Consequences of Female Genital Mutilation on Married Women.

September 6, 2023 updated by: Mariam Gamil Kamel, Assiut University

Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women

To assess psychiatric, social and sexual consequences of female genital mutilation on married women.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

World Health Organization (WHO) defined female genital mutilation (FGM) as ''all procedures that involve partial or total removal of the external female genitalia, or other injury to the female genital organs for non-medical reasons.

Many countries throughout the globe perform it: Western, Eastern, and North-Eastern Africa, particularly Egypt and Ethiopia, and in parts of Asia and the Middle East (nearly half of its cases are in Egypt and Ethiopia).

Moreover, the prevalence of girls and women with FGM/C is also rising in Western countries due to migration flows.

The adverse physical consequences of female genital mutilation/cutting (FGM/C) have been thoroughly investigated and documented. Yet, we know little about the adverse mental health consequences of the practice.

Also, few systematic reviews have addressed the impact of the practice on psycho-social well-being, and there is limited understanding of what these consequences might consist.

Throughout Egypt, many studies have been conducted to determine the pattern and prevalence of FGM, but those studied the risks of FGM and its effect on women's sexual life are scare.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Married women aged 18-50 years old.

Description

Inclusion Criteria:

  • Married females aged 18-50 years.

Exclusion Criteria:

  • Women who have any chronic disease as diabetes or hypertension.
  • Women who have any physical or mental handicap.
  • Women who have any psychiatric disorder prior to marriage.
  • Women who refuse participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Married women who had female genital mutilation
Other: Hamilton depression rating scale (HDRS)
Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.
Other: Hamilton anxiety rating scale (HARS)
Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.
Other: Mini international neuropsychiatric interview (MINI)
The Mini International Neuropsychiatric Interview (MINI) was designed as a brief structured diagnostic interview for the major psychiatric disorders in DSM-III-R, DSM-IV and DSM-5 and ICD-10.
Other: Minnesota Multiphasic personality Inventory (MMPI)
The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.
Other: The Symptom Check-List-90-R (SCL-90-R)
The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory.
Other: Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify)
An Arabic version of the socioeconomic scale consisted of four dimensions, namely, level of education, employment, total family monthly income, and lifestyle of the family.
Other: The female sexual function index (FSFI)
The female sexual function index is a brief multidimensional scale for assessing sexual function in women.
Married women who didn't have female genital mutilation
Other: Hamilton depression rating scale (HDRS)
Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.
Other: Hamilton anxiety rating scale (HARS)
Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.
Other: Mini international neuropsychiatric interview (MINI)
The Mini International Neuropsychiatric Interview (MINI) was designed as a brief structured diagnostic interview for the major psychiatric disorders in DSM-III-R, DSM-IV and DSM-5 and ICD-10.
Other: Minnesota Multiphasic personality Inventory (MMPI)
The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.
Other: The Symptom Check-List-90-R (SCL-90-R)
The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory.
Other: Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify)
An Arabic version of the socioeconomic scale consisted of four dimensions, namely, level of education, employment, total family monthly income, and lifestyle of the family.
Other: The female sexual function index (FSFI)
The female sexual function index is a brief multidimensional scale for assessing sexual function in women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton depression rating scale (HDRS)
Time Frame: From 10 to 15 minutes
To determine severity of anxiety.
From 10 to 15 minutes
Hamilton anxiety rating scale (HARS)
Time Frame: From 10 to 15 minutes
To determine severity of anxiety.
From 10 to 15 minutes
Screening for psychiatric symptoms.
Time Frame: From 20 to 30 minutes
Mini international neuropsychiatric interview (MINI)
From 20 to 30 minutes
Screening for psychiatric symptoms.
Time Frame: From 45 to 60 minutes
Minnesota Multiphasic personality Inventory (MMPI)
From 45 to 60 minutes
Determination of socioeconomic class of the family.
Time Frame: From 15 to 20 minutes
Family socioeconomic status scale (revised version 2019)
From 15 to 20 minutes
Screening for female sexual dysfunction.
Time Frame: From 15 to 20 minutes
The female sexual function index (FSFI)
From 15 to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mariam Gamil Kamel, Assiut University
  • Principal Investigator: Wageh Abd El Nasser Hassan, PhD, Assiut University
  • Principal Investigator: Mostafa Mahmoud Elnoamany, PhD, assiut univesity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Consequences of FGM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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