The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.
Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.
2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.
調査の概要
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Tel Hashomer、イスラエル、52621
- Sheba Medical Center
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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:
- age 3-12 years
- minor surgeries / diagnostic procedures such as endoscopy, biopsy
Exclusion Criteria:
- children that do not speak Hebrew
- American Society of Anesthesiologists (ASA) status above II
- a need for regional anesthesia only
- a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.
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：防止
- 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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実験的：1
Children will watch tricks ("magic") before anesthesia induction
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Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
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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 |
時間枠 |
|---|---|
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anxiety scores
時間枠：Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.
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Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome.
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postoperative maladaptive behavior rate
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二次結果の測定
結果測定 |
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preoperative anxiety scores and rate of postoperative maladaptive behavior
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ze'ev Shenkman, MD、Sheba Medical Center
研究記録日
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
Preoperative Magic Tricksの臨床試験
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University Hospital, Strasbourg, France積極的、募集していない
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The University of Texas Health Science Center,...American Heart Associationまだ募集していません
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Scitech Produtos Medicos Ltda完了
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Flanders Medical Research ProgramBiotronik SE & Co. KG完了
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Concept Medical Inc.完了アテローム性動脈硬化症 | 末梢動脈疾患シンガポール