Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
Primary Purpose
Proportion of Anesthesia, Anxiety Level
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Full interactive instruction
Sponsored by
About this trial
This is an interventional supportive care trial for Proportion of Anesthesia
Eligibility 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
Sites / Locations
- Soroka University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Full interactive instruction
Partial instruction
Arm Description
Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice
Partial instruction which included the booklet only.
Outcomes
Primary Outcome Measures
Proportion of children which will be anesthetized
Secondary Outcome Measures
Full Information
NCT ID
NCT02350504
First Posted
January 24, 2015
Last Updated
June 18, 2015
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02350504
Brief Title
Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
Official Title
IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proportion of Anesthesia, Anxiety Level
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full interactive instruction
Arm Type
Experimental
Arm Description
Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice
Arm Title
Partial instruction
Arm Type
Placebo Comparator
Arm Description
Partial instruction which included the booklet only.
Intervention Type
Behavioral
Intervention Name(s)
Full interactive instruction
Intervention 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. In the intervention group, we use Full interactive instruction- which include an instructional booklet, a movie and a simulator's practice.
Primary Outcome Measure Information:
Title
Proportion of children which will be anesthetized
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Shelef, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer-Sheva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
7720333
Citation
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.
Results Reference
background
PubMed Identifier
10142086
Citation
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.
Results Reference
background
PubMed Identifier
22763832
Citation
Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.
Results Reference
background
PubMed Identifier
16884416
Citation
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.
Results Reference
background
PubMed Identifier
24486815
Citation
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.
Results Reference
background
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Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
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