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

Soroka University Medical Center

Status: Completed

Conditions: Anxiety Level; Proportion of Anesthesia

Treatments: Behavioral: Full interactive instruction

Study type: Interventional

Funder types: Other

Identifiers

NCT02350504

SOR033614CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups, including a placebo group

Full interactive instruction

Experimental group

Description:

Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice

Treatment:

Behavioral: Full interactive instruction

Partial instruction

Placebo Comparator group

Description:

Partial instruction which included the booklet only.