xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027281</url>
    </required_header>
    <id_info>
      <org_study_id>Consequences of FGM</org_study_id>
      <nct_id>NCT06027281</nct_id>
    </id_info>
    <brief_title>Consequences of Female Genital Mutilation on Married Women.</brief_title>
    <official_title>Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To assess psychiatric, social and sexual consequences of female genital mutilation on married&#xD;
        women.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        World Health Organization (WHO) defined female genital mutilation (FGM) as ''all procedures&#xD;
        that involve partial or total removal of the external female genitalia, or other injury to&#xD;
        the female genital organs for non-medical reasons.&#xD;
  &#xD;
        Many countries throughout the globe perform it: Western, Eastern, and North-Eastern Africa,&#xD;
        particularly Egypt and Ethiopia, and in parts of Asia and the Middle East (nearly half of its&#xD;
        cases are in Egypt and Ethiopia).&#xD;
  &#xD;
        Moreover, the prevalence of girls and women with FGM/C is also rising in Western countries&#xD;
        due to migration flows.&#xD;
  &#xD;
        The adverse physical consequences of female genital mutilation/cutting (FGM/C) have been&#xD;
        thoroughly investigated and documented. Yet, we know little about the adverse mental health&#xD;
        consequences of the practice.&#xD;
  &#xD;
        Also, few systematic reviews have addressed the impact of the practice on psycho-social&#xD;
        well-being, and there is limited understanding of what these consequences might consist.&#xD;
  &#xD;
        Throughout Egypt, many studies have been conducted to determine the pattern and prevalence of&#xD;
        FGM, but those studied the risks of FGM and its effect on women's sexual life are scare.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Hamilton depression rating scale (HDRS)</measure>
      <time_frame>From 10 to 15 minutes</time_frame>
      <description>To determine severity of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hamilton anxiety rating scale (HARS)</measure>
      <time_frame>From 10 to 15 minutes</time_frame>
      <description>To determine severity of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Screening for psychiatric symptoms.</measure>
      <time_frame>From 20 to 30 minutes</time_frame>
      <description>Mini international neuropsychiatric interview (MINI)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Screening for psychiatric symptoms.</measure>
      <time_frame>From 45 to 60 minutes</time_frame>
      <description>Minnesota Multiphasic personality Inventory (MMPI)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determination of socioeconomic class of the family.</measure>
      <time_frame>From 15 to 20 minutes</time_frame>
      <description>Family socioeconomic status scale (revised version 2019)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Screening for female sexual dysfunction.</measure>
      <time_frame>From 15 to 20 minutes</time_frame>
      <description>The female sexual function index (FSFI)</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Female Genital Mutilation</condition>
    <arm_group>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hamilton depression rating scale (HDRS)</intervention_name>
      <description>Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hamilton anxiety rating scale (HARS)</intervention_name>
      <description>Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mini international neuropsychiatric interview (MINI)</intervention_name>
      <description>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.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Minnesota Multiphasic personality Inventory (MMPI)</intervention_name>
      <description>The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The Symptom Check-List-90-R (SCL-90-R)</intervention_name>
      <description>The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify)</intervention_name>
      <description>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.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The female sexual function index (FSFI)</intervention_name>
      <description>The female sexual function index is a brief multidimensional scale for assessing sexual function in women.</description>
      <arm_group_label>Married women who didn't have female genital mutilation</arm_group_label>
      <arm_group_label>Married women who had female genital mutilation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Married women aged 18-50 years old.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Married females aged 18-50 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women who have any chronic disease as diabetes or hypertension.&#xD;
  &#xD;
            -  Women who have any physical or mental handicap.&#xD;
  &#xD;
            -  Women who have any psychiatric disorder prior to marriage.&#xD;
  &#xD;
            -  Women who refuse participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mariam Gamil Kamel</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wageh Abd El Nasser Hassan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mostafa Mahmoud Elnoamany, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut Univesity</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mariam Gamil Kamel</last_name>
      <phone>+20 01220133561</phone>
      <email>Mariam.20134348@med.aun.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wageh Abd El Nasser Hassan, PhD</last_name>
      <phone>+20 01227432194</phone>
      <email>wagehabdelnasser@yahoo.com</email>
    </overall_contact_backup>
    <results_reference>
      <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>
      <PMID>31406589</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>34098783</PMID>
    </results_reference>
    <results_reference>
      <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(2):191-208. doi: 10.1080/009262300278597.</citation>
      <PMID>10782451</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>26370845</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>11824839</PMID>
    </results_reference>
    <results_reference>
      <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. BMC Fam Pract. 2018 Jan 24;19(1):19. doi: 10.1186/s12875-017-0674-5.</citation>
      <PMID>29368585</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>17614093</PMID>
    </results_reference>
    <results_reference>
      <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/</citation>
      <PMID>32491457</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>10983482</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mariam Gamil Kamel</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Psychiatric</keyword>
    <keyword>Social</keyword>
    <keyword>Sexual</keyword>
    <keyword>Married</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027281
  org study id: Consequences of FGM
  nct id: NCT06027281
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess psychiatric, social and sexual consequences of female genital mutilation on married
        women.
  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.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Hamilton depression rating scale (HDRS)
  time frame: From 10 to 15 minutes
  description: To determine severity of anxiety.
  measure: Hamilton anxiety rating scale (HARS)
  time frame: From 10 to 15 minutes
  description: To determine severity of anxiety.
  measure: Screening for psychiatric symptoms.
  time frame: From 20 to 30 minutes
  description: Mini international neuropsychiatric interview (MINI)
  measure: Screening for psychiatric symptoms.
  time frame: From 45 to 60 minutes
  description: Minnesota Multiphasic personality Inventory (MMPI)
  measure: Determination of socioeconomic class of the family.
  time frame: From 15 to 20 minutes
  description: Family socioeconomic status scale (revised version 2019)
  measure: Screening for female sexual dysfunction.
  time frame: From 15 to 20 minutes
  description: The female sexual function index (FSFI)
  arm group label: Married women who had female genital mutilation
  arm group label: Married women who didn't have female genital mutilation
  intervention type: Other
  intervention name: Hamilton depression rating scale (HDRS)
  description: Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: Hamilton anxiety rating scale (HARS)
  description: Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: Mini international neuropsychiatric interview (MINI)
  description: 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.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: Minnesota Multiphasic personality Inventory (MMPI)
  description: The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: The Symptom Check-List-90-R (SCL-90-R)
  description: The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: Socioeconomic scale (A.El Gilany, A.El Wehady and M.El Wasify)
  description: 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.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  intervention type: Other
  intervention name: The female sexual function index (FSFI)
  description: The female sexual function index is a brief multidimensional scale for assessing sexual function in women.
  arm group label: Married women who didn't have female genital mutilation
  arm group label: Married women who had female genital mutilation
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mariam Gamil Kamel
  role: Study Director
  affiliation: Assiut University
  last name: Wageh Abd El Nasser Hassan, PhD
  role: Principal Investigator
  affiliation: Assiut University
  last name: Mostafa Mahmoud Elnoamany, PhD
  role: Principal Investigator
  affiliation: Assiut Univesity
  last name: Mariam Gamil Kamel
  phone: +20 01220133561
  email: Mariam.20134348@med.aun.edu.eg
  last name: Wageh Abd El Nasser Hassan, PhD
  phone: +20 01227432194
  email: wagehabdelnasser@yahoo.com
  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.
  PMID: 31406589
  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.
  PMID: 34098783
  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(2):191-208. doi: 10.1080/009262300278597.
  PMID: 10782451
  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.
  PMID: 26370845
  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.
  PMID: 11824839
  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. BMC Fam Pract. 2018 Jan 24;19(1):19. doi: 10.1186/s12875-017-0674-5.
  PMID: 29368585
  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.
  PMID: 17614093
  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/
  PMID: 32491457
  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.
  PMID: 10983482
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mariam Gamil Kamel
  investigator title: Principal investigator