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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Reunion Island
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Saint-Pierre、Reunion Island、团圆、97410
- CHU Reunion Island
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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
其他名称：
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实验性的：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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Situation anxiety measurement
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood pressure
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Malik Boukerrou, MD、Centre Hpospitalier Universitaire de La REUNION
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
手术的临床试验
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Istanbul University尚未招聘
MUSIC CARE的临床试验
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Fondation Oeuvre de la Croix Saint-Simon撤销
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Assistance Publique - Hôpitaux de Paris尚未招聘疼痛 | 疼痛，术后 | 焦虑 | 胸外科 | 疼痛，胸部 | 术后焦虑
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的