<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/NCT02217436</url>
  </required_header>
  <id_info>
    <org_study_id>iPadWilliams</org_study_id>
    <nct_id>NCT02217436</nct_id>
  </id_info>
  <brief_title>iPad as a Distraction Tool During Facial Laceration Repair</brief_title>
  <official_title>iPad as a Distraction Tool During Facial Laceration Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency&#xD;
      department with facial lacerations requiring suture repair will be eligible to participate in&#xD;
      the study. Participating children will be randomized to standard care versus standard care&#xD;
      plus iPad use during the procedure. Children's anxiety levels assessed using a validated&#xD;
      scale will be measured from video recordings made of the procedure. Parent and provider&#xD;
      satisfaction surveys will be completed following the procedure. The primary study aim is to&#xD;
      determine how iPad use affects children's anxiety levels during facial laceration repair. The&#xD;
      secondary study aim is to determine how iPad use affects parent and provider satisfaction&#xD;
      regarding a child's facial laceration repair. Hypothesis is that iPad use decreases&#xD;
      children's anxiety levels during facial laceration repair and increases parent and provider&#xD;
      satisfaction regarding a child's facial laceration repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observational Score Behavioral Distress Revised (OSBD-R)</measure>
    <time_frame>Entire laceration repair procedure</time_frame>
    <description>Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent Survey</measure>
    <time_frame>Survey administered immediately following the laceration repair</time_frame>
    <description>Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Anxiety</condition>
  <condition>Laceration Repair</condition>
  <condition>Children</condition>
  <arm_group>
    <arm_group_label>iPad</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>iPad with age-appropriate applications, videos, and music</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPad</intervention_name>
    <description>iPad with age-appropriate applications, videos, and music</description>
    <arm_group_label>iPad</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_label>iPad</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients: Male and female children aged 2-12 of all ethnic backgrounds and&#xD;
             socioeconomic levels presenting to the emergency department for laceration repair.&#xD;
             Children sustaining single, uncomplicated facial lacerations, which can be repaired&#xD;
             with basic suture techniques, are eligible for the study. Lacerations repaired using&#xD;
             LET cream, lidocaine injection, and LET cream and lidocaine injection are all eligible&#xD;
             for the study.&#xD;
&#xD;
          2. Parents of enrolled patients.&#xD;
&#xD;
          3. Providers of enrolled patients: Residents, fellows, attendings, and nurse&#xD;
             practitioners serving as the primary provider performing the laceration repair.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients: Lacerations to parts of the body other than the face. Children with&#xD;
             developmental disabilities. Children with laceration repair requiring sedation.&#xD;
             Children with complex lacerations requiring subspecialty repair.&#xD;
&#xD;
          2. Parents and/or providers of children not eligible or enrolled in the study.&#xD;
&#xD;
          3. Providers: Medical students performing the laceration repair.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bema Bonsu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego and Rady Children's Hospital San Diego</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amy Williams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego and Rady Children's Hospital San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rady Children's Hospital San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Crellin D, Sullivan TP, Babl FE, O'Sullivan R, Hutchinson A. Analysis of the validation of existing behavioral pain and distress scales for use in the procedural setting. Paediatr Anaesth. 2007 Aug;17(8):720-33. doi: 10.1111/j.1460-9592.2007.02218.x.</citation>
    <PMID>17596217</PMID>
  </reference>
  <reference>
    <citation>Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Ann Emerg Med. 2001 Jan;37(1):20-7. doi: 10.1067/mem.2001.112003.</citation>
    <PMID>11145766</PMID>
  </reference>
  <reference>
    <citation>McQueen A, Cress C, Tothy A. Using a tablet computer during pediatric procedures: a case series and review of the &quot;apps&quot;. Pediatr Emerg Care. 2012 Jul;28(7):712-4. doi: 10.1097/PEC.0b013e31825d24eb.</citation>
    <PMID>22766593</PMID>
  </reference>
  <reference>
    <citation>Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100.</citation>
    <PMID>16585311</PMID>
  </reference>
  <reference>
    <citation>Jay SM, Elliott C. Behavioral observation scales for measuring children's distress: the effects of increased methodological rigor. J Consult Clin Psychol. 1984 Dec;52(6):1106-7. doi: 10.1037//0022-006x.52.6.1106. No abstract available.</citation>
    <PMID>6520283</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>June 28, 2018</results_first_submitted>
  <results_first_submitted_qc>July 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2019</results_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Amy Williams</investigator_full_name>
    <investigator_title>Co-Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>105 eligible patients were approached and 25 refused to participate in the study (not consented), 80 participants were randomized, and 3 withdrew from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>iPad</title>
          <description>iPad + Standard Care&#xD;
iPad: iPad with age-appropriate applications, videos, and music&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
        <group group_id="P2">
          <title>Standard Care</title>
          <description>All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Incomplete data</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>iPad</title>
          <description>iPad + Standard Care&#xD;
iPad: iPad with age-appropriate applications, videos, and music&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
        <group group_id="B2">
          <title>Standard Care</title>
          <description>Standard Care&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="39"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="77"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.0" spread="2.5"/>
                    <measurement group_id="B2" value="5.5" spread="2.6"/>
                    <measurement group_id="B3" value="5.2" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location of laceration</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Forehead/eyebrow</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lip</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Chin</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of sutures</title>
          <units>sutures</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" spread="2.4"/>
                    <measurement group_id="B2" value="4.6" spread="2.6"/>
                    <measurement group_id="B3" value="4.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of procedure</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.5" spread="6.5"/>
                    <measurement group_id="B2" value="16.4" spread="8.4"/>
                    <measurement group_id="B3" value="16.0" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Topical anesthetic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Topical</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No topical</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of restraint</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of provider</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pediatric emergency medicine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pediatrics</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Emergency medicine</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nurse practitioner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fellow</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Resident</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infiltrated anesthetic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Buffered with bicarbonate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Observational Score Behavioral Distress Revised (OSBD-R)</title>
        <description>Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse)</description>
        <time_frame>Entire laceration repair procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>iPad</title>
            <description>iPad + Standard Care&#xD;
iPad: iPad with age-appropriate applications, videos, and music&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard Care&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
          </group>
        </group_list>
        <measure>
          <title>Observational Score Behavioral Distress Revised (OSBD-R)</title>
          <description>Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse)</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0" upper_limit="6.2"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.1" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.98</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent Survey</title>
        <description>Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)</description>
        <time_frame>Survey administered immediately following the laceration repair</time_frame>
        <population>Parent own anxiety survey</population>
        <group_list>
          <group group_id="O1">
            <title>iPad</title>
            <description>iPad + Standard Care&#xD;
iPad: iPad with age-appropriate applications, videos, and music&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
            <description>Standard Care&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
          </group>
        </group_list>
        <measure>
          <title>Parent Survey</title>
          <description>Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)</description>
          <population>Parent own anxiety survey</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="3.8" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>iPad</title>
          <description>iPad + Standard Care&#xD;
iPad: iPad with age-appropriate applications, videos, and music&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
        <group group_id="E2">
          <title>Standard Care</title>
          <description>Standard Care&#xD;
Standard Care: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Amy Williams Bryl</name_or_title>
      <organization>Rady Children's Hospital San Diego</organization>
      <phone>8589668036</phone>
      <email>abryl@rchsd.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02217436
org study id: iPadWilliams
nct id: NCT02217436
lead sponsor: 
has dmc: Yes
Children aged 2-12 presenting to the Rady Children's Hospital San Diego (RCHSD) emergency
      department with facial lacerations requiring suture repair will be eligible to participate in
      the study. Participating children will be randomized to standard care versus standard care
      plus iPad use during the procedure. Children's anxiety levels assessed using a validated
      scale will be measured from video recordings made of the procedure. Parent and provider
      satisfaction surveys will be completed following the procedure. The primary study aim is to
      determine how iPad use affects children's anxiety levels during facial laceration repair. The
      secondary study aim is to determine how iPad use affects parent and provider satisfaction
      regarding a child's facial laceration repair. Hypothesis is that iPad use decreases
      children's anxiety levels during facial laceration repair and increases parent and provider
      satisfaction regarding a child's facial laceration repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Observational Score Behavioral Distress Revised (OSBD-R)
time frame: Entire laceration repair procedure
description: Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse)
measure: Parent Survey
time frame: Survey administered immediately following the laceration repair
description: Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)
arm group label: iPad
arm group type: Experimental
description: iPad with age-appropriate applications, videos, and music
arm group label: Standard Care
arm group type: Active Comparator
description: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).
intervention type: Device
intervention name: iPad
description: iPad with age-appropriate applications, videos, and music
arm group label: iPad
intervention type: Other
intervention name: Standard Care
description: All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).
arm group label: Standard Care
arm group label: iPad
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
last name: Bema Bonsu, MD
role: Principal Investigator
affiliation: University of California, San Diego and Rady Children's Hospital San Diego
last name: Amy Williams, MD
role: Principal Investigator
affiliation: University of California, San Diego and Rady Children's Hospital San Diego
facility: 
country: United States
citation: Crellin D, Sullivan TP, Babl FE, O'Sullivan R, Hutchinson A. Analysis of the validation of existing behavioral pain and distress scales for use in the procedural setting. Paediatr Anaesth. 2007 Aug;17(8):720-33. doi: 10.1111/j.1460-9592.2007.02218.x.
PMID: 17596217
citation: Luhmann JD, Kennedy RM, Porter FL, Miller JP, Jaffe DM. A randomized clinical trial of continuous-flow nitrous oxide and midazolam for sedation of young children during laceration repair. Ann Emerg Med. 2001 Jan;37(1):20-7. doi: 10.1067/mem.2001.112003.
PMID: 11145766
citation: McQueen A, Cress C, Tothy A. Using a tablet computer during pediatric procedures: a case series and review of the "apps". Pediatr Emerg Care. 2012 Jul;28(7):712-4. doi: 10.1097/PEC.0b013e31825d24eb.
PMID: 22766593
citation: Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation of nonpharmacologic methods of pain and anxiety management for laceration repair in the pediatric emergency department. Pediatrics. 2006 Apr;117(4):1162-8. doi: 10.1542/peds.2005-1100.
PMID: 16585311
citation: Jay SM, Elliott C. Behavioral observation scales for measuring children's distress: the effects of increased methodological rigor. J Consult Clin Psychol. 1984 Dec;52(6):1106-7. doi: 10.1037//0022-006x.52.6.1106. No abstract available.
PMID: 6520283
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Amy Williams
investigator title: Co-Investigator
mesh term: Lacerations
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 