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

July 13, 2015 updated by: Ziv Hospital

The Impact of Using a Video Otoscope on Parents' Satisfaction in Pediatric Ear Examination: A Prospective Randomized Controlled Study:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video otoscopy
children under 18y admitted to the pediatric emergency room for any reason, will undergo video otoscopy
Device: DE500 Digital Video Otoscope
No Intervention: standard otoscopy
children under 18y admitted to the pediatric emergency room for any reason, undergoing routine otoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
parental satisfaction questionnaire
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 15, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZIV 0094-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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