Efficiency of Favourite Versus Predetermined Musical Sequence on Gynecology Pre-operative Anxiety (MUANX)
Comparison of Musicotherapy Sessions Using Patient Play-list Versus U Sequence Music Care Medical Device on Pre-operative Anxiety in Women Undergoing Gynecological Surgery: a Randomized-control Study
Anxiety is a psychologic and physiological state that could be characterized by somatic, emotional, cognitive and behavioral components. Surgery, as well as waiting for surgery is an anxiogenic situation encountered by 60 à 80 % of the patients. High levels of anxiety lead to negative physiological signs that slow down healing, lowers imune response and increases post-surgery infection. Anxiety also increases pain and post-surgery morbi-mortality. Drug-induced sedation is frequently recommended to lower anxiety. The anxiolytic effect of alternative treatment such as musicotherapy has been demonstrated in several randomized control trials. Nevertheless, most of these studies have investigated the effect of musicotherapy in groups with our without musical listening.
In the present study, investigators assume that a personal musical sequence composed by favourite songs of the patients could have beneficial effect on presurgical anxiety than selective sequence of the medical device MUSIC CARE.
In this study, the anxiolytic effect of predefined U musical sequences that alternate slow and faster music tracks (medical device MUSIC CARE) are compared to patient's play-list, in women with planned gynecological surgery.
調査の概要
詳細な説明
Patients are randomly allocated in two groups:
- control group: patients are asked to choose one of the U sequence among the preselected music style proposed by the medical device MUSIC CARE
- test group: patients are asked to prepare their own play-list containing their favourite songs
Anxiety is assessed before and after a 20 min-musicotherapy session by using the State-Trait Anxiety Inventory (STAI) for anxiogenic situation.
Other parameters are measured such as blood pressure, cardiac frequency, level of pain after surgery, care stay duration, potent post-surgery complications.
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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Reunion Island
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Saint-Pierre、Reunion Island、再会、97410
- CHU Reunion Island
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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:
- with planed gynecologic surgery
- without anxiolytic medication
- able to prepare their own play-list
- signed inform consent
Exclusion Criteria:
- hearing disorder
- dementia or psychiatric disorder
- neurologic disorder
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：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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アクティブコンパレータ：MUSIC CARE
Listening for 20 min of one of the music style U sequences proposed by the medical device MUSIC CARE
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Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
他の名前：
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実験的：PERSONAL PLAY-LIST
Listening for 20 min of patient's play-list
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Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
他の名前：
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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 |
|---|---|---|
|
Situation anxiety measurement
時間枠：Change from baseline anxiety at 20 minutes musical listening
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Pre-operative anxiety is assessed by the STAY-situation questionnaire
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Change from baseline anxiety at 20 minutes musical listening
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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 |
|---|---|---|
|
Blood pressure
時間枠：Change from baseline blood pressure at 20 minutes musical listening
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Measurement of blood pressure
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Change from baseline blood pressure at 20 minutes musical listening
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Post-operative pain
時間枠：Up to one hour after surgery recovery
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Pain is assessed after surgery recovery using Visual Analogic Scale
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Up to one hour after surgery recovery
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Care stay duration
時間枠：At study completion, an average of 3 days
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Hospital stay is assessed by the number of days
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At study completion, an average of 3 days
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Post-operative complications
時間枠：Through study completion, an average of 3 days
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All post-operative complications are recorded
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Through study completion, an average of 3 days
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Heart rate
時間枠：Change from baseline heart at 20 minutes musical listening
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Measurement of heart rate
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Change from baseline heart at 20 minutes musical listening
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協力者と研究者
捜査官
- 主任研究者：Malik Boukerrou, MD、Centre Hpospitalier Universitaire de La REUNION
出版物と役立つリンク
一般刊行物
- Reynaud D, Bouscaren N, Lenclume V, Boukerrou M. Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial. Trials. 2021 Aug 13;22(1):535. doi: 10.1186/s13063-021-05511-2.
- Petot T, Bouscaren N, Maillard O, Huiart L, Boukerrou M, Reynaud D. Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial. Trials. 2019 Jan 7;20(1):20. doi: 10.1186/s13063-018-3093-6.
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
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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