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/NCT06012877</url>
    </required_header>
    <id_info>
      <org_study_id>UPNA-Health_Friendly</org_study_id>
      <nct_id>NCT06012877</nct_id>
    </id_info>
    <brief_title>Evaluation of the &quot;Health Friendly&quot; Program to Reduce Children's Fear of the Healthcare Environment.</brief_title>
    <acronym>HFriendly</acronym>
    <official_title>Evaluation of the &quot;Health Friendly&quot; Program to Reduce Children's Fear of the Healthcare Environment.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundacion Miguel Servet</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universidad Pública de Navarra</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fundacion Miguel Servet</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>
        The goal of this clinical trial is to evaluate the effectiveness of a novel intervention that&#xD;
        involved contact interaction with a simulated healthcare space to reduce medical fear in&#xD;
        children in infant class. The main question it aims to answer is: • Will the Health Friendly&#xD;
        Program, based on the interaction with a simulate healthcare space, reduce medica fear among&#xD;
        children in infant class? Participants will participate in the Health Friendly Program that&#xD;
        will consist of showing the children different scenarios that simulated various medical&#xD;
        contexts, letting them experiment with the material and ask questions. Researchers will&#xD;
        compare two groups (intervention group and control group) to see if there exist differences&#xD;
        between both groups in their responses to the Child Medical Fear Scale.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purpose: This study aimed to evaluate the effectiveness of a novel intervention that involved&#xD;
        contact interaction with a simulated healthcare space to reduce medical fear among children&#xD;
        in infant class.&#xD;
  &#xD;
        Methods: This was an experimental study involving 86 children divided into an intervention&#xD;
        group and a control group with pre and post measurements. The intervention, known as the&#xD;
        Health-Friendly Programme, consisted of showing children various scenarios that simulated&#xD;
        different medical contexts so that they were able to get involved in them, experiment with&#xD;
        the materials and ask questions. Medical fear was evaluated using the Spanish version of the&#xD;
        revised version of the &quot;Child Medical Fear Scale&quot;, which scored fear between 0 and 34 points.&#xD;
        The pre-test and post-test levels of medical fear in the intervention and control groups were&#xD;
        compared with the Student's t test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 15, 2019</start_date>
    <completion_date type="Actual">May 15, 2020</completion_date>
    <primary_completion_date type="Actual">April 15, 2020</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Medical fear</measure>
      <time_frame>From the participation in the intervention to one week later.</time_frame>
      <description>Medical fear was measured using the revised version of the &quot;Child Medical Fear Scale&quot; (CMFS-R), in its validated Spanish version. The scale has 17 items with statements on fear of certain aspects related to the healthcare environment, that the children answer according to a three-point scale (0 = no fear, 1 = some fear and 2 = very frightened). The maximum total score on the scale is 34 points. The Spanish validation confirmed the existence of the 4 dimensions identified in the original CMFS-R scale: intrapersonal, procedural, environmental and interpersonal fears</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">128</enrollment>
    <condition>Fear</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention, known as the Health-Friendly Programme, took place at the Clinical Skills and Simulation Centre of the Public University of Navarre. The intervention consisted of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions.&#xD;
  The structure and content of the intervention were intended to address two main issues. First, the health contexts with which school-age children may come into contact with; these are a consultation at a health centre and a hospital room. Second, the concerns, in relation to intrapersonal, procedural, environmental and interpersonal aspects, experienced by children when they interact with health care professionals or they are sick.&#xD;
  As reference material, the intervention is described in detail in the guide about the Health-Friendly Programme (Escalada-Hernández et al., 2021).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in this group continued with normal activities at school and at home, just like the intervention group, so that the only difference between the two groups was taking part in the intervention. Once the post-study data had been collected from all participants, the participant in the control group also took part in the intervention, a few days later.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Health Friendly Program</intervention_name>
      <description>The intervention, known as the Health-Friendly Programme, took place at the Clinical Skills and Simulation Centre of the Public University of Navarre. The intervention consisted of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions.&#xD;
  The structure and content of the intervention were intended to address two main issues. First, the health contexts with which school-age children may come into contact with; these are a consultation at a health centre and a hospital room. Second, the concerns, in relation to intrapersonal, procedural, environmental and interpersonal aspects, experienced by children when they interact with health care professionals or they are sick.&#xD;
  As reference material, the intervention is described in detail in the guide about the Health-Friendly Programme (Escalada-Hernández et al., 2021).</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Boys and Girls from the third year of Preschool Education (6 years old) at two schools&#xD;
               from a town in the North of Spain (school A and B) enrolled in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Leticia Martín-Rodríguez, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidad Pública de Navarra</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Public University of Navarre</name>
        <address>
          <city>Pamplona</city>
          <state>Navarra</state>
          <zip>31008</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>San Martin-Rodriguez L, Soto-Ruiz N, Ferraz-Torres M, Garcia-Vivar C, Saralegui-Gainza A, Escalada-Hernandez P. The Spanish Version of the Child Medical Fear Questionnaire: Cross-Cultural Adaptation and Validation. Int J Environ Res Public Health. 2021 Dec 31;19(1):451. doi: 10.3390/ijerph19010451.</citation>
      <PMID>35010711</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Medical Fear</keyword>
    <keyword>Children</keyword>
    <keyword>Health Education</keyword>
    <keyword>Simulated Healthcare Spaces</keyword>
    <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/NCT06012877
  org study id: UPNA-Health_Friendly
  nct id: NCT06012877
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the effectiveness of a novel intervention that
        involved contact interaction with a simulated healthcare space to reduce medical fear in
        children in infant class. The main question it aims to answer is: • Will the Health Friendly
        Program, based on the interaction with a simulate healthcare space, reduce medica fear among
        children in infant class? Participants will participate in the Health Friendly Program that
        will consist of showing the children different scenarios that simulated various medical
        contexts, letting them experiment with the material and ask questions. Researchers will
        compare two groups (intervention group and control group) to see if there exist differences
        between both groups in their responses to the Child Medical Fear Scale.
  Purpose: This study aimed to evaluate the effectiveness of a novel intervention that involved
        contact interaction with a simulated healthcare space to reduce medical fear among children
        in infant class.
  
        Methods: This was an experimental study involving 86 children divided into an intervention
        group and a control group with pre and post measurements. The intervention, known as the
        Health-Friendly Programme, consisted of showing children various scenarios that simulated
        different medical contexts so that they were able to get involved in them, experiment with
        the materials and ask questions. Medical fear was evaluated using the Spanish version of the
        revised version of the "Child Medical Fear Scale", which scored fear between 0 and 34 points.
        The pre-test and post-test levels of medical fear in the intervention and control groups were
        compared with the Student's t test.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements
  primary purpose: Other
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Medical fear
  time frame: From the participation in the intervention to one week later.
  description: Medical fear was measured using the revised version of the "Child Medical Fear Scale" (CMFS-R), in its validated Spanish version. The scale has 17 items with statements on fear of certain aspects related to the healthcare environment, that the children answer according to a three-point scale (0 = no fear, 1 = some fear and 2 = very frightened). The maximum total score on the scale is 34 points. The Spanish validation confirmed the existence of the 4 dimensions identified in the original CMFS-R scale: intrapersonal, procedural, environmental and interpersonal fears
  arm group label: Intervention Group
  arm group type: Experimental
  description: The intervention, known as the Health-Friendly Programme, took place at the Clinical Skills and Simulation Centre of the Public University of Navarre. The intervention consisted of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions.
  The structure and content of the intervention were intended to address two main issues. First, the health contexts with which school-age children may come into contact with; these are a consultation at a health centre and a hospital room. Second, the concerns, in relation to intrapersonal, procedural, environmental and interpersonal aspects, experienced by children when they interact with health care professionals or they are sick.
  As reference material, the intervention is described in detail in the guide about the Health-Friendly Programme (Escalada-Hernández et al., 2021).
  arm group label: Control group
  arm group type: No Intervention
  description: Participants in this group continued with normal activities at school and at home, just like the intervention group, so that the only difference between the two groups was taking part in the intervention. Once the post-study data had been collected from all participants, the participant in the control group also took part in the intervention, a few days later.
  intervention type: Behavioral
  intervention name: Health Friendly Program
  description: The intervention, known as the Health-Friendly Programme, took place at the Clinical Skills and Simulation Centre of the Public University of Navarre. The intervention consisted of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions.
  The structure and content of the intervention were intended to address two main issues. First, the health contexts with which school-age children may come into contact with; these are a consultation at a health centre and a hospital room. Second, the concerns, in relation to intrapersonal, procedural, environmental and interpersonal aspects, experienced by children when they interact with health care professionals or they are sick.
  As reference material, the intervention is described in detail in the guide about the Health-Friendly Programme (Escalada-Hernández et al., 2021).
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Leticia Martín-Rodríguez, PhD
  role: Principal Investigator
  affiliation: Universidad Pública de Navarra
  facility: 
  country: Spain
  citation: San Martin-Rodriguez L, Soto-Ruiz N, Ferraz-Torres M, Garcia-Vivar C, Saralegui-Gainza A, Escalada-Hernandez P. The Spanish Version of the Child Medical Fear Questionnaire: Cross-Cultural Adaptation and Validation. Int J Environ Res Public Health. 2021 Dec 31;19(1):451. doi: 10.3390/ijerph19010451.
  PMID: 35010711
  responsible party type: Sponsor
  sharing ipd: No