NCT04009902

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

10 months

First QC Date

July 3, 2019

Last Update Submit

May 21, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

postoperative depression and sleep disorders in patients with endometriosis will be evaluated

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study group included patients with indications for operation and who agreed to test for depression and sleep disorders.

You may qualify if:

  • years of age with no known psychiatric disorder and
  • Endometriosis patients with indications for operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

Pınar Kadiroğulları

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EndometriosisDepression

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 5, 2019

Study Start

July 3, 2019

Primary Completion

May 3, 2020

Study Completion

May 3, 2020

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations