Consequences of Female Genital Mutilation on Married Women.

NCT06027281 | Unknown

• 1 other identifier: Consequences of FGM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Female Genital Mutilation

Keywords

Psychiatric; Social; Sexual; Married

Outcome Measures

Primary Outcomes (6)

• Hamilton depression rating scale (HDRS)

  To determine severity of anxiety.

  From 10 to 15 minutes

• Hamilton anxiety rating scale (HARS)

  To determine severity of anxiety.

  From 10 to 15 minutes

• Screening for psychiatric symptoms.

  Mini international neuropsychiatric interview (MINI)

  From 20 to 30 minutes

• Screening for psychiatric symptoms.

  Minnesota Multiphasic personality Inventory (MMPI)

  From 45 to 60 minutes

• Determination of socioeconomic class of the family.

  Family socioeconomic status scale (revised version 2019)

  From 15 to 20 minutes

• Screening for female sexual dysfunction.

  The female sexual function index (FSFI)

  From 15 to 20 minutes

Study Arms (2)

Married women who had female genital mutilation

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)

Married women who didn't have female genital mutilation

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)

Interventions

Hamilton depression rating scale (HDRS) OTHER

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

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

Hamilton anxiety rating scale (HARS) OTHER

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

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

Mini international neuropsychiatric interview (MINI) 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.

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

Minnesota Multiphasic personality Inventory (MMPI) OTHER

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

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

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

The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory.

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify) 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.

Married women who didn't have female genital mutilation; Married women who had female genital mutilation

The female sexual function index (FSFI) 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; Married women who had female genital mutilation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Married women aged 18-50 years old.

You may qualify if:

• Married females aged 18-50 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 31406589 RESULT

• 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.

  PMID: 34098783 RESULT

• 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.

  PMID: 10782451 RESULT

• 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.

  PMID: 26370845 RESULT

• 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.

  PMID: 11824839 RESULT

• 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.

  PMID: 29368585 RESULT

• 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.

  PMID: 17614093 RESULT

• 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/

  PMID: 32491457 RESULT

• 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.

  PMID: 10983482 RESULT

MeSH Terms

Conditions

Coitus

Interventions

Psychiatric Status Rating Scales; MMPI

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Personality Inventory; Personality Tests

Study Officials

• Mariam Gamil Kamel

  Assiut University

  STUDY DIRECTOR

• Wageh Abd El Nasser Hassan, PhD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Mostafa Mahmoud Elnoamany, PhD

  Assiut Univesity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam Gamil Kamel

CONTACT

+20 01220133561; Mariam.20134348@med.aun.edu.eg

Wageh Abd El Nasser Hassan, PhD

CONTACT

+20 01227432194; wagehabdelnasser@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: September 7, 2023
• Study Start: November 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09