<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/NCT03763292</url>
  </required_header>
  <id_info>
    <org_study_id>REK2018/1830</org_study_id>
    <nct_id>NCT03763292</nct_id>
  </id_info>
  <brief_title>Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery</brief_title>
  <official_title>Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Helse Nord-Trøndelag HF</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      Children who will have surgery and need anesthesia, and their parents are often anxious and&#xD;
      show signs of stress and discomfort. A main reason for concern and anxiety is fear of&#xD;
      anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the&#xD;
      study is to see if a specific preoperative information brochure aimed at the parents will&#xD;
      make the parents feel better prepared for the procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">July 3, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Satisfaction with information</measure>
    <time_frame>10 minutes</time_frame>
    <description>Self-reported satisfaction with provided information on a 5 point Likert scale where 1 is less satisfied and 5 is high satisfaction (range 1-5). In total four questions (sum score range 4-20)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preparedness for the operating room setting</measure>
    <time_frame>10 minutes</time_frame>
    <description>Self-reported to what degree parents feel prepared as to what will happen before/during induction of anaesthesia on a 5 point Likert scale where 1 is less prepared and 5 is very well prepared (range 1-5). In total two questions (sum score range 2-10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Score (PSS-14)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Self-reported perceived stress measured by 14 questions on a 5-point Likert scale where 1 is Never and 5 is very often. Range for the total score is 1-70.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Anxiety</condition>
  <condition>Consumer Satisfaction</condition>
  <arm_group>
    <arm_group_label>Information brochure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: The parents are given a specific information brochure that describes the procedures that the child is going through during anesthesia when it has been decided that the child is going to have the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Information as usual, i.e. oral information about the procedures to parents when they arrive at the hospital with the child that is going to have the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Specific information brochure</intervention_name>
    <description>A purpose-designed brochure about anesthesia and surgery in the ear in children is developed by the investigators. This brochure has photos and describes the procedures the child is going through.</description>
    <arm_group_label>Information brochure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents with children undergoing ear-nose-throat surgery in the study period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents who do not speak nor read Norwegian.&#xD;
&#xD;
          -  Parents who do not want to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siri Forsmo, phd prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University for Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sykehus Levanger</name>
      <address>
        <city>Levanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parents</keyword>
  <keyword>Patient Education as Topic</keyword>
  <keyword>Preoperative Care</keyword>
  <keyword>Pamphlets</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymous participant data plotted in a SPSS file can be shared on request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>September 2019 - August 2024 (5 years)</ipd_time_frame>
    <ipd_access_criteria>Request to contact persons.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03763292
org study id: REK2018/1830
nct id: NCT03763292
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children who will have surgery and need anesthesia, and their parents are often anxious and
      show signs of stress and discomfort. A main reason for concern and anxiety is fear of
      anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the
      study is to see if a specific preoperative information brochure aimed at the parents will
      make the parents feel better prepared for the procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Satisfaction with information
time frame: 10 minutes
description: Self-reported satisfaction with provided information on a 5 point Likert scale where 1 is less satisfied and 5 is high satisfaction (range 1-5). In total four questions (sum score range 4-20)
measure: Preparedness for the operating room setting
time frame: 10 minutes
description: Self-reported to what degree parents feel prepared as to what will happen before/during induction of anaesthesia on a 5 point Likert scale where 1 is less prepared and 5 is very well prepared (range 1-5). In total two questions (sum score range 2-10)
measure: Perceived Stress Score (PSS-14)
time frame: 10 minutes
description: Self-reported perceived stress measured by 14 questions on a 5-point Likert scale where 1 is Never and 5 is very often. Range for the total score is 1-70.
arm group label: Information brochure
arm group type: Experimental
description: Intervention: The parents are given a specific information brochure that describes the procedures that the child is going through during anesthesia when it has been decided that the child is going to have the surgery.
arm group label: Information as usual
arm group type: No Intervention
description: Information as usual, i.e. oral information about the procedures to parents when they arrive at the hospital with the child that is going to have the surgery.
intervention type: Behavioral
intervention name: Specific information brochure
description: A purpose-designed brochure about anesthesia and surgery in the ear in children is developed by the investigators. This brochure has photos and describes the procedures the child is going through.
arm group label: Information brochure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Siri Forsmo, phd prof
role: Study Director
affiliation: Norwegian University for Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Anonymous participant data plotted in a SPSS file can be shared on request.
ipd info type: Study Protocol
ipd time frame: September 2019 - August 2024 (5 years)
ipd access criteria: Request to contact persons.