Visual Information Booklet and Anxiety in Preschool Children Undergoing Sedated MRI
The Effect of a Visual Information Booklet on Preprocedural Anxiety in Preschool Children Undergoing Magnetic Resonance Imaging Under Sedation: A Prospective Randomized Controlled Trial
This study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet called "MR Maceram" ("My MRI Adventure"). Families received the booklet at the anesthesia outpatient clinic before the scan day.
On the MRI day, children's anxiety was assessed in the waiting area and again in the preparation area before intravenous cannulation and sedative medication. Parents completed an anxiety questionnaire, and children's cooperation during intravenous cannulation was recorded. The main comparison was children's anxiety in the preparation area. The study was conducted at Kocaeli University Faculty of Medicine Hospital in Türkiye and is being registered after completion.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kocaeli
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İzmit, Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University Faculty of Medicine Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children aged 3 to 6 years scheduled to undergo MRI under sedation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent.
Exclusion Criteria:
- Use of sedative or anxiolytic medication before the procedure.
- Emergency MRI.
- Acute pain, marked agitation, clinical instability, or communication or cooperation difficulties severe enough to prevent reliable assessment using the study scales.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Standard Verbal Information
Children and their families received routine verbal information about the MRI and sedation process at the anesthesia outpatient clinic. They did not receive the illustrated booklet. |
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실험적: MR Maceram Booklet and Standard Verbal Information
Children and their families received routine verbal information plus the illustrated "MR Maceram" booklet at the anesthesia outpatient clinic before the MRI day. Families could review the booklet with their child before the scan. |
An age-appropriate illustrated booklet explaining hospital arrival, waiting, intravenous cannulation, sedation, the MRI scan, and recovery. It was given at the anesthesia outpatient clinic before the MRI day in addition to routine verbal information. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Child Anxiety Before IV Cannulation (mYPAS-T2)
기간: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Child Anxiety in the MRI Waiting Area (mYPAS-T1)
기간: Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
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Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
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Parental State Anxiety (STAI-S)
기간: Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
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Parental state anxiety was assessed using the State-Trait Anxiety Inventory, State subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
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Child Cooperation During IV Cannulation
기간: Periprocedural (MRI day), during IV cannulation before sedative administration.
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Cooperation was assessed using a three-category observational scale: 0, good cooperation; 1, partial resistance; and 2, marked resistance. |
Periprocedural (MRI day), during IV cannulation before sedative administration.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Murat Tekin, MD, Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GOKAEK-2026/07/38
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data will not be shared with other researchers. The informed consent specified that study data would be accessible only to the research team.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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