Menstrual Wellbeing in Woman Living in Turkey; an Epidemi... | NCT05442541

Studies
Menstrual Wellbeing in Woman Living in Turkey; an Epidemiological Study

NCT05442541

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Status

Completed

Last Update Posted

Jul 5, 2022Actual

Enrollment

1,829Actual

Phase

Not provided

Conditions

Menstrual Problem
Quality of Life

Interventions

not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Feb 1, 2022Actual

Completion Date

Feb 1, 2022Actual

First Submitted Date

Jan 12, 2022

First Submission Date that Met QC Criteria

Jun 30, 2022

First Posted Date

Jul 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2022

Last Update Posted Date

Jul 5, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elif Cansu Gundogdu, Principal Investigator, Dr. Lutfi Kirdar Kartal Training and Research HospitalPrincipal Investigator

Lead Sponsor

Dr. Lutfi Kirdar Kartal Training and Research HospitalOTHER_GOV

Collaborators

Name	Class
Turkish Endometriosis and Adenomyosis Society	UNKNOWN
IPSOS	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Women with endometriosis in our country and around the world face various difficulties during their menstrual periods in reproductive age. While some of these difficulties are caused by the environment, some of them are due to the insufficient development of personal consciousness. In our study, we aim to reveal the perspective of individuals and society on the menstrual period. Our primary aim in our study is to understand what kind of problems are experienced in different regions of our country during the menstrual period for women and how they are spent. Secondly, the effect of this period on women's quality of life will be examined.

Detailed Description

Our research will be conducted between January 1, 2022, and February 1, 2022, in 7 different regions of our country, by asking questions to women of reproductive age from different groups. Each participant will be asked to answer the survey questions and the results will be analyzed. The survey will be done face to face. The questionnaire contains questions about women's socio-demographic data, their perspectives on their menstrual period, their information about endometriosis, and their perspectives on pads and birth control pills. Menstruating women of reproductive age between the ages of 18- 45 will be included in this study. As a result of the study, the problems experienced by women of reproductive age in different regions will be evaluated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,829Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
not included any interventions(Evaluation of menstrual well-being in women of reproductive age, field survey study)	Behavioral	This is a prospective cross-sectional analytical study conducted through a questionnaire.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disparities in menstrual hygiene and well-being between 7 regions of Turkey in women of reproductive age with a questionnaire	In this study, the effect of the menstrual period on the quality of life of 1829 women living in seven different geographical regions of our country will be examined through a questionnaire. The goal of this study is to evaluate the menstrual well-being of women living in different regions of our country.	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.

Exclusion Criteria:

Women with a history of hematological disease, cardiovascular disease, malignancy, advanced renal failure, active infection, diabetes mellitus, and pregnant women will not be included in the study.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Menstruating women of reproductive age between the ages of 18- 45 will be included in this study

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Menstruating women of reproductive age between the ages of 18- 45 will be included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmet Kale, Prof.Dr.	Kartal Dr. Lutfi Kirdar Research and Training Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kartal Dr. Lutfi Kirdar Research and Training Hospital		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

not decided yet.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008599	Menstruation Disturbances
D004715	Endometriosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided