A Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
A Randomized Clinical Trial of a Psycho-educational Intervention to Improve Pain Management After Day Surgery
Evidence indicates that postoperative pain after day surgery is inadequately controlled. Patients have different experiences and knowledge about how to deal with pain, and the need for information and clarification may vary. The aim of this study is to enhance pain management by academic detailing (patients' current knowledge and motivations are the basis for information) and nurse coaching (frequent and individualized support). The study consists of 4 phases; (1) a pilot study about patients experience with pain after surgery by a structured telephone interview; (2) development of an intervention to improve pain management; (3) implement and evaluate the intervention; (4) evaluate the incidence of chronic pain after day surgery. Even if patients are prescribed sufficient doses of analgesics, pain relief is dependent on patients' adherence with the analgesic regimen. Psychological factors, such as catastrophizing may also contribute to patients' experience of postoperative pain. Strategies that may be more effective than general information concerning surgery and pain management is academic detailing and nurse coaching, and will be used as frame for the intervention.
Hypothesis:
Over the seven days after surgery patients in the intervention group report;
- higher adherence with the analgesic regimen,
- have less pain intensity and pain interference with function and
- lower severity of side effects compared to the control group.
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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Oslo、ノルウェー、N-0130
- Oslo and Akershus University College of Apllied Sciences
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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:
- > 18 years of age;
- able, to read, write, and understand Norwegian;
- are scheduled for orthopedic (shoulder, bunnies), or breast reconstruction surgery and
- have a telephone line.
Exclusion Criteria:
- Staying overnight in hospital
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：コントロール
標準ケア
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実験的：counselling
Patients who receive the Pain booklet and support by telephone
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Patients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management
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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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Average pain intensity
時間枠：1 week
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Brief Pain Inventory
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1 week
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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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The relationships between pain sensitivity, catastrophizing, perceived barriers to pain management and adherence to analgesics and pain intensity.
時間枠：1,2,3,7 day after surgery
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1,2,3,7 day after surgery
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Pain occurence
時間枠：3 and 6 month after surgery
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Brief Pain Inventory
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3 and 6 month after surgery
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協力者と研究者
捜査官
- 主任研究者：Berit Valeberg, PhD、Oslo Metropolitan University
出版物と役立つリンク
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。
慢性の痛みの臨床試験
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