胸部または脊椎手術後の術後疼痛に関する総合的研究
2025年6月11日 更新者：Children's Hospital Medical Center, Cincinnati
胸部または脊椎手術後の術後疼痛の遺伝的、後成的、心理社会的、および生物学的決定要因
これは、特定の遺伝子型、エピジェネティクス、行動、社会的および生物学的要因と、疼痛知覚、術後疼痛、鎮痛効果、周術期鎮痛薬の副作用、慢性術後疼痛、および遺伝子によって定義される表現型との関連を決定するための前向き研究になります。漏斗胸修復後の患者における発現。
調査の概要
詳細な説明
この研究は臨床前向き研究になります。
100 人の大胸筋と 100 人の背骨の参加者 (各腕で 50/50 に無作為化) に限定される瞑想介入に関するものを除いて、すべての目的は観察的です。
研究期間中に 600 人の適格な参加者を募集し、表現型と遺伝子型を一致させる予測モデルを導き出すために必要なデータを取得します。
この研究は、留置ラインからの採血と、無作為化された瞑想グループのための追加の統合的健康手順（集中的注意瞑想ガイダンス、および定期的なマッサージと呼吸法）の使用を除いて、標準的な麻酔または周術期ケアを妨げません。 .
研究スタッフは、心理社会的および体性感覚の評価を管理し、参加者の医療記録から関連データを記録します。
インテグレーテッドヘルスは、術前段階で無作為化された瞑想参加者に集中的注意瞑想を教えるのに役立ちます。
すべての参加者にアクティグラフィー装置が提供され、無作為化された瞑想グループの参加者には MUSETM が提供されます。
疼痛チームは、Pectus Pain Management Protocol に従って、周術期の疼痛管理を指揮します。
研究の種類
介入
入学 (推定)
600
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Cincinnati Childrens Hospital Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 8歳から成人までのお子様
- 漏斗胸または思春期特発性脊柱側弯症の診断
- 内視鏡的漏斗胸修復または脊椎固定の予定
除外基準:
- 腎疾患または肝疾患の病歴または活動性
- 過去 5 年間にオピオイドを必要とする大手術
- 重度の呼吸器系の問題（閉塞性睡眠時無呼吸、嚢胞性線維症、肺線維症、または先月以内の肺炎など）
- チアノーゼ性心疾患、低形成性左心室、不整脈、治療中の高血圧症、川崎病、または心筋症を含むがこれらに限定されない心臓病。 無症候性の弁病変または欠陥のある参加者が含まれる場合があります
- -現在薬で治療されている発作の病歴（薬を服用せず、1年以上発作がない参加者が含まれる場合があります）
- パロキセチン、フルオキセチン、シメチジン、デュロキセチンなど、CYP2D6活性を誘導または阻害することが知られている併用薬を2つ以上服用していない
- 術後換気または術中心臓バイパス待機が必要
- BMI >35
- 妊娠中または授乳中の女性
- 非英語圏
- 明確な発達遅滞
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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：コントロール
対照群の参加者は、現在の標準的なケアを受けます。これには、手術後の統合ケアによる参加者/家族のニーズの評価、および認可/認定されたホリスティックヘルススペシャリストによる標準的なホリスティックヘルスケアが含まれます。
MUSETM 集中注意瞑想トレーニングや介入プロトコルは受けません。
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実験的：瞑想
注意集中瞑想トレーニングを受けるために無作為化された参加者は、認可/認定されたホリスティックヘルススペシャリストが提供する術前トレーニングセッションに参加します。
コンテンツには、呼吸に焦点を当てた注意集中瞑想の年齢に応じた説明が含まれます。 MUSETM ヘッドバンドのセットアップと使用。そして体験練習。
介入の目標は、マインドフルネス（つまり、感覚、感情、思考に対する瞬間的な判断や反応のない認識）を高め、自己調整戦略を提供し、ストレスに対する健康的で適応的な反応を促進することです。
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瞑想介入に割り当てられた参加者は、術前に集中注意瞑想トレーニングを受け、手術前に 1 日 20 分間瞑想するように勧められます。
術後の入院期間中、参加者は、標準的なホリスティック ヘルスケア、瞑想トレーニングの強化、および呼吸に焦点を合わせたガイド付き集中注意瞑想を少なくとも 20 分間練習するよう奨励されます。入院中は毎日。
患者は、退院後も MUSETM ニューロフィードバック支援瞑想を継続して使用するよう求められ、痛みのテストを繰り返すために来院し、その時点で MUSETM ヘッドバンドを返却します。
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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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痛みスコアの軌跡
時間枠：1年
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疼痛スコアは、術前から術後 1 年まで収集されます。
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1年
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自己申告による心理社会的スコアの変化 (不安、痛み、対処、身体的制限などを含む)
時間枠：1年
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心理社会的対策は、術前から術後1年まで収集されます
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1年
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心拍変動の変化
時間枠：8週間
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心拍変動は、術前および術後に評価されます
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8週間
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グループ（介入/介入なし）および時間（手術前/手術後）ごとの、アルファ周波数帯域の下限、上限、および全体の平均振幅値の変化
時間枠：8週間
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脳活動は、術前および術後に評価されます
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8週間
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瞑想中および実験的疼痛課題中の誘発反応電位 (ERP) の変化
時間枠：8週間
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脳活動は、術前および術後に評価されます
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8週間
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睡眠効率/持続時間の変化 (アクチグラフィー) および自己申告による睡眠の質
時間枠：8週間
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睡眠の効率と質は術前と術後に評価されます
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8週間
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副作用対策の発生率
時間枠：術後72時間
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呼吸抑制、鎮静、術後の吐き気および嘔吐の発生率は、回復段階で収集されます
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術後72時間
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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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圧痛閾値、条件付けられた痛みの変調、触覚弁別、および時間的総和指数の変化
時間枠：8週間
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定量的官能検査は、術前および術後に評価されます
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8週間
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Vidya Chidambaran, MD、Children's Hospital Medical Center, Cincinnati
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年7月6日
一次修了 (推定)
2025年12月31日
研究の完了 (推定)
2025年12月31日
試験登録日
最初に提出
2018年9月20日
QC基準を満たした最初の提出物
2019年7月23日
最初の投稿 (実際)
2019年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2025年6月13日
QC基準を満たした最後の更新が送信されました
2025年6月11日
最終確認日
2025年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2017-5817
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?
はい
IPD プランの説明
匿名化されたデータは、追加の内部または外部のデータ ウェアハウス/調査者と共有される場合があります。
これらには、CCHMC (IRB 2008-0834) の i2b2-Research Data Warehouse プロトコルが含まれますが、i2b2 データベースを介して参加者の電子医療記録の匿名化されたコピーにこのデータをリンクすることを目的としています。
結果として得られる匿名化された i2b2 データベースは、この研究の一部ではなく、将来の調査研究および NIH-db-GaP (遺伝子型および表現型のデータベース) で二次表現型を調査するために使用されます。
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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