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Completed

NCT Number: NCT02350504

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

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.

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Key information

Conditions

Proportion of Anesthesia Anxiety Level

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroka University Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full interactive instruction

Behavioral

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.

Primary outcomes

  1. Proportion of children which will be anesthetized

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 29, 2015
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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