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Using a Video Otoscope in Pediatric Ear Examination: A Prospective Randomized Controlled Study:

Primary Purpose

Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DE500 Digital Video Otoscope
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children under 18y admitted to the pediatric ER for any reason, undergoing routine otoscopy, who's parents have signed an informed consent.

Exclusion Criteria:

  • no parental informed consent, lack of compliance or inability to perform otoscopy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    video otoscopy

    standard otoscopy

    Arm Description

    children under 18y admitted to the pediatric emergency room for any reason, will undergo video otoscopy

    children under 18y admitted to the pediatric emergency room for any reason, undergoing routine otoscopy

    Outcomes

    Primary Outcome Measures

    parental satisfaction questionnaire

    Secondary Outcome Measures

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    July 13, 2015
    Sponsor
    Ziv Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02340429
    Brief Title
    Using a Video Otoscope in Pediatric Ear Examination: A Prospective Randomized Controlled Study:
    Official Title
    The Impact of Using a Video Otoscope on Parents' Satisfaction in Pediatric Ear Examination: A Prospective Randomized Controlled Study:
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ziv Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Medical care today is moving towards patient centered care (PC) and patient empowerment (PE), both in practice and in medical staff training . Applying this methodology enhances patient autonomy in the clinical setting and allows shared decision making. Current mobile and video technology enables the caregiver(clinician) to share visual data with the patient, making him or her a more active participant in the medical procedure. It has been shown that higher patient satisfaction rate regarding the patient/physician encounter, has a positive effect on medical procedure outcome and patient compliance. Patient centered care and Patient Empowerment benefits are maximized using the proper tools. One such tool is the video otoscope. In this study we apply the PC/PE approach of medical care and introduce video otoscopy in the setting of a pediatric emergency room. We use an affordable (~300$), FDA approved, High Res. video otoscope. (DE500 Digital Video Otoscope,Firefly global Inc.) Patients will be randomized upon admission into two groups: video otoscopy and standard otoscopy. Upon discharge from the pediatric ER, parents will be asked to answer a short questionnaire regarding their satisfaction with the ER visit and the otoscopic examination. We aim to study the impact of affordable, high res. video otoscopy, on the general satisfaction of parents from their emergency room experience, vs their experience when undergoing a regular otoscopic examination. Inclusion criteria: children under 18y admitted to the pediatric ER for any reason, undergoing routine otoscopy, who's parents have signed an informed consent. Exclusion criteria: no parental informed consent,lake of compliance or inability to perform otoscopy. Number of participants: 60 (30 in each group) Study start: January 2015 Study ends:January 2016 Study location: Ziv medical center, Zefat Israel

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    video otoscopy
    Arm Type
    Experimental
    Arm Description
    children under 18y admitted to the pediatric emergency room for any reason, will undergo video otoscopy
    Arm Title
    standard otoscopy
    Arm Type
    No Intervention
    Arm Description
    children under 18y admitted to the pediatric emergency room for any reason, undergoing routine otoscopy
    Intervention Type
    Device
    Intervention Name(s)
    DE500 Digital Video Otoscope
    Primary Outcome Measure Information:
    Title
    parental satisfaction questionnaire
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children under 18y admitted to the pediatric ER for any reason, undergoing routine otoscopy, who's parents have signed an informed consent. Exclusion Criteria: no parental informed consent, lack of compliance or inability to perform otoscopy.

    12. IPD Sharing Statement

    Learn more about this trial

    Using a Video Otoscope in Pediatric Ear Examination: A Prospective Randomized Controlled Study:

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