Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial
IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beer-Sheva, 이스라엘
- Soroka University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Full interactive instruction
Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice
|
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.
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위약 비교기: Partial instruction
Partial instruction which included the booklet only.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Proportion of children which will be anesthetized
기간: 2 years
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2 years
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- Alexander M. Managing patient stress in pediatric radiology. Radiol Technol. 2012 Jul-Aug;83(6):549-60.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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