Consequences of Female Genital Mutilation on Married Women.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06027281
Collaborator
(none)
100
9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Hamilton depression rating scale (HDRS)
  • Other: Hamilton anxiety rating scale (HARS)
  • Other: Mini international neuropsychiatric interview (MINI)
  • Other: Minnesota Multiphasic personality Inventory (MMPI)
  • Other: The Symptom Check-List-90-R (SCL-90-R)
  • Other: Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify)
  • Other: The female sexual function index (FSFI)

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Hamilton depression rating scale (HDRS) [From 10 to 15 minutes]

    To determine severity of anxiety.

  2. Hamilton anxiety rating scale (HARS) [From 10 to 15 minutes]

    To determine severity of anxiety.

  3. Screening for psychiatric symptoms. [From 20 to 30 minutes]

    Mini international neuropsychiatric interview (MINI)

  4. Screening for psychiatric symptoms. [From 45 to 60 minutes]

    Minnesota Multiphasic personality Inventory (MMPI)

  5. Determination of socioeconomic class of the family. [From 15 to 20 minutes]

    Family socioeconomic status scale (revised version 2019)

  6. Screening for female sexual dysfunction. [From 15 to 20 minutes]

    The female sexual function index (FSFI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mariam Gamil Kamel, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06027281
Other Study ID Numbers:
  • Consequences of FGM
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mariam Gamil Kamel, Principal investigator, Assiut University

Study Results

No Results Posted as of Sep 7, 2023