Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-03-06 @ 1:27 AM
Study NCT ID:
NCT02350504
Status:
COMPLETED
Last Update Posted:
2015-06-19
First Post:
2015-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-18', 'studyFirstSubmitDate': '2015-01-24', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2015-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of children which will be anesthetized', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Proportion of Anesthesia', 'Anxiety Level']}, 'referencesModule': {'references': [{'pmid': '7720333', 'type': 'BACKGROUND', '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.'}, {'pmid': '10142086', 'type': 'BACKGROUND', '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."}, {'pmid': '22763832', 'type': 'BACKGROUND', 'citation': 'Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.'}, {'pmid': '16884416', 'type': 'BACKGROUND', '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.'}, {'pmid': '24486815', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nTherefore, 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.\n\nAll participants provide written informed consent after the study aims and procedures are fully explained."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Severe cerebral palsy\n* Severe ADHD\n* Children that lack of communication skills'}, 'identificationModule': {'nctId': 'NCT02350504', 'briefTitle': 'Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.', 'orgStudyIdInfo': {'id': 'SOR033614CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full interactive instruction', 'description': "Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice", 'interventionNames': ['Behavioral: Full interactive instruction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Partial instruction', 'description': 'Partial instruction which included the booklet only.'}], 'interventions': [{'name': 'Full interactive instruction', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['Full interactive instruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Ilan Shelef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soroka University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Radiology', 'investigatorFullName': 'Ilan Shelef', 'investigatorAffiliation': 'Soroka University Medical Center'}}}}