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出境医 / 临床实验 / Evaluation of Depression and Sleep Disorders in Endometriosis Patients
Evaluation of Depression and Sleep Disorders in Endometriosis Patients
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 |
|---|---|
| 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 : | July 3, 2019 |
| Actual Primary Completion Date : | May 3, 2020 |
| Actual Study Completion Date : | May 3, 2020 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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)
- 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)
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 3, 2019 | ||||
| First Posted Date | July 5, 2019 | ||||
| Last Update Posted Date | May 22, 2020 | ||||
| Actual Study Start Date | July 3, 2019 | ||||
| Actual Primary Completion Date | May 3, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Evaluation of Depression and Sleep Disorders in Endometriosis Patients | ||||
| Official Title | Evaluation of Depression and Sleep Disorders in Endometriosis Patients Preoperatively and Postoperatively | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
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| Intervention | Behavioral: Beck Depression Scale and Pittsburgh Sleep Quality Index
postoperative depression and sleep disorders in patients with endometriosis will be evaluated
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
50 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Actual Study Completion Date | May 3, 2020 | ||||
| Actual Primary Completion Date | May 3, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 50 Years (Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Turkey | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04009902 | ||||
| Other Study ID Numbers | 2019.03.77 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Study Sponsor | Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | Kanuni Sultan Suleyman Training and Research Hospital | ||||
| Verification Date | May 2020 | ||||
