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

About this trial
This is an interventional health services research trial for Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room
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.
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
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:
We'll reach out to this number within 24 hrs