NCT02350504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

January 24, 2015

Last Update Submit

June 18, 2015

Conditions

Proportion of AnesthesiaAnxiety Level

Outcome Measures

Primary Outcomes (1)

  • Proportion of children which will be anesthetized

    2 years

Study Arms (2)

Full interactive instruction

EXPERIMENTAL

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

Behavioral: Full interactive instruction

Partial instruction

PLACEBO COMPARATOR

Partial instruction which included the booklet only.

Interventions

Full interactive instructionBEHAVIORAL

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.

Full interactive instruction

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related Publications (5)

  • Marshall SP, Smith MS, Weinberger E. Perceived anxiety of pediatric patients to magnetic resonance. Clin Pediatr (Phila). 1995 Jan;34(1):59-60. doi: 10.1177/000992289503400114. No abstract available.

    PMID: 7720333BACKGROUND

  • Tyc VL, Fairclough D, Fletcher B, Leigh L, Mulhern RK. Children's distress during magnetic resonance imaging procedures. Child Health Care. 1995 Winter;24(1):5-19. doi: 10.1207/s15326888chc2401_2.

    PMID: 10142086BACKGROUND

  • Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.

    PMID: 22763832BACKGROUND

  • de Amorim e Silva CJ, Mackenzie A, Hallowell LM, Stewart SE, Ditchfield MR. Practice MRI: reducing the need for sedation and general anaesthesia in children undergoing MRI. Australas Radiol. 2006 Aug;50(4):319-23. doi: 10.1111/j.1440-1673.2006.01590.x.

    PMID: 16884416BACKGROUND

  • Tornqvist E, Mansson A, Hallstrom I. Children having magnetic resonance imaging: A preparatory storybook and audio/visual media are preferable to anesthesia or deep sedation. J Child Health Care. 2015 Sep;19(3):359-69. doi: 10.1177/1367493513518374. Epub 2014 Jan 31.

    PMID: 24486815BACKGROUND

Study Officials

  • Ilan Shelef, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Radiology

Study Record Dates

First Submitted

January 24, 2015

First Posted

January 29, 2015

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 19, 2015

Record last verified: 2015-06

Locations

IL(1)