Clinical trial NCT06027281: Consequences of Female Genital Mutilation on Married Women.
Official title: Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Female Genital Mutilation
Keywords: Psychiatric
Social
Sexual
Married
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Married women aged 18-50 years old.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton depression rating scale (HDRS)
timeFrame: From 10 to 15 minutes
measure: Hamilton anxiety rating scale (HARS)
timeFrame: From 10 to 15 minutes
measure: Screening for psychiatric symptoms.
timeFrame: From 20 to 30 minutes
measure: Screening for psychiatric symptoms.
timeFrame: From 45 to 60 minutes
measure: Determination of socioeconomic class of the family.
timeFrame: From 15 to 20 minutes
measure: Screening for female sexual dysfunction.
timeFrame: From 15 to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mariam Gamil Kamel
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Wageh Abd El Nasser Hassan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut Univesity
name: Mostafa Mahmoud Elnoamany, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdalla SM, Galea S. Is female genital mutilation/cutting associated with adverse mental health consequences? A systematic review of the evidence. BMJ Glob Health. 2019 Jul 15;4(4):e001553. doi: 10.1136/bmjgh-2019-001553. eCollection 2019.
citation: O'Neill S, Pallitto C. The Consequences of Female Genital Mutilation on Psycho-Social Well-Being: A Systematic Review of Qualitative Research. Qual Health Res. 2021 Jul;31(9):1738-1750. doi: 10.1177/10497323211001862. Epub 2021 Jun 8.
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