Female Genital MutilationNCT06027281
Consequences of Female Genital Mutilation on Married Women.
An observational study of Female Genital Mutilation, run by Assiut University.
Trial summary
To assess psychiatric, social and sexual consequences of female genital mutilation on married women. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Genital Mutilation
- What is being tested?
- Hamilton depression rating scale (HDRS), Hamilton anxiety rating scale (HARS) and Mini international neuropsychiatric interview (MINI)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Married women aged 18-50 years old.
Who may be able to join
- Married females aged 18-50 years.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women
To assess psychiatric, social and sexual consequences of female genital mutilation on married women.
Read the 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.
- Conditions
- Female Genital Mutilation
- Being tested
- Hamilton depression rating scale (HDRS), Hamilton anxiety rating scale (HARS), Mini international neuropsychiatric interview (MINI), Minnesota Multiphasic personality Inventory (MMPI), The Symptom Check-List-90-R (SCL-90-R)
- Keywords
- Psychiatric, Social, Sexual, Married
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton depression rating scale (HDRS)Other
Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression.
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.
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.
Minnesota Multiphasic personality Inventory (MMPI)Other
The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology.
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.
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.
The female sexual function index (FSFI)Other
The female sexual function index is a brief multidimensional scale for assessing sexual function in women.
| Study group | Role | What they receive |
|---|---|---|
| Married women who had female genital mutilation | Not described Receives: 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 | Not described Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton depression rating scale (HDRS)
To determine severity of anxiety.
Measured: From 10 to 15 minutes
Hamilton anxiety rating scale (HARS)
To determine severity of anxiety.
Measured: From 10 to 15 minutes
Screening for psychiatric symptoms.
Mini international neuropsychiatric interview (MINI)
Measured: From 20 to 30 minutes
Screening for psychiatric symptoms.
Minnesota Multiphasic personality Inventory (MMPI)
Measured: From 45 to 60 minutes
Determination of socioeconomic class of the family.
Family socioeconomic status scale (revised version 2019)
Measured: From 15 to 20 minutes
Screening for female sexual dysfunction.
The female sexual function index (FSFI)
Measured: From 15 to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Female Genital MutilationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Gamil Kamel, Assiut University
- Investigators
- Mariam Gamil Kamel, Study director, Assiut UniversityWageh Abd El Nasser Hassan, PhD, Principal investigator, Assiut UniversityMostafa Mahmoud Elnoamany, PhD, Principal investigator, Assiut Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027281
- Sponsor's protocol ID
- Consequences of FGM
- Status last verified
- Sep 2023
- First submitted
- 18 Feb 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31406589O'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.
PubMed 34098783Rosen 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.
PubMed 10782451Thompson E. Hamilton Rating Scale for Anxiety (HAM-A). Occup Med (Lond). 2015 Oct;65(7):601. doi: 10.1093/occmed/kqv054. No abstract available.
PubMed 26370845Williams 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.
PubMed 11824839Pettersson 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.
PubMed 29368585van 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.
PubMed 17614093Floyd AE, Gupta V. Minnesota Multiphasic Personality Inventory. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557525/
PubMed 32491457Schmitz 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.
PubMed 10983482
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric, Social and Sexual Consequences of Female Genital Mutilation on Married Women
- ClinicalTrials.gov ID
- NCT06027281
- Acronym / sponsor ID
- Consequences of FGM
- Conditions
- Female Genital Mutilation
- Keywords
- Psychiatric, Social, Sexual, Married
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Married women aged 18-50 years old.
Key inclusion criteria (1 listed)
- Married females aged 18-50 years.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamilton depression rating scale (HDRS)Hamilton depression scale (HDRS) is the most commonly used instrument for assessing symptoms of depression. | Other | Married women who didn't have female genital mutilation, Married women who had female genital mutilation |
| Hamilton anxiety rating scale (HARS)Hamilton anxiety rating scale (HARS) is a 14-item clinician-rated measure of the severity of perceived anxiety symptoms. | Other | Married women who didn't have female genital mutilation, Married women who had female genital mutilation |
| 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. | Other | Married women who didn't have female genital mutilation, Married women who had female genital mutilation |
| Minnesota Multiphasic personality Inventory (MMPI)The Minnesota Multiphasic Personality Inventory (MMPI) is used to assess personality traits and psychopathology. | Other | 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)The Symptom Check-List-90-R (SCL-90-R) is a widely used psychological status symptom inventory. | Other | 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)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. | Other | Married women who didn't have female genital mutilation, Married women who had female genital mutilation |
| The female sexual function index (FSFI)The female sexual function index is a brief multidimensional scale for assessing sexual function in women. | Other | Married women who didn't have female genital mutilation, Married women who had female genital mutilation |
Primary outcome
Hamilton depression rating scale (HDRS)
Time frame: From 10 to 15 minutes
To determine severity of anxiety.
Hamilton anxiety rating scale (HARS)
Time frame: From 10 to 15 minutes
To determine severity of anxiety.
Screening for psychiatric symptoms.
Time frame: From 20 to 30 minutes
Mini international neuropsychiatric interview (MINI)
Screening for psychiatric symptoms.
Time frame: From 45 to 60 minutes
Minnesota Multiphasic personality Inventory (MMPI)
Determination of socioeconomic class of the family.
Time frame: From 15 to 20 minutes
Family socioeconomic status scale (revised version 2019)
Screening for female sexual dysfunction.
Time frame: From 15 to 20 minutes
The female sexual function index (FSFI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Results publication: PubMed 31406589Abdalla 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.
- Results publication: PubMed 34098783O'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.
- Results publication: PubMed 10782451Rosen 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.
- Results publication: PubMed 26370845Thompson E. Hamilton Rating Scale for Anxiety (HAM-A). Occup Med (Lond). 2015 Oct;65(7):601. doi: 10.1093/occmed/kqv054. No abstract available.
- Results publication: PubMed 11824839Williams 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.
- Results publication: PubMed 29368585Pettersson 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.
- Results publication: PubMed 17614093van 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.
- Results publication: PubMed 32491457Floyd AE, Gupta V. Minnesota Multiphasic Personality Inventory. 2023 Apr 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557525/
- Results publication: PubMed 10983482Schmitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam Gamil Kamel study director
Assiut University
Wageh Abd El Nasser Hassan, PhD principal investigator
Assiut University
Mostafa Mahmoud Elnoamany, PhD principal investigator
Assiut Univesity
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Mutilation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Gamil Kamel (+20 01220133561, Mariam.20134348@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton depression rating scale (HDRS) (time frame: From 10 to 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027281, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.