Music in the Emergency Department (ED)
The Effects of a Music Intervention on Older Adults in the Emergency Department
This will be a randomized controlled study evaluating the effect of a music-listening intervention compared to standard care (control) during patient visit to the emergency department (ED). Randomization will be done with consecutive sealed envelopes.
Data collection will be prospective with administration of the State Trait Anxiety Inventory and collection of physiologic parameters (pain level, heart rate, blood pressure). Retrospective data will also be collected for covariate analysis (age, race/ethnicity, emergency severity index (ESI), pain medications administered during the ED visit, pain scores throughout ED visit, chief complaint, and ED discharge diagnosis).
調査の概要
詳細な説明
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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New York
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New York、New York、アメリカ、10032
- Columbia University Irving 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:
- Present to the ED
- Aged 65 or over
- Speak English or Spanish
Exclusion Criteria:
- Individuals who are deaf
- Prisoners
- Individuals who cannot give informed consent
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: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 |
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介入なし:Control Group
All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken.
Subjects randomized to the control group will continue the ED visit as usual.
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実験的:Music Group
All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken.
Subjects who are randomized to receive a music-listening intervention will listen to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.
An hour after enrollment, participants will be asked the same questions assessing anxiety and pain, and will also have blood pressure and heart rate taken again.
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The intervention consists of listening to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.
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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 |
|---|---|---|
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Mean Change in STAI Score
時間枠:Baseline and 1 hour post-intervention
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The STAI is scored from least/no anxiety (20 points) to severe anxiety (80 points).
The mean change in STAI scores from before the intervention to after the intervention will be calculated by subtracting the first score from second score.
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Baseline and 1 hour post-intervention
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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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Mean Change in Heart Rate (HR)
時間枠:Baseline and 1 hour post-intervention
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The HR of patients will be recorded before and immediately after the intervention (for control subjects, 1 hour after enrollment).
Difference in HR will be calculated by comparing pre to post and mean change calculated for each group.
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Baseline and 1 hour post-intervention
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Mean Change in Blood Pressure (BP)
時間枠:Baseline and 1 hour post-intervention
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The BPs of subjects will be collected before and after the intervention (for control group, 1 hour after enrollment).
Change in BP will be calculated per patient and the mean change calculated for each group.
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Baseline and 1 hour post-intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Ellen D. Sano, DO、Columbia University
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 (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
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。