Distraction and Nitrous Oxide for Venous Puncture (DISPO)
Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial
調査の概要
詳細な説明
The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.
The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.
All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.
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
-
-
-
Geneva、スイス、1206
- Geneva Children's 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:
- Venous track needed
- French mother tongue
- Age between 3 and 9 years old
Exclusion Criteria:
- Children with cognitive disorder (autism, metabolic disorders,
- Children with cerebral-motor disability
- Children who don't speak french
- Children with ADHD treatment
- Children with epilepsy
- Children who present contraindication to the use of Nitrous oxide
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：iPad distraction
Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time. Intervention : game on iPad |
Many games will be programmed on the iPad and organized by age.
The child will choose one game and play it during all the procedure time.
|
|
アクティブコンパレータ：Nitrous Oxide
Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time. Intervention : Nitrous Oxide |
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety score
時間枠：From one hour prior to venous puncture until 1 hour afterwards
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Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards.
The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).
|
From one hour prior to venous puncture until 1 hour afterwards
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain score
時間枠：From one hour prior to venous puncture until 1 hour afterwards
|
Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).
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From one hour prior to venous puncture until 1 hour afterwards
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Satisfaction score
時間枠：From time of venous puncture until 1 hour afterwards
|
Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).
|
From time of venous puncture until 1 hour afterwards
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協力者と研究者
捜査官
- 主任研究者：Manon Cadoux, Student、University of Geneva
- 主任研究者：Virginie Luscher, Student、University of Geneva
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
- in progress (Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation)
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?
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
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