NCT02350504

Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Proportion of Anesthesia
• Anxiety Level

Interventions

Type	Name	Description
BEHAVIORAL	Full interactive instruction	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. In the intervention group, we use Full interactive instruction- which include an instructional booklet, a movie and a simulator's practice.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2015-01-29
• Last updated: 2015-06-19

Locations

1 site across 1 country: Israel