Evaluation of Depression and Sleep Disorders in Endometriosis Patients

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04009902
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Actual Duration (Months): 10
• Patients Per Site: 25
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis; Sleep; Depression	Behavioral: Beck Depression Scale and Pittsburgh Sleep Quality Index

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively
• Actual Study Start Date: Jul 3, 2019
• Actual Primary Completion Date: May 3, 2020
• Actual Study Completion Date: May 3, 2020

Outcome Measures

Primary Outcome Measures

1. Beck Depression Scale [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)

2. Pittsburgh Sleep Quality Index [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul		Turkey	33404
2	Pınar Kadiroğulları	Istanbul		Turkey

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pınar Kadirogulları, Principal investigator, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04009902
• Other Study ID Numbers: 2019.03.77
• First Posted: Jul 5, 2019
• Last Update Posted: May 22, 2020
• Last Verified: May 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Endometriosis; Depression; Depressive Disorder

Study Results

No Results Posted as of May 22, 2020