Consequences of Female Genital Mutilation on Married Women.

Female Genital Mutilation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027281
• Other study ID #: Consequences of FGM
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: September 2023
• Source: Assiut University
• Contact: Mariam Gamil Kamel
• Phone: +20 01220133561
• Email: Mariam.20134348[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Genital Mutilation

Intervention

Other:
• Hamilton depression rating scale (HDRS)
Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.
• Hamilton anxiety rating scale (HARS)
Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.
• 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.
• Minnesota Multiphasic personality Inventory (MMPI)
The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.
• 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.
• 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.
• The female sexual function index (FSFI)
The female sexual function index is a brief multidimensional scale for assessing sexual function in women.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

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. — View Citation

Floyd AE, Gupta V. Minnesota Multiphasic Personality Inventory. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557525/ — View 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. — View Citation

Pettersson A, Modin S, Wahlstrom R, Af Winklerfelt Hammarberg S, Krakau I. The Mini-International Neuropsychiatric Interview is useful and well accepted as part of the clinical assessment for depression and anxiety in primary care: a mixed-methods study. — View Citation

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26( — View Citation

Schmitz N, Hartkamp N, Kiuse J, Franke GH, Reister G, Tress W. The Symptom Check-List-90-R (SCL-90-R): a German validation study. Qual Life Res. 2000 Mar;9(2):185-93. doi: 10.1023/a:1008931926181. — View Citation

Thompson E. Hamilton Rating Scale for Anxiety (HAM-A). Occup Med (Lond). 2015 Oct;65(7):601. doi: 10.1093/occmed/kqv054. No abstract available. — View Citation

van Vliet IM, de Beurs E. [The MINI-International Neuropsychiatric Interview. A brief structured diagnostic psychiatric interview for DSM-IV en ICD-10 psychiatric disorders]. Tijdschr Psychiatr. 2007;49(6):393-7. Dutch. — View Citation

Williams JB. Standardizing the Hamilton Depression Rating Scale: past, present, and future. Eur Arch Psychiatry Clin Neurosci. 2001;251 Suppl 2:II6-12. doi: 10.1007/BF03035120. — View Citation

Outcome

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