Ascolto Passivo di Musica Nella Malattia Cerebrovascolare Acuta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Improvement in anxiety/depression levels (HADS score) between baseline and discharge.
研究概览
简要总结
The aim of the study is to investigate whether passive music listening during the acute phase of stroke hospitalization is a feasible and acceptable intervention that can improve the patient's psychophysical well-being, reduce anxiety and depression indicators, and improve the patient's perception of their overall health status. Secondly, the effects during hospitalization on physiological parameters, pain perception, quality of sleep, and the use of sedative, antidepressant, or anxiolytic medications will be evaluated. Finally, it will be assessed whether passive music listening is also associated with an improvement in cognitive functions.
The clinical trial is a prospective, randomized, controlled, open-label, single-center study with parallel cohorts.
Subjects with acute cerebrovascular disease (ischemic stroke, hemorrhagic stroke) hospitalized in the Neurology-Stroke Unit at San Raffaele Hospital in Milan will be recruited.
Enrolled subjects will be randomly assigned to 2 groups:
- Group 1: regular music listening starting since the acute phase of hospitalization (between 24 and 96 hours after symptom onset), continuing post-discharge for a total of 3 months.
- Group 2: no regular music listening.
Measurements of psychophysical well-being, anxiety and depression scales, and cognitive functions will be performed at three different time points (baseline, discharge, and 3 months post-ischemic event during the routine follow-up visit as per standard care).
The primary outcome of the study are:
- To evaluate whether passive music listening during hospitalization is associated with an improvement in anxiety/depression levels as measured by the Hospital Anxiety and Depression Scale (HADS).
- To investigate whether passive music listening during hospitalization is associated with an improvement in the patient's perception of their overall health status as measured by the Italian version of the EQ-VAS (EuroQol Visual Analog Scale).
- To assess the feasibility and acceptability of the intervention by measuring the percentage of patients who refuse to participate in the study and the drop-out rate during the hospitalization phase, the percentage of days with music listening during hospitalization, and the total amount of listening hours; through a feasibility, acceptability, and care appreciation questionnaire.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •time of enrollment greater than 24 hours and less than 4 days from onset of acute cerebrovascular disease
- •native Italian speaker
- •able to cooperate according to the following criteria:
- •NIHSS stroke severity score at enrollment <
- •No impairment in alertness, orientation, or language that would prevent adequate communication (NIHSS score <2 for items 1a, 1b, 1c, 9, 10).
- •No known pre-existing severe or moderate cognitive decline (CDR<2).
- •potentially able to continue music listening after discharge.
- •papable of giving informed consent for the study.
排除标准
- •Deafness and/or significant hearing loss and/or significant visual impairment and/or illiteracy.
- •Major psychiatric illness.
- •Other conditions that, in the investigator's judgment, would prevent compliance with the protocol during hospitalization or the post-hospitalization phase.
研究组 & 干预措施
REGULAR MUSIC LISTENING
Patients randomized into this arm are provided with tablet and earphones for regular music listening during hospital stay (1 hour per day in average). After discharge, patients are instructed how to continue regular music listening till the follow-up visit. Patients are required to maintain a daily music listening diary to be presented at the follow-up visit.
干预措施: Regular music listening (Other)
NO REGULAR MUSIC LISTENING
Patients randomized into this arm do not receive instrumentation for regular music listening during hospital stay. At discharge, patients in this arm are not required to perform regular music listening.
结局指标
主要结局
Improvement in anxiety/depression levels (HADS score) between baseline and discharge.
时间窗: Baseline vs. discharge (up to 30 days)
Hospital Anxiety and Depression Scale (HADS), total score ranges between 0-21, with higher values indicating higher levels of anxiety/depression.
Improvement in the patient's perception of overall health status between baseline and discharge (EQ-VAS).
时间窗: Baseline vs. discharge (up to 30 days)
EuroQol-visual analogue scales (EQ-VAS). The EQ-VAS is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Feasibility and acceptability during hospitalization (Percentage of patients who refuse to participate in the study)
时间窗: Baseline
Percentage of patients who refuse to participate in the study
Feasibility and acceptability during hospitalization (percentage of drop-outs).
时间窗: Baseline-discharge (up to 30 days)
percentage of drop-outs.
Feasibility and acceptability during hospitalization (percentage of days and total hours of music listening during the hospitalization phase).
时间窗: Baseline-discharge (up to 30 days)
percentage of days and total hours of music listening during the hospitalization phase.
次要结局
- Improvement in anxiety/depression levels (HADS score)(3 months (+/- 1 month) follow-up visit)
- Improvement in the patient's perception of overall health status (EQ-VAS).(3 months (+/- 1 month) follow-up visit)
- Feasibility and acceptability (percentage of drop-outs).(3 months (+/- 1 month) follow-up visit)
- Evaluation of cognitive functions through MoCA test(Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit)
- Evaluation of cognitive functions through Stroop test(Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit)
- Evaluation of cognitive functions through delayed story recall(Basline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit)
- Patient perception of health status related to mobility, usual activities, anxiety, depression, and pain (EQ-5D-3L Italian version).(Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up)
- Patient perception of sleep quality (ISI insomnia severity index, Italian version).(Baseline vs. discharge (up to 30 days) vs. 3 months (+/- 1 month) follow-up visit)
- Blood pressure, pre- and post-listening.(hospitalization phase (discharge-baseline, up to 30 days))
- Daily average number of administrations of sedatives, anxiolytics, and antidepressants.(hospitalization phase (discharge-baseline, up to 30 days))
- Heart rate, pre- and post-listening.(hospitalization phase (discharge-baseline, up to 30 days))
- Feasibility and acceptability (percentage of days and total hours of music listening).(3 months (+/- 1 month) follow-up visit)
研究者
GIACOMO GIACALONE
MD PhD
IRCCS Ospedale San Raffaele