Painful Procedures in the Emergency Department: A Distraction Intervention (3-5 Year Olds) (ERPain)
Painful Procedures in the Emergency Department: Does a Formal Program in Distracting Techniques for Parents and Children Reduce Pain and Anxiety in Children (3-5 Year Olds)?
調査の概要
詳細な説明
The purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. An instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure, to teach coping skills that can be used before and during the painful procedure, and to provide distraction during the procedure by using an entertaining video segment.
Approximately 168 children (3-5 years of age) who are seen in the IWK ED requiring venipunctures for blood collection or IV starts will be randomized. Parent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable DVD player. Fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the IWK ED. Those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. It is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Nova Scotia
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Halifax、Nova Scotia、カナダ、B3K 6R8
- IWK Health Centre
-
-
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:
Participants will be eligible for this study if they:
- Are between 3-5 years of age
- Are presenting in the IWK Emergency Department requiring venipuncture for blood collection or intravenous (IV) initiation.
- Are able to read and speak English
- Provide written parental authorization
Exclusion Criteria:
Participants will be excluded for this study if they:
- Are in critical condition as determined by ED staff
- Are in significant pain for other reasons other than the venipuncture
- Have severe cognitive delay
- Require sedation for the venipuncture as determined by the ED staff
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:Treatment
50% randomized to receive distraction intervention during painful procedure
|
Cognitive-Behavioral/Relaxation Intervention
|
介入なし:Control
50% RANDOMIZED TO RECEIVE NO INTERVENITON
|
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 |
---|---|
処置中にビデオ録画された視覚的疼痛反応の CAMPIS コーディング
時間枠:継続的な
|
継続的な
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
子どもの不安の評価
時間枠:事後手続き
|
事後手続き
|
CHEOPS分析
時間枠:事後手続き
|
事後手続き
|
Parental reports of: Child pain ratings (Faces Pain Scale Revised)
時間枠:post-procedure
|
post-procedure
|
協力者と研究者
研究記録日
主要日程の研究
研究開始
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 (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
本研究に関する用語
その他の研究ID番号
- 3416
- Mayday grant
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。
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