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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02350504
• Date of registration: 24/01/2015
• Prospective Registration: No
• Primary sponsor: Soroka University Medical Center
• Public title: Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
• Scientific title: IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.
• Date of first enrolment: December 2013
• Target sample size: 131
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02350504
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Ilan Shelef, MD
• Affiliation: Soroka University Medical Center

Key inclusion & exclusion 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



Age minimum: 5 Years
Age maximum: 16 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Anxiety Level

Proportion of Anesthesia

Intervention(s)

Behavioral: Full interactive instruction

Primary Outcome(s)

Proportion of children which will be anesthetized [Time Frame: 2 years]

Secondary ID(s)

SOR033614CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors