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 3, 2020
• Est. primary completion date: May 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Endometriosis
• Parasomnias
• Sleep
• Sleep Wake Disorders

Intervention

Behavioral:
• Beck Depression Scale and Pittsburgh Sleep Quality Index
postoperative depression and sleep disorders in patients with endometriosis will be evaluated

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul
Turkey	Pinar Kadirogullari	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Scale	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
Primary	Pittsburgh Sleep Quality Index	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