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

Sponsor

Ziv Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02340429

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room	Device: DE500 Digital Video Otoscope	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

parental satisfaction questionnaire [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ziv Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ziv Hospital

ClinicalTrials.gov Identifier:

NCT02340429

Other Study ID Numbers:

ZIV 0094-14

First Posted:

Jan 16, 2015

Last Update Posted:

Jul 14, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of Jul 14, 2015