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/NCT05998668</url>
    </required_header>
    <id_info>
      <org_study_id>2022/3782</org_study_id>
      <nct_id>NCT05998668</nct_id>
    </id_info>
    <brief_title>Genital Hygiene Training Provided to Turkish Women</brief_title>
    <official_title>The Effect of Genital Hygiene Training Provided to Turkish Women Living in Rural Areas With a Vulvovaginal Candidiasis History on Genital Hygiene Behaviors and Self-care Agency</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Inonu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Inonu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose: In the study, it was aimed to determine the effect of genital hygiene training&#xD;
        provided to women living in rural areas with a vulvovaginal candidiasis history on genital&#xD;
        hygiene behaviors and self-care agency.&#xD;
  &#xD;
        Material and methods: This study with a randomized controlled design was conducted with the&#xD;
        participation of women who were registered to Family Health Centers located in two villages&#xD;
        in the rural areas in the east of Turkey and who had a history of vulvovaginal candidiasis&#xD;
        within the last year. The study sample consisted of 114 women in total, 57 of whom were in&#xD;
        the intervention group and 57 were in the control group. The women in the intervention group&#xD;
        were provided with genital hygiene behaviors training. The study data were collected&#xD;
        Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency&#xD;
        Scale (SCAS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design The study was designed as a randomized controlled trial in which the subjects were&#xD;
        randomly assigned to the intervention (receiving genital hygiene training) and the control&#xD;
        group.&#xD;
  &#xD;
        The study was conducted in the Family Health Centers of two randomly selected villages with a&#xD;
        distance of 20-30 km to Van province located in the east of Turkey. These villages are in a&#xD;
        rural area and people make their living mostly through farming. Each village had one family&#xD;
        health center, and other health institutions were in the provincial center. Family health&#xD;
        centers are primary care health institutions which provide reproductive health service for&#xD;
        women (healthy woman follow-up, laboratory tests, family planning, education, counselling,&#xD;
        etc.). While training is provided within the scope of preventive health services in family&#xD;
        health centers, there is no training provided specifically on genital health regarding&#xD;
        vulvovaginal candidiasis. Working hours are between 08.00-17.00 every weekday, and there are&#xD;
        three family health doctors and three family health professionals (midwife and/or nurse) in&#xD;
        these centers.&#xD;
  &#xD;
        Sample The study sample consisted of women who tested positive on at least one culture test&#xD;
        and received and completed treatment for vulvovaginal candidiasis in the last year according&#xD;
        to the registry of the Family Health Centers. The study inclusion criteria were being within&#xD;
        the age range of 18-49 years, not having a systemic disease, and not being pregnant or&#xD;
        puerpera between the dates when the study was conducted. According to the registration system&#xD;
        of the family health centers, 1,400 women who met these criteria were receiving service from&#xD;
        these centers.&#xD;
  &#xD;
        In order to predict the most suitable sample size for the study, priori-power analysis was&#xD;
        performed on a web-based software (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html).&#xD;
        Sample size was calculated to be 57 for each group (57 in the intervention group and 57 in&#xD;
        the control group) with 5% margin of error at two-way significance level, 95% confidence&#xD;
        interval, 80% power of representing the population and by assuming that the mean score of&#xD;
        genital hygiene behaviors, which was 84.51 (standard deviation 5.69), would increase by three&#xD;
        points. According to the records of the family health centers where the study was conducted,&#xD;
        there were 142 women who received and completed treatment for vulvovaginal candidiasis in the&#xD;
        last six months. 142 women were assigned to the intervention and control groups through&#xD;
        randomization. Women were listed by the researchers for randomization. According to the list,&#xD;
        women with odd numbers were assigned to the intervention group and those with even numbers&#xD;
        were included in the control group. The sample selection process carried out in line with&#xD;
        CONSORT criteria is presented in Figure 1.&#xD;
  &#xD;
        Data Collection Tools In the collection of the study data, Identifying Information Form,&#xD;
        Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS) were used.&#xD;
  &#xD;
        Identifying Information Form: The form developed by reviewing the literature consisted of&#xD;
        questions inquiring about the sociodemographic characteristics of the women (age, educational&#xD;
        status, employment status, etc.).&#xD;
  &#xD;
        Genital Hygiene Behavior Inventory (GHBI): The scale was developed in Turkish in order to&#xD;
        measure genital hygiene behaviors of women, and the validity and reliability study of the&#xD;
        scale was conducted by Karahan in 2017. The scale consists of three subscales, which are&#xD;
        &quot;general hygiene&quot; (12 items), &quot;menstrual hygiene&quot; (8 items), and &quot;abnormal finding awareness&quot;&#xD;
        (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum&#xD;
        and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from&#xD;
        the scale increases, the women's levels of displaying proper genital hygiene behaviors&#xD;
        increase. The Cronbach's alpha internal consistency coefficient of the scale is 0.80.&#xD;
  &#xD;
        Self-Care Agency Scale (SCAS): The scale was developed by Kearney and Fleischer in 1979. The&#xD;
        Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used&#xD;
        to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert&#xD;
        type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the&#xD;
        scale are 0 and 140. A high score on the scale shows the individual's high level of self-care&#xD;
        agency. The Cronbach's alpha internal consistency of the scale is 0.89.&#xD;
  &#xD;
        Procedures The women assigned to the intervention and control groups were called on their&#xD;
        telephone numbers registered at the family health center by the researchers to inform them&#xD;
        about the study, and they were invited to the family health centers. The pretest data were&#xD;
        obtained from the women through the scales used in the study and the questionnaire on their&#xD;
        sociodemographic characteristics by face-to-face interviews held by the researchers in the&#xD;
        counselling room in the family health centers. Four weeks later, posttest data were collected&#xD;
        by following the same procedures.&#xD;
  &#xD;
        Following the pretest, &quot;genital hygiene behaviors training&quot; was provided to the women in the&#xD;
        intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure&#xD;
        prepared by the researchers which included the same content as the training was given to each&#xD;
        participant. The training program was carried out as oral instruction as well as using the&#xD;
        demonstration method which is called as &quot;tell-show-do&quot;. Individual questions of the women&#xD;
        were answered at the end of the training. In the first meeting with the women, 2 sessions of&#xD;
        45 minutes with a 10-minute break were held in the counselling rooms of the relevant family&#xD;
        health centers. Two weeks after these sessions, a 45-minute session was held in order to&#xD;
        reinforce the training with the same method. No intervention was made to the women in the&#xD;
        control group.&#xD;
  &#xD;
        Genital hygiene training program was developed by reviewing the literature, and expert&#xD;
        opinion was taken for content check before application. In line with the opinions of three&#xD;
        academics in the field of nursing, necessary corrections were made, and the training program&#xD;
        was finalized. The training program included introduction of reproductive organs, properties&#xD;
        of genital discharge, achieving hand and general hygiene, genital infections, hygiene rules&#xD;
        in sexual contact, ensuring genital hygiene during menstruation, problems related to genital&#xD;
        organs, and coping with genital problems.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 22, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">February 22, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>The study was desined as a randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Genital Hygiene Behavior Inventory (GHBI)</measure>
      <time_frame>Change from genital hygiene behavior levels at 4 weeks</time_frame>
      <description>The scale was developed in Turkish in order to measure genital hygiene behaviors of women, and the validity and reliability study of the scale was conducted by Karahan in 2017. The scale consists of three subscales, which are &quot;general hygiene&quot; (12 items), &quot;menstrual hygiene&quot; (8 items), and &quot;abnormal finding awareness&quot; (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from the scale increases, the women's levels of displaying proper genital hygiene behaviors increase.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Self-Care Agency Scale (SCAS)</measure>
      <time_frame>Change from self-care agency levels at 4 weeks</time_frame>
      <description>The scale was developed by Kearney and Fleischer in 1979. The Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the scale are 0 and 140. A high score on the scale shows the individual's high level of self-care agency.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">114</enrollment>
    <condition>Genital Hygiene</condition>
    <condition>Genital Hygiene Behaviors</condition>
    <condition>Self-care Agency</condition>
    <arm_group>
      <arm_group_label>genital hygiene training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following the pretest, &quot;genital hygiene behaviors training&quot; was provided to the women in the intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure prepared by the researchers which included the same content as the training was given to each participant. The training program was carried out as oral instruction as well as using the demonstration method which is called as &quot;tell-show-do&quot;. Individual questions of the women were answered at the end of the training. In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Four weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method. Four weeks after the data collection tools used in the research were filled in as a pre-test, post-test data were obtained with the same measurement tools.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine checks</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms (A sociodemographic questionnaire, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS). The post-test forms (GHBI, SCAS) were re-administered 4 weeks later to women who did not receive any intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Genital hygiene training</intervention_name>
      <description>In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Two weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method.</description>
      <arm_group_label>genital hygiene training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  women who tested positive on at least one culture test and received and treatment for&#xD;
               vulvovaginal candidiasis in the last year according to the registry of the Family&#xD;
               Health Centers, within the age range of 18-49 years, not having a systemic disease,&#xD;
               and not being pregnant or puerpera between the dates when the study was conducted.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who cannot communicate in Turkish, who are illiterate&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Women between the ages of 18-49 years</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>49 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Esra Sabanci Baransel</name>
        <address>
          <city>Malatya</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Inonu University</investigator_affiliation>
      <investigator_full_name>Esra SABANCI BARANSEL</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <keyword>genital hygiene</keyword>
    <keyword>vulvovaginal candidiasis</keyword>
    <keyword>genital infection</keyword>
    <keyword>self-care</keyword>
    <keyword>rural area</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Candidiasis</mesh_term>
      <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998668
  org study id: 2022/3782
  nct id: NCT05998668
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: In the study, it was aimed to determine the effect of genital hygiene training
        provided to women living in rural areas with a vulvovaginal candidiasis history on genital
        hygiene behaviors and self-care agency.
  
        Material and methods: This study with a randomized controlled design was conducted with the
        participation of women who were registered to Family Health Centers located in two villages
        in the rural areas in the east of Turkey and who had a history of vulvovaginal candidiasis
        within the last year. The study sample consisted of 114 women in total, 57 of whom were in
        the intervention group and 57 were in the control group. The women in the intervention group
        were provided with genital hygiene behaviors training. The study data were collected
        Identifying Information Form, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency
        Scale (SCAS).
  Design The study was designed as a randomized controlled trial in which the subjects were
        randomly assigned to the intervention (receiving genital hygiene training) and the control
        group.
  
        The study was conducted in the Family Health Centers of two randomly selected villages with a
        distance of 20-30 km to Van province located in the east of Turkey. These villages are in a
        rural area and people make their living mostly through farming. Each village had one family
        health center, and other health institutions were in the provincial center. Family health
        centers are primary care health institutions which provide reproductive health service for
        women (healthy woman follow-up, laboratory tests, family planning, education, counselling,
        etc.). While training is provided within the scope of preventive health services in family
        health centers, there is no training provided specifically on genital health regarding
        vulvovaginal candidiasis. Working hours are between 08.00-17.00 every weekday, and there are
        three family health doctors and three family health professionals (midwife and/or nurse) in
        these centers.
  
        Sample The study sample consisted of women who tested positive on at least one culture test
        and received and completed treatment for vulvovaginal candidiasis in the last year according
        to the registry of the Family Health Centers. The study inclusion criteria were being within
        the age range of 18-49 years, not having a systemic disease, and not being pregnant or
        puerpera between the dates when the study was conducted. According to the registration system
        of the family health centers, 1,400 women who met these criteria were receiving service from
        these centers.
  
        In order to predict the most suitable sample size for the study, priori-power analysis was
        performed on a web-based software (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html).
        Sample size was calculated to be 57 for each group (57 in the intervention group and 57 in
        the control group) with 5% margin of error at two-way significance level, 95% confidence
        interval, 80% power of representing the population and by assuming that the mean score of
        genital hygiene behaviors, which was 84.51 (standard deviation 5.69), would increase by three
        points. According to the records of the family health centers where the study was conducted,
        there were 142 women who received and completed treatment for vulvovaginal candidiasis in the
        last six months. 142 women were assigned to the intervention and control groups through
        randomization. Women were listed by the researchers for randomization. According to the list,
        women with odd numbers were assigned to the intervention group and those with even numbers
        were included in the control group. The sample selection process carried out in line with
        CONSORT criteria is presented in Figure 1.
  
        Data Collection Tools In the collection of the study data, Identifying Information Form,
        Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS) were used.
  
        Identifying Information Form: The form developed by reviewing the literature consisted of
        questions inquiring about the sociodemographic characteristics of the women (age, educational
        status, employment status, etc.).
  
        Genital Hygiene Behavior Inventory (GHBI): The scale was developed in Turkish in order to
        measure genital hygiene behaviors of women, and the validity and reliability study of the
        scale was conducted by Karahan in 2017. The scale consists of three subscales, which are
        "general hygiene" (12 items), "menstrual hygiene" (8 items), and "abnormal finding awareness"
        (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum
        and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from
        the scale increases, the women's levels of displaying proper genital hygiene behaviors
        increase. The Cronbach's alpha internal consistency coefficient of the scale is 0.80.
  
        Self-Care Agency Scale (SCAS): The scale was developed by Kearney and Fleischer in 1979. The
        Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used
        to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert
        type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the
        scale are 0 and 140. A high score on the scale shows the individual's high level of self-care
        agency. The Cronbach's alpha internal consistency of the scale is 0.89.
  
        Procedures The women assigned to the intervention and control groups were called on their
        telephone numbers registered at the family health center by the researchers to inform them
        about the study, and they were invited to the family health centers. The pretest data were
        obtained from the women through the scales used in the study and the questionnaire on their
        sociodemographic characteristics by face-to-face interviews held by the researchers in the
        counselling room in the family health centers. Four weeks later, posttest data were collected
        by following the same procedures.
  
        Following the pretest, "genital hygiene behaviors training" was provided to the women in the
        intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure
        prepared by the researchers which included the same content as the training was given to each
        participant. The training program was carried out as oral instruction as well as using the
        demonstration method which is called as "tell-show-do". Individual questions of the women
        were answered at the end of the training. In the first meeting with the women, 2 sessions of
        45 minutes with a 10-minute break were held in the counselling rooms of the relevant family
        health centers. Two weeks after these sessions, a 45-minute session was held in order to
        reinforce the training with the same method. No intervention was made to the women in the
        control group.
  
        Genital hygiene training program was developed by reviewing the literature, and expert
        opinion was taken for content check before application. In line with the opinions of three
        academics in the field of nursing, necessary corrections were made, and the training program
        was finalized. The training program included introduction of reproductive organs, properties
        of genital discharge, achieving hand and general hygiene, genital infections, hygiene rules
        in sexual contact, ensuring genital hygiene during menstruation, problems related to genital
        organs, and coping with genital problems.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The study was desined as a randomized controlled trial
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Genital Hygiene Behavior Inventory (GHBI)
  time frame: Change from genital hygiene behavior levels at 4 weeks
  description: The scale was developed in Turkish in order to measure genital hygiene behaviors of women, and the validity and reliability study of the scale was conducted by Karahan in 2017. The scale consists of three subscales, which are "general hygiene" (12 items), "menstrual hygiene" (8 items), and "abnormal finding awareness" (3 items). The 23-item and 5-point Likert type scale is scored between 1 and 5. The minimum and maximum scores to be obtained from the scale are 23 and 115. As the score obtained from the scale increases, the women's levels of displaying proper genital hygiene behaviors increase.
  measure: Self-Care Agency Scale (SCAS)
  time frame: Change from self-care agency levels at 4 weeks
  description: The scale was developed by Kearney and Fleischer in 1979. The Turkish validity and reliability of the scale was conducted by Nahcivan in 1993. It is used to measure individuals' self-care agency levels. Each item of the 35-item and 5-point Likert type scale is scored between 0 ad 4. The minimum and maximum scores to be obtained from the scale are 0 and 140. A high score on the scale shows the individual's high level of self-care agency.
  arm group label: genital hygiene training
  arm group type: Experimental
  description: Following the pretest, "genital hygiene behaviors training" was provided to the women in the intervention group by E.S.B., one the researchers. In addition, a genital hygiene brochure prepared by the researchers which included the same content as the training was given to each participant. The training program was carried out as oral instruction as well as using the demonstration method which is called as "tell-show-do". Individual questions of the women were answered at the end of the training. In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Four weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method. Four weeks after the data collection tools used in the research were filled in as a pre-test, post-test data were obtained with the same measurement tools.
  arm group label: Routine checks
  arm group type: No Intervention
  description: The researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms (A sociodemographic questionnaire, Genital Hygiene Behavior Inventory (GHBI), and Self-Care Agency Scale (SCAS). The post-test forms (GHBI, SCAS) were re-administered 4 weeks later to women who did not receive any intervention.
  intervention type: Other
  intervention name: Genital hygiene training
  description: In the first meeting with the women, 2 sessions of 45 minutes with a 10-minute break were held in the counselling rooms of the relevant family health centers. Two weeks after these sessions, a 45-minute session was held in order to reinforce the training with the same method.
  arm group label: genital hygiene training
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Women between the ages of 18-49 years
  minimum age: 18 Years
  maximum age: 49 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Inonu University
  investigator full name: Esra SABANCI BARANSEL
  investigator title: Assistant professor
  mesh term: Candidiasis
  mesh term: Candidiasis, Vulvovaginal
  sharing ipd: No