Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit (CessataEl'ansi)
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Julie Oncle, MD
- 电话号码：33+03 22 45 64 43
- 邮箱：Oncle.julie@chu-amiens.fr
学习地点
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Amiens、法国、80480
- CHRU Amiens
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首席研究员：
- Brassaint, MD
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首席研究员：
- Anne VANBESIEN, MD
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首席研究员：
- Sophie RIVENQ, MD
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首席研究员：
- Isabelle QUENTIN, MD
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首席研究员：
- Laurence BIRKUI, MD
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首席研究员：
- MEROT, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age > 18 years
- Patient hospitalized in palliative care unit for oncological pathology
- Presenting an anxiety score > 46 (according to the STAI-Y State scale)
- Whose subsequent hospitalization is estimated to last more than three weeks
- No deafness likely to interfere with a receptive music therapy session (no difficulty in understanding whispered speech).
- Affiliated with a social security scheme
- Have signed the consent form for the study
Exclusion Criteria:
- Deafness without hearing aids
- Patients under guardianship, curatorship or safeguard of justice
- Pregnant or breast-feeding
- Not affiliated to a social security scheme
- Patient with an aversion to the sounds produced by the Kigonki
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Group without music therapy
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- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Assessment of PANAS questionnaire, TSAI test, digital scale measurement, physiological constants (pulse, blood pressure, respiratory rate) 3 times a week for 2 weeks, then 7 days after the last of these 6 assessments.
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实验性的：Music therapy group
Tri-weekly assessments will be repeated 30 minutes after each ISM session. - Evaluation of quality of life at last assessment |
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
Assessment of PANAS questionnaire, TSAI test, digital scale measurement, physiological constants (pulse, blood pressure, respiratory rate) 3 times a week for 2 weeks, then 7 days after the last of these 6 assessments.
Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
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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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change in anxiety score obtained using the STAI-Y State scale
大体时间：1 week
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The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait |
1 week
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change in anxiety score obtained using the STAI-Y State scale
大体时间：2 weeks
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The State-Trait Anxiety Inventory (STAI), specifically Form Y (STAI-Y), stands as one of the most widely utilized self-report measures in psychological and medical research for the quantitative assessment of anxiety. The STAI-Y operationalizes the psychological construct of anxiety as having two independent dimensions, each measured by 20 items for a total of 40 items in the complete inventory. State Anxiety (A-State) is defined as a transient emotional response characterized by immediate, subjective feelings of tension, apprehension, worry, and physiological activation of the autonomic nervous system. Respondents assess their feelings "right now, at this moment" using a 4-point intensity scale. In contrast, Trait Anxiety (A-Trait) refers to stable individual differences in anxiety proneness. Individuals scoring high in A-Trait are predisposed to perceive a broader range of situations as threatening and are likely to react to these situations with elevated A-State responses. A-Trait |
2 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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PANAS questionnaire (Positive and Negative Affect Scale)
大体时间：30 minutes after the session
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30 minutes after the session
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Variations in scores of the STAI-Y ETAT scale
大体时间：30 minutes after the session
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30 minutes after the session
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pulse variation
大体时间：30 minutes after the session
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30 minutes after the session
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BP variation
大体时间：30 minutes after the session
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30 minutes after the session
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respiratory rate
大体时间：30 minutes after the session
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30 minutes after the session
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PANAS questionnaire (Positive and Negative Affect Scale)
大体时间：one week after the 6th session
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one week after the 6th session
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Variations in scores of the STAI-Y ETAT scale
大体时间：one week after the 6th session
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one week after the 6th session
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pulse variation
大体时间：one week after the 6th session
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one week after the 6th session
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BP variation
大体时间：one week after the 6th session
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one week after the 6th session
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respiratory rate
大体时间：one week after the 6th session
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one week after the 6th session
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
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