Urinary Tract InfectionsNCT06091670
Genital Hygiene Behaviors and Predicting Factors
An observational study of Urinary Tract Infections, run by Istanbul University - Cerrahpasa.
Trial summary
The aim of this study was to determine the genital hygiene practices of women in different regions of Turkey and the factors influencing these practices. It is a descriptive, cross-sectional study. The study was conducted according to the STROBE checklist. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- How many people
- 881 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2022to 15 Feb 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population of the study consisted of all women throughout Turkey, while the sample consisted of women who met the inclusion criteria of the study. The criteria for inclusion in the study are: (i) being able to read and understand Turkish, (ii) meeting the conditions for voluntary participation in the study. The sample consisted of 881 women reached online by the snowball sampling method
Who may be able to join
- Agreeing to participate in the study,
- To speak and understand Turkish,
- women
Who cannot join
- not being able to read and understand Turkish
- dont want to participate the research
About this study
Official title: Genital Hygiene Behaviors and Predicting Factors in Women Living in A Country: The Sample of Turkey
The aim of this study was to determine the genital hygiene practices of women in different regions of Turkey and the factors influencing these practices. It is a descriptive, cross-sectional study. The study was conducted according to the STROBE checklist.
Read the detailed description
The aim of this study was to determine the genital hygiene practices of women in different regions of Turkey and the factors influencing these practices. It is a descriptive, cross-sectional study.
Data Collection Tools Data for the study was collected through the "Data Collection Form" and "Genital Hygiene Behaviors Inventory", created by the researchers by reviewing the literature (Karahan, 2017; Cankaya, 2013; Elzayat et al. 2017; Adam and Saadia, 2016; Akgul, 2019).
Data collection form: A survey consisting of 13 questions about the age of the women, the amount of water consumed daily, the number of urinations, the genital infection status, and sexuality.
Genital Hygiene Behaviors Inventory - GHBI: A scale, developed by Karahan (2017), and for which written permission for use was obtained, consisting of 23 items in total and 3 sub-dimensions: "genital hygiene behaviors", "menstrual habits" and "abnormal findings". Items 1-12 evaluate genital hygiene, items 13-20 evaluate menstrual hygiene, and items 21-23 evaluate the awareness of abnormal findings. Items 7, 14, 19, 20 and 23 of the scale are the reversed items and are reverse coded during the evaluation. A minimum total of 23 and a maximum total of 115 points can be obtained from the 5-point Likert-type scale, where "1" point means "I totally disagree" and "5" points means "I completely agree". Higher scale scores correspond to better genital hygiene behaviors. The study evaluating the development of the scale and its validity and reliability determined the Cronbach's Alpha coefficient as 0.80 (Karahan, 2017); our study's Cronbach's Alpha coefficient was 0.78.
Data Collection The prepared data collection form and the scale were transferred to the computer environment and delivered online to the women through the snowball sampling method. It took approximately 10 minutes for each participant to complete the data collection forms Data Analysis The data collected in the study was analyzed using the Statistical Package for the Social Sciences, version 25.0 (SPSS, v25.0) statistical analysis package program (IBM Company, Turkey). First the descriptive data of the study was analyzed. Mean, median, standard deviation, minimum and maximum values were calculated in the analysis of continuous data, and numbers and percentages were calculated in the analysis of categorical data. Next, non-parametric and parametric tests were used according to normality distributions. Pearson Chi-square test, Kruskal Wallis Test and Mann Whitney-U tests were used to analyze the data. A simple linear regression analysis model was used to determine the factors affecting genital hygiene behaviors. Statistical significance level was accepted as p<.05 at 95% confidence interval.
- Conditions
- Urinary Tract Infections
- Being tested
- No intervention
- Keywords
- genital hygiene, female genital, hygiene behaviour, women's health
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention. The research is cross-sectional-descriptive type.
What is being measured
The primary outcome is the main question the study is designed to answer.
Genital Hygiene Behavior Inventory (GHBI)
Likert type inventory consisting of 27 questions evaluating genital hygiene behaviors.Inventory was applied to all pregnant women participating in the study at the beginning and at the end of the study.
Measured: 1 times
Data collection form:
This survey was created by the researchers according to the literature.6-9 The survey consisted of 13 questions about the sociodemographic features and the behaviors related genital tract infections.
Measured: 1 times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start7 Jul 2022
- Primary completion12 Nov 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 881 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Çalışkan, Istanbul University - Cerrahpasa
- Investigators
- Esra Çalışkan, Msc, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091670
- Sponsor's protocol ID
- ECaliskan1
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared
Publications
Emiru T, Beyene G, Tsegaye W, Melaku S. Associated risk factors of urinary tract infection among pregnant women at Felege Hiwot Referral Hospital, Bahir Dar, North West Ethiopia. BMC Res Notes. 2013 Jul 25;6:292. doi: 10.1186/1756-0500-6-292.
PubMed 23885968Minardi D, d'Anzeo G, Cantoro D, Conti A, Muzzonigro G. Urinary tract infections in women: etiology and treatment options. Int J Gen Med. 2011;4:333-43. doi: 10.2147/IJGM.S11767. Epub 2011 Apr 19.
PubMed 21674026Abdel-Aziz Elzayat M, Barnett-Vanes A, Dabour MF, Cheng F. Prevalence of undiagnosed asymptomatic bacteriuria and associated risk factors during pregnancy: a cross-sectional study at two tertiary centres in Cairo, Egypt. BMJ Open. 2017 Mar 21;7(3):e013198. doi: 10.1136/bmjopen-2016-013198.
PubMed 28325856Haider G, Zehra N, Munir AA, Haider A. Risk factors of urinary tract infection in pregnancy. J Pak Med Assoc. 2010 Mar;60(3):213-6.
PubMed 20225781Stapleton A, Stamm WE. Prevention of urinary tract infection. Infect Dis Clin North Am. 1997 Sep;11(3):719-33. doi: 10.1016/s0891-5520(05)70382-2.
PubMed 9378932
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genital Hygiene Behaviors and Predicting Factors in Women Living in A Country: The Sample of Turkey
- ClinicalTrials.gov ID
- NCT06091670
- Acronym / sponsor ID
- ECaliskan1
- Conditions
- Urinary Tract Infections
- Keywords
- genital hygiene, female genital, hygiene behaviour, women's health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 881 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 12 Nov 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 19 Oct 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.
The aim of this study was to determine the genital hygiene practices of women in different regions of Turkey and the factors influencing these practices. It is a descriptive, cross-sectional study. The study was conducted according to the STROBE checklist.
Detailed description
The aim of this study was to determine the genital hygiene practices of women in different regions of Turkey and the factors influencing these practices. It is a descriptive, cross-sectional study.
Data Collection Tools Data for the study was collected through the "Data Collection Form" and "Genital Hygiene Behaviors Inventory", created by the researchers by reviewing the literature (Karahan, 2017; Cankaya, 2013; Elzayat et al. 2017; Adam and Saadia, 2016; Akgul, 2019).
Data collection form: A survey consisting of 13 questions about the age of the women, the amount of water consumed daily, the number of urinations, the genital infection status, and sexuality.
Genital Hygiene Behaviors Inventory - GHBI: A scale, developed by Karahan (2017), and for which written permission for use was obtained, consisting of 23 items in total and 3 sub-dimensions: "genital hygiene behaviors", "menstrual habits" and "abnormal findings". Items 1-12 evaluate genital hygiene, items 13-20 evaluate menstrual hygiene, and items 21-23 evaluate the awareness of abnormal findings. Items 7, 14, 19, 20 and 23 of the scale are the reversed items and are reverse coded during the evaluation. A minimum total of 23 and a maximum total of 115 points can be obtained from the 5-point Likert-type scale, where "1" point means "I totally disagree" and "5" points means "I completely agree". Higher scale scores correspond to better genital hygiene behaviors. The study evaluating the development of the scale and its validity and reliability determined the Cronbach's Alpha coefficient as 0.80 (Karahan, 2017); our study's Cronbach's Alpha coefficient was 0.78.
Data Collection The prepared data collection form and the scale were transferred to the computer environment and delivered online to the women through the snowball sampling method. It took approximately 10 minutes for each participant to complete the data collection forms Data Analysis The data collected in the study was analyzed using the Statistical Package for the Social Sciences, version 25.0 (SPSS, v25.0) statistical analysis package program (IBM Company, Turkey). First the descriptive data of the study was analyzed. Mean, median, standard deviation, minimum and maximum values were calculated in the analysis of continuous data, and numbers and percentages were calculated in the analysis of categorical data. Next, non-parametric and parametric tests were used according to normality distributions. Pearson Chi-square test, Kruskal Wallis Test and Mann Whitney-U tests were used to analyze the data. A simple linear regression analysis model was used to determine the factors affecting genital hygiene behaviors. Statistical significance level was accepted as p<.05 at 95% confidence interval.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consisted of all women throughout Turkey, while the sample consisted of women who met the inclusion criteria of the study. The criteria for inclusion in the study are: (i) being able to read and understand Turkish, (ii) meeting the conditions for voluntary participation in the study. The sample consisted of 881 women reached online by the snowball sampling method
Key inclusion criteria (3 listed)
- Agreeing to participate in the study,
- To speak and understand Turkish,
- women
Key exclusion criteria (2 listed)
- not being able to read and understand Turkish
- dont want to participate the research
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 |
|---|---|---|
| No interventionThere is no intervention. The research is cross-sectional-descriptive type. | Other | – |
Primary outcome
Genital Hygiene Behavior Inventory (GHBI)
Time frame: 1 times
Likert type inventory consisting of 27 questions evaluating genital hygiene behaviors.Inventory was applied to all pregnant women participating in the study at the beginning and at the end of the study.
Data collection form:
Time frame: 1 times
This survey was created by the researchers according to the literature.6-9 The survey consisted of 13 questions about the sociodemographic features and the behaviors related genital tract infections.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 23885968Emiru T, Beyene G, Tsegaye W, Melaku S. Associated risk factors of urinary tract infection among pregnant women at Felege Hiwot Referral Hospital, Bahir Dar, North West Ethiopia. BMC Res Notes. 2013 Jul 25;6:292. doi: 10.1186/1756-0500-6-292.
- Background: PubMed 21674026Minardi D, d'Anzeo G, Cantoro D, Conti A, Muzzonigro G. Urinary tract infections in women: etiology and treatment options. Int J Gen Med. 2011;4:333-43. doi: 10.2147/IJGM.S11767. Epub 2011 Apr 19.
- Background: PubMed 28325856Abdel-Aziz Elzayat M, Barnett-Vanes A, Dabour MF, Cheng F. Prevalence of undiagnosed asymptomatic bacteriuria and associated risk factors during pregnancy: a cross-sectional study at two tertiary centres in Cairo, Egypt. BMJ Open. 2017 Mar 21;7(3):e013198. doi: 10.1136/bmjopen-2016-013198.
- Background: PubMed 20225781Haider G, Zehra N, Munir AA, Haider A. Risk factors of urinary tract infection in pregnancy. J Pak Med Assoc. 2010 Mar;60(3):213-6.
- Background: PubMed 9378932Stapleton A, Stamm WE. Prevention of urinary tract infection. Infect Dis Clin North Am. 1997 Sep;11(3):719-33. doi: 10.1016/s0891-5520(05)70382-2.
- Individual participant dataSharing planned: No. Research results will be shared
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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.
Esra Çalışkan, Msc study director
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections, run by Istanbul University - Cerrahpasa.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 19 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genital Hygiene Behavior Inventory (GHBI) (time frame: 1 times). The study lists 2 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 NCT06091670, which also lists 5 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 19 Oct 2023.