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Clinical Trials/NCT02350504
NCT02350504
Completed
Not Applicable

IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.

Soroka University Medical Center1 site in 1 country131 target enrollmentDecember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proportion of Anesthesia
Sponsor
Soroka University Medical Center
Enrollment
131
Locations
1
Primary Endpoint
Proportion of children which will be anesthetized
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

MRI has been recognized for many years as the safest and the most precise imaging method, particularly for children. However, the accuracy of MRI demands from the patient to avoid any movement while the examination is in process. This task is accomplished with difficulty by children and requires the assistance of an anesthetizing staff. In this research, our main goal is to investigate an introductory instruction as an assistive tool in performing MRI without the need in anesthesia.

Detailed Description

This is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. The children are divided randomly, each Sunday (the day there is an available anesthesia staff) we change the extent of the instruction. We use two types of instructions: 1) Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice. 2) Partial instruction which will include the booklet only. Therefore, if it is a full instruction Sunday, all the children in that day receive full instruction and vice versa, if it will is a partial instruction Sunday, all the children in that day receive partial instruction. All participants provide written informed consent after the study aims and procedures are fully explained.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilan Shelef

Department of Radiology

Soroka University Medical Center

Eligibility Criteria

Inclusion Criteria

  • All children in the age between 5 to 16 years who come ambulatory or were hospitalized to perform an MRI test, speaks Hebrew or Arabic, are capable of understanding to their age, and their parents agreed to take part in the research

Exclusion Criteria

  • Severe cerebral palsy
  • Severe ADHD
  • Children that lack of communication skills

Outcomes

Primary Outcomes

Proportion of children which will be anesthetized

Time Frame: 2 years

Study Sites (1)

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