Evaluation of the Effectiveness of Music Therapy on Anxiety Levels in Patients With Advanced Cancer Hospitalized in a Palliative Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- change in anxiety score obtained using the STAI-Y State scale
研究概览
简要总结
A music therapy intervention can be either receptive or active. In both cases, somatic effects have been observed, with a direct impact on respiratory, cardiac and hemodynamic parameters, as well as psychological effects, creating a relationship of support, accompaniment and listening to the person. An intervention protocol using Kigonki has been developed and validated by the University Diploma in Music Therapy team at Paul-Valéry Montpellier 3 University (DUMM3). Studies on music therapy in palliative care have been published, but there is still a need for large controlled studies assessing the prolonged effect of a standardized intervention. This randomized clinical is designed for patients with terminal cancer pathology, hospitalized in palliative care units and with anxiety and depression scores both above 11 on the Hospital Anxiety and Depression scale (HAD). The primary endpoint is change in anxiety score. Patients included in the experimental arm will be offered the above-mentioned protocol with 3 weekly sessions of receptive music therapy with Kigonki for 2 weeks, after drawing up an intervention plan. Anxiety/depression levels will be measured before and 30 minutes after each session, as well as one week after the last session. Patients in the reference arm will have their anxiety/depression level monitored 3 times a week. In both arms, the study will be terminated at the end of the last protocol evaluation (i.e., at 3 weeks). If anxiety worsens (score rises by 2 points), a music therapy intervention similar to that performed for patients of the experimental arm may be proposed to patients of the reference arm. This project requires the participation of 84 patients, which seems feasible at the inter-regional level in 7 centers over 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group without music therapy
- 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.
- Evaluation of quality of life at last assessment
干预措施: depression management (Other)
Group without music therapy
- 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.
- Evaluation of quality of life at last assessment
干预措施: questionnaire (Other)
Music therapy group
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
- Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
- Assessment of the 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.
Tri-weekly assessments will be repeated 30 minutes after each ISM session.
- Evaluation of quality of life at last assessment
干预措施: depression management (Other)
Music therapy group
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
- Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
- Assessment of the 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.
Tri-weekly assessments will be repeated 30 minutes after each ISM session.
- Evaluation of quality of life at last assessment
干预措施: Kigonki (Other)
Music therapy group
- Management of anxiety, pain, and depression according to the usual pharmacological and non-pharmacological practices of each center.
- Six 30-minute sessions of receptive ISM with Kigonki according to study protocol
- Assessment of the 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.
Tri-weekly assessments will be repeated 30 minutes after each ISM session.
- Evaluation of quality of life at last assessment
干预措施: questionnaire (Other)
结局指标
主要结局
change in anxiety score obtained using the STAI-Y State scale
时间窗: 1 week
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
change in anxiety score obtained using the STAI-Y State scale
时间窗: 2 weeks
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
次要结局
- PANAS questionnaire (Positive and Negative Affect Scale)(30 minutes after the session)
- Variations in scores of the STAI-Y ETAT scale(30 minutes after the session)
- pulse variation(30 minutes after the session)
- BP variation(30 minutes after the session)
- respiratory rate(30 minutes after the session)
- PANAS questionnaire (Positive and Negative Affect Scale)(one week after the 6th session)
- Variations in scores of the STAI-Y ETAT scale(one week after the 6th session)
- pulse variation(one week after the 6th session)
- BP variation(one week after the 6th session)
- respiratory rate(one week after the 6th session)