Meraki: Music Therapy Protocol for People With Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in emotional distress (T1, T2, T3 and T4)
研究概览
简要总结
The overall aim of the study is to analyse the impact of a music therapy-based treatment on the emotional well-being and quality of life of cancer patients in palliative care (PC). To this end, the effectiveness and efficiency of a music therapy-based treatment to improve adaptation to illness and psychological well-being in this population will be validated and implemented.
Specifically, the implementation of an individualised treatment programme for palliative care patients will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •The patient is receiving palliative care for an oncological diagnosis and was admitted to the hospital a week ago. They do not have moderate to severe cognitive impairment. This treatment is for oncological patients in an advanced stage who are receiving palliative anti-tumour treatment such as chemotherapy and/or radiotherapy. These patients require support treatment that cannot be provided at home due to their complexity. The patient is in an advanced or terminal phase of the disease according to WHO criteria.
- •Be over 18 years of age.
- •Have preserved cognitive ability (SPMSQ, Pfeiffer). More than 2 errors (3 in illiterate persons) would suggest the presence of cognitive impairment.
- •Have signed the informed consent form
- •Have completed at least 2 of the 3 treatment sessions and have completed the pre-test and post-test assessment.
排除标准
- •Estimated survival time. Patients with a life expectancy of two weeks or less shall not be operated on.
研究组 & 干预措施
Control Group
Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).
Experimental group
The study will commence with an initial evaluation (T1) one week after the patients' admission to the hospital. After an equal amount of time has passed without receiving any treatment, patients will undergo a re-evaluation (T2). Subsequently, patients will receive the music therapy treatment protocol, which consists of three sessions. Finally, patients will undergo a third evaluation (T3) after completing the treatment. Patients will undergo assessment before and after each music therapy session. Before the session, they will report their physical and emotional state, as well as their memory of the previous session's effects. After the session, they will be evaluated on their physical and emotional state, as well as the perceived effects of the current session. The therapy will consist of three individual sessions.
干预措施: MERAKI_PC (Behavioral)
结局指标
主要结局
Change in emotional distress (T1, T2, T3 and T4)
时间窗: Baseline up to 1 month
The patient's overall rating of emotional distress (distress) experienced can be measured using a single-item visual analogue scale that scores from 0 to 10.
Change in Anxiety and Depression Symptomatology (T1, T2 and T4)
时间窗: Baseline up to 1 month
HADS: This instrument evaluates affective disorders in non-psychiatric hospital settings. It comprises 14 items with a 4-point Likert-type response format (ranging from 0 to 3). Higher scores indicate more severe symptoms of anxiety and depression.
Change in Quality of Life (T1, T2 and T4)
时间窗: Baseline up to 1 month
EORTC QLQ-C30. It is the most widely used quality of life questionnaire in clinical trials in Europe. It is a cancer-specific questionnaire consisting of 30 items assessing quality of life. Higher scores indicate poorer quality of life for patients.
次要结局
- Change in Resilience (T1 and T4)(Baseline up to 1 month)
- Change in Spirituality (T1 and T4)(Baseline up to 1 month)
- Charlson Comorbidity Index (CCI)(Baseline)
- Change in Social Suport (T1 and T4)(Baseline up to 1 month)
- Change Knowledge of the disease (T1 and T4)(Baseline up to 1 month)
- Pfeiffer Short Form Mental State Questionnaire, SPMSQ(Baseline)
- Barthel Index(Baseline)
研究者
M. Antonia Pérez-Marín
Associate Professor
University of Valencia