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Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

Primary Purpose

Preoperative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video
Standard care
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preoperative Anxiety

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 6 and 11
  • No cerebral impairment or cognitive impairment
  • Child and his/her family native speaker of Italian
  • admission to the hospital at list one day before the sugery procedure
  • presence of written consent of the parents to the study

Exclusion Criteria:

  • age lower than 6 or upper than 11
  • presence of cerebral impairment or cognitive impairment
  • Child and his/her family are not native speaker of Italian
  • absence of written consent of the parents to the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Procedure

    Standard Care

    Arm Description

    Outcomes

    Primary Outcome Measures

    Preoperative anxiety
    Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)"

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2012
    Last Updated
    October 28, 2015
    Sponsor
    University of Florence
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01688115
    Brief Title
    Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
    Official Title
    Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Florence

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preoperative Anxiety

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Procedure
    Arm Type
    Experimental
    Arm Title
    Standard Care
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Video
    Intervention Description
    The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child
    Primary Outcome Measure Information:
    Title
    Preoperative anxiety
    Description
    Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)"
    Time Frame
    perhaps 24 hours from child admission to surgery procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 6 and 11 No cerebral impairment or cognitive impairment Child and his/her family native speaker of Italian admission to the hospital at list one day before the sugery procedure presence of written consent of the parents to the study Exclusion Criteria: age lower than 6 or upper than 11 presence of cerebral impairment or cognitive impairment Child and his/her family are not native speaker of Italian absence of written consent of the parents to the study

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27294708
    Citation
    Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.
    Results Reference
    derived

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    Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

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