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

NCT ID: NCT02340429

Last Updated: 2015-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-04-30

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

Conditions

Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

video otoscopy

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

Group Type: EXPERIMENTAL

DE500 Digital Video Otoscope

Intervention Type: DEVICE

standard otoscopy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DE500 Digital Video Otoscope

Intervention Type: DEVICE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ZIV 0094-14

Identifier Type: -

Identifier Source: org_study_id