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/NCT05984836</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00013620(9/19/2025)</org_study_id>
      <nct_id>NCT05984836</nct_id>
    </id_info>
    <brief_title>Home Injuries, Early Childhood, Rural Mothers, First Aid, Matrouh Governorate</brief_title>
    <official_title>Home-Related Injuries Among Early Childhood: Towards Rural Mothers' Knowledge, Attitudes and Practice Regarding First Aid in Matrouh Governorate, Egypt</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Matrouh University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Matrouh 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>
        Home-Related Injuries among Early Childhood: Rural Mothers' Knowledge, Attitudes and Practice&#xD;
        regarding First Aid in Matrouh Governorate, Egypt&#xD;
  &#xD;
        Keywords: Home injuries, Early childhood, Rural mothers, First aid, Matrouh Governorate.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Implement health education class to rural mothers about first aid measures to be taken for&#xD;
        their injured children&quot;&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 25, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Pre-postest of the knowledge, attitudes and practice (KAP) of rural mothers regarding first aid measures to be taken for injured children in Matrouh Governorate, Egypt.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mothers' Structured Interview Schedule</measure>
      <time_frame>one session will take about 30 minutes</time_frame>
      <description>This tool will be developed by the researcher after reviewing relevant literature to collect the required data from the mothers regarding first aid at home.&#xD;
  Part (1): 22-item questions to assess demographic data, measuring the percentage and types of children home injuries occurred during the past 4 months.&#xD;
  Part (2): 6-item questions to assess the knowledge of mothers about causes of home accidents in children. A modified part 1 and 2 structured questionnaire from (Bayomi and Mobarak, 2013; and El-Sabely et al, 2014) (6,10) was used&#xD;
  Part (3): 25-item questions to assess the practice and attitude of mothers towards home-related injuries. Eight negative and 17 positive items were developed (Likert scale rate).&#xD;
  Part 4: Mother's Subjective Practices regarding to first aid at home scale. This part will be developed by the researcher based on related literature (Network, 2009), (Fatouh et al., 2020), (KUMAR, SIDHU, &amp; ZABI, 2020).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Home Injury</condition>
    <arm_group>
      <arm_group_label>health education class</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implement health education class to rural mothers about first aid measures to be taken for injured children in Matrouh Governorate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Implement health education</intervention_name>
      <description>Implement health education class for the rural mothers in the for of one session will take about 30 minutes and it will include the following:&#xD;
  First aid (fracture, burn, bleeding, injuries and food poising). Critique malpractice for injuries management behavior at home.&#xD;
  About 10 mothers will be included in the session. Each session will take 30 minutes (in the family health center), to cover all theoretical contents.&#xD;
  The researcher will use different teaching methods as demonstration and discussion, learning aids as handout, video and pictures.</description>
      <arm_group_label>health education class</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The Mothers have normal preschool children less than 6 years regardless the child&#xD;
               gender.&#xD;
  &#xD;
            -  Educated (minimum accepted level of education is completion of primary education)&#xD;
  &#xD;
            -  Interested &amp; willing to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Mothers of children under five years</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seham Saleh, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Matrouh University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Matrouh university</name>
        <address>
          <city>Mersa Matruh</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Al-Bshri SA, Jahan S. Prevalence of home related injuries among children under 5 years old and practice of mothers toward first aid in Buraidah, Qassim. J Family Med Prim Care. 2021 Mar;10(3):1234-1240. doi: 10.4103/jfmpc.jfmpc_2265_20. Epub 2021 Apr 8.</citation>
      <PMID>34041157</PMID>
    </reference>
    <reference>
      <citation>Anwar M, Mostafa Z, Elareed H. Maternal Knowledge and Attitude about Home-related Injuries in Children under the Age of Five Years. Egyptian Family Medicine Journal (EFMJ) 2021; 5(2). 1-105. http://efmj.journals.ekb.eg/</citation>
    </reference>
    <reference>
      <citation>Bagahirwa I, Mukeshimana M, Cherian T, Nkurunziza T, El-Khatib Z, Byiringiro JC, Ng'ang'a L, Rusingiza E, Riviello R, Ndayisaba GF, Hedt-Gauthier BL. Presentation of Pediatric Unintentional Injuries at Rural Hospitals in Rwanda: A Retrospective Study. Annals of Global Health. 2020; 86(1): 116, 1-8. https://doi.org/10.5334/aogh.2711</citation>
    </reference>
    <reference>
      <citation>Centers for Disease Control and Prevention, National Center for Injury Prevention and control. Injuries Among Children and Teens.2021. https://www.cdc.gov/injury/features/child-injury/index.html#Child-Injury-Deaths-Data</citation>
    </reference>
    <reference>
      <citation>Eldosoky RS. Home-related injuries among children: knowledge, attitudes and practice about first aid among rural mothers. East Mediterr Health J. 2012 Oct;18(10):1021-7. doi: 10.26719/2012.18.10.1021.</citation>
      <PMID>23301356</PMID>
    </reference>
    <reference>
      <citation>Mohammed H, Wassif, Hakim S, Moustafa M. Frequency of Unintentional Home Injuries in Children under Five Years and its Relation with Environmental Risk Factors, Cairo, Egypt. The Egyptian Journal of Community Medicine, 2019; 37 (3). 93-102.</citation>
    </reference>
    <reference>
      <citation>Megahed M., Khalil N., Ibrahemc R., El Disoki R. Knowledge, attitude and practice of rural mothers towards home injuries among children under 5 years of age in Menoufia District- Menoufia Governorate, Egypt. Menoufia Medical Journal, 2016; 29 (4):1033-1039. DOI: 10.4103/1110-2098.202506</citation>
    </reference>
    <reference>
      <citation>Olutayo OG. Mother's Education, Age and Knowledge about Home Accident Prevention among Preschool Children in Ilesa Metropolitan City: A Relational Approach. Journal of Education and Practice, 2013; 4(11). 221-28</citation>
    </reference>
    <reference>
      <citation>Stephenson J. Caring for the injured child in set¬tings of limited resource. Semin Pediatr Surg. 2016; 25(1): 19-22. https://doi.org/10.1053/j. sempedsurg.2015.09.005</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Matrouh University</investigator_affiliation>
      <investigator_full_name>Seham El-Sayed Saleh Hassan</investigator_full_name>
      <investigator_title>Lecturer of pediatric nursing, faculty of nursing</investigator_title>
    </responsible_party>
    <keyword>Home injuries</keyword>
    <keyword>Early childhood</keyword>
    <keyword>Rural mothers</keyword>
    <keyword>First aid</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</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/NCT05984836
  org study id: IRB00013620(9/19/2025)
  nct id: NCT05984836
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Home-Related Injuries among Early Childhood: Rural Mothers' Knowledge, Attitudes and Practice
        regarding First Aid in Matrouh Governorate, Egypt
  
        Keywords: Home injuries, Early childhood, Rural mothers, First aid, Matrouh Governorate.
  Implement health education class to rural mothers about first aid measures to be taken for
        their injured children"
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Pre-postest of the knowledge, attitudes and practice (KAP) of rural mothers regarding first aid measures to be taken for injured children in Matrouh Governorate, Egypt.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Mothers' Structured Interview Schedule
  time frame: one session will take about 30 minutes
  description: This tool will be developed by the researcher after reviewing relevant literature to collect the required data from the mothers regarding first aid at home.
  Part (1): 22-item questions to assess demographic data, measuring the percentage and types of children home injuries occurred during the past 4 months.
  Part (2): 6-item questions to assess the knowledge of mothers about causes of home accidents in children. A modified part 1 and 2 structured questionnaire from (Bayomi and Mobarak, 2013; and El-Sabely et al, 2014) (6,10) was used
  Part (3): 25-item questions to assess the practice and attitude of mothers towards home-related injuries. Eight negative and 17 positive items were developed (Likert scale rate).
  Part 4: Mother's Subjective Practices regarding to first aid at home scale. This part will be developed by the researcher based on related literature (Network, 2009), (Fatouh et al., 2020), (KUMAR, SIDHU, & ZABI, 2020).
  arm group label: health education class
  arm group type: Experimental
  description: Implement health education class to rural mothers about first aid measures to be taken for injured children in Matrouh Governorate.
  intervention type: Behavioral
  intervention name: Implement health education
  description: Implement health education class for the rural mothers in the for of one session will take about 30 minutes and it will include the following:
  First aid (fracture, burn, bleeding, injuries and food poising). Critique malpractice for injuries management behavior at home.
  About 10 mothers will be included in the session. Each session will take 30 minutes (in the family health center), to cover all theoretical contents.
  The researcher will use different teaching methods as demonstration and discussion, learning aids as handout, video and pictures.
  arm group label: health education class
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Mothers of children under five years
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Seham Saleh, Lecturer
  role: Principal Investigator
  affiliation: Matrouh University
  facility: 
  country: Egypt
  citation: Al-Bshri SA, Jahan S. Prevalence of home related injuries among children under 5 years old and practice of mothers toward first aid in Buraidah, Qassim. J Family Med Prim Care. 2021 Mar;10(3):1234-1240. doi: 10.4103/jfmpc.jfmpc_2265_20. Epub 2021 Apr 8.
  PMID: 34041157
  citation: Anwar M, Mostafa Z, Elareed H. Maternal Knowledge and Attitude about Home-related Injuries in Children under the Age of Five Years. Egyptian Family Medicine Journal (EFMJ) 2021; 5(2). 1-105. http://efmj.journals.ekb.eg/
  citation: Bagahirwa I, Mukeshimana M, Cherian T, Nkurunziza T, El-Khatib Z, Byiringiro JC, Ng'ang'a L, Rusingiza E, Riviello R, Ndayisaba GF, Hedt-Gauthier BL. Presentation of Pediatric Unintentional Injuries at Rural Hospitals in Rwanda: A Retrospective Study. Annals of Global Health. 2020; 86(1): 116, 1-8. https://doi.org/10.5334/aogh.2711
  citation: Centers for Disease Control and Prevention, National Center for Injury Prevention and control. Injuries Among Children and Teens.2021. https://www.cdc.gov/injury/features/child-injury/index.html#Child-Injury-Deaths-Data
  citation: Eldosoky RS. Home-related injuries among children: knowledge, attitudes and practice about first aid among rural mothers. East Mediterr Health J. 2012 Oct;18(10):1021-7. doi: 10.26719/2012.18.10.1021.
  PMID: 23301356
  citation: Mohammed H, Wassif, Hakim S, Moustafa M. Frequency of Unintentional Home Injuries in Children under Five Years and its Relation with Environmental Risk Factors, Cairo, Egypt. The Egyptian Journal of Community Medicine, 2019; 37 (3). 93-102.
  citation: Megahed M., Khalil N., Ibrahemc R., El Disoki R. Knowledge, attitude and practice of rural mothers towards home injuries among children under 5 years of age in Menoufia District- Menoufia Governorate, Egypt. Menoufia Medical Journal, 2016; 29 (4):1033-1039. DOI: 10.4103/1110-2098.202506
  citation: Olutayo OG. Mother's Education, Age and Knowledge about Home Accident Prevention among Preschool Children in Ilesa Metropolitan City: A Relational Approach. Journal of Education and Practice, 2013; 4(11). 221-28
  citation: Stephenson J. Caring for the injured child in set¬tings of limited resource. Semin Pediatr Surg. 2016; 25(1): 19-22. https://doi.org/10.1053/j. sempedsurg.2015.09.005
  responsible party type: Principal Investigator
  investigator affiliation: Matrouh University
  investigator full name: Seham El-Sayed Saleh Hassan
  investigator title: Lecturer of pediatric nursing, faculty of nursing
  mesh term: Wounds and Injuries
  sharing ipd: No