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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kocaeli
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İzmit、Kocaeli、トルコ（Türkiye）、41380
- Kocaeli University Faculty of Medicine Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Child Anxiety Before IV Cannulation (mYPAS-T2)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Child Anxiety in the MRI Waiting Area (mYPAS-T1)
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Murat Tekin, MD、Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- GOKAEK-2026/07/38
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。