Consequences of Female Genital Mutilation on Married Women.

NCT ID: NCT06027281

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Female Genital Mutilation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Married women who had female genital mutilation

Hamilton depression rating scale (HDRS)

Intervention Type OTHER

Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.

Hamilton anxiety rating scale (HARS)

Intervention Type OTHER

Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.

Mini international neuropsychiatric interview (MINI)

Intervention Type OTHER

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)

Intervention Type OTHER

The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.

The Symptom Check-List-90-R (SCL-90-R)

Intervention Type OTHER

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)

Intervention Type OTHER

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)

Intervention Type OTHER

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

Hamilton depression rating scale (HDRS)

Intervention Type OTHER

Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.

Hamilton anxiety rating scale (HARS)

Intervention Type OTHER

Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.

Mini international neuropsychiatric interview (MINI)

Intervention Type OTHER

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)

Intervention Type OTHER

The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.

The Symptom Check-List-90-R (SCL-90-R)

Intervention Type OTHER

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)

Intervention Type OTHER

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)

Intervention Type OTHER

The female sexual function index is a brief multidimensional scale for assessing sexual function in women.

Interventions

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Hamilton depression rating scale (HDRS)

Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Minnesota Multiphasic personality Inventory (MMPI)

The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

The female sexual function index (FSFI)

The female sexual function index is a brief multidimensional scale for assessing sexual function in women.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Gamil Kamel

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mariam Gamil Kamel

Role: STUDY_DIRECTOR

Assiut University

Wageh Abd El Nasser Hassan, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mostafa Mahmoud Elnoamany, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiut Univesity

Central Contacts

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Mariam Gamil Kamel

Role: CONTACT

+20 01220133561

Wageh Abd El Nasser Hassan, PhD

Role: CONTACT

+20 01227432194

References

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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.

Reference Type RESULT
PMID: 31406589 (View on PubMed)

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.

Reference Type RESULT
PMID: 34098783 (View on PubMed)

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(2):191-208. doi: 10.1080/009262300278597.

Reference Type RESULT
PMID: 10782451 (View on PubMed)

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.

Reference Type RESULT
PMID: 26370845 (View on PubMed)

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.

Reference Type RESULT
PMID: 11824839 (View on PubMed)

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. BMC Fam Pract. 2018 Jan 24;19(1):19. doi: 10.1186/s12875-017-0674-5.

Reference Type RESULT
PMID: 29368585 (View on PubMed)

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.

Reference Type RESULT
PMID: 17614093 (View on PubMed)

Floyd AE, Gupta V. Minnesota Multiphasic Personality Inventory. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557525/

Reference Type RESULT
PMID: 32491457 (View on PubMed)

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.

Reference Type RESULT
PMID: 10983482 (View on PubMed)

Other Identifiers

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Consequences of FGM

Identifier Type: -

Identifier Source: org_study_id

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