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Effectiveness of Musical Training in Children Surviving Brain Tumours

2019年2月26日 更新者：The University of Hong Kong

Effectiveness of Musical Training in the Improvement of the Neurocognitive Function and Psychological Well-being of Children Surviving Brain Tumours

This study aims to examine the effects of musical training on improving the neurocognitive function and psychological well-being of children surviving brain tumours. Half of the participants will receive weekly 45-minute lessons on musical training for one year (52 weeks) while the other half are the placebo controls.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Children surviving brain tumours have the highest risk of suffering neurocognitive late effects, such as impairment of intellectual development and deficits in attention and concentration, working memory, processing speed and executive function. Such effects severely affect their levels of academic achievement, psychosocial function and quality of life. Musical training is considered to have potential for treating neurocognitive impairment,mostly because the extensive brain networks engaged in musical training can induce substantial neuroplasticity changes in cortical and subcortical regions of motor, auditory and speech processing networks. A review of musical training for neuro-rehabilitation revealed that it can enhance motor recovery and neuroplasticity after stroke and improve motor deficits observed in Parkinson's disease. A growing body of evidence points to the beneficial effects of musical training on the cognitive development of children. The results of a longitudinal study on the effects of musical training on children's brain and cognitive development demonstrated that such training results in long-term enhancement of visualspatial, verbal and mathematical performance. Moreover, engaging in musical practice in childhood predicts academic performance and IQ at the university level. Thus, there appears to be some support for the effects of music lessons on intellectual development.

Nevertheless, although musical training is popular and is considered to be a beneficial intervention in the treatment of neurocognitive impairment, longitudinal studies that examine the efficacy of music-making in clinical settings are limited. Importantly, there is to date no study that examines the effects of musical training on induction of neuroplasticity in childhood cancer survivors with neurocognitive impairment. There is an imperative need for rigorous empirical scrutiny of the ability of musical training, in particular, to achieve neuroplasticity and thus promote the cognitive function and psychological well-being of children surviving brain tumours.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Hong Kong、中国
        • The University of Hong Kong

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 19年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • surviving germ cell tumours of the brain
  • be aged from 7 to 19 years
  • be able to speak Cantonese and read Chinese
  • have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)
  • have completed treatment for at least two months

Exclusion Criteria:

  • have undertaken or are undertaking (at the time of the intervention) the study of a musical instrument following their cancer diagnosis
  • with evidence of cancer recurrence or second malignancy in their medical records

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Experimental group
In addition to medical follow-up, the subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation. Qualified orchestral performers will provide the musical training. Training will start at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song). The subjects will continue on to the next level if they successfully pass the relevant test; those who do not will be encouraged to repeat test.
行为的：musical training
The subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation.
安慰剂比较：Placebo Control group

The subjects will receive medical follow-up according to the schedule of the oncology units.

They will receive the same amount of time and attention as those in the experimental group but not in a way designed to have any specific effect on the outcome measures. They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).
行为的：tutoring classes
They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).

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
Change in neurocognitive function from baseline at 12 month follow-up between intervention and control group
大体时间：12 month follow-up

Subjects' IQ scores will be obtained at 12 months after starting the intervention using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older.

In addition, the neuropsychological profile of each subject will also be examined at 12 months after starting the intervention. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.
12 month follow-up

次要结果测量

结果测量
措施说明
大体时间
neurocognitive function at baseline between intervention and control group
大体时间：baseline

Subjects' IQ scores will be obtained at baseline using the Hong Kong Wechsler Intelligence Scales for Children (HK-WISC) for subjects younger than 16 years of age and the Wechsler Adult Intelligence Scale - Revised (WAIS-R) for those aged 16 years and older.

In addition, the neuropsychological profile of each subject will also be examined at baseline. A comprehensive neuropsychological assessment is usually conducted on a one on-one basis with standardised procedures.
baseline
self-esteem at baseline between intervention and control group
大体时间：baseline

The subjects' self-esteem will be assessed at baseline, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).

The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem. Participants will be asked to respond to the Chinese version of the RSES at baseline.
baseline
Change in self-esteem from baseline at 6 month follow-up between intervention and control group
大体时间：6 month follow-up

The subjects' self-esteem will be assessed at 6 months after starting the intervention, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).

The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem.Participants will be asked to respond to the Chinese version of the RSES at 6 months after starting the intervention.
6 month follow-up
Change in self-esteem from baseline at 12 month follow-up between intervention and control group
大体时间：12 month follow-up

The subjects' self-esteem will be assessed at 12 months after starting the intervention, using the Chinese version of the Rosenberg Self-Esteem Scale (RSES).

The RSES is designed to measure the global self-esteem of children and adolescents. The scale comprises 10 items, rated using a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with total possible scores ranging from 10 to 40. Higher scores indicate higher levels of self-esteem.Participants will be asked to respond to the Chinese version of the RSES at 12 months after starting the intervention.
12 month follow-up
quality of life at baseline between intervention and control group
大体时间：baseline
The subjects' quality of life will be assessed at baseline, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life.Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at baseline.
baseline
Change in quality of life from baseline at 6 month follow-up between intervention and control group
大体时间：6 month follow-up
The subjects' quality of life will be assessed at 6 months after starting the intervention, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life. Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at 6 months after starting the intervention.
6 month follow-up
Change in quality of life from baseline at 12 month follow-up between intervention and control group
大体时间：12 month follow-up
The subjects' quality of life will be assessed at 12 months after starting the intervention, using the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0). The PedsQL is designed to measure children's healthrelated quality of life. It comprises 23 items rated on a 5-point Likert scale. These items are categorised into four domains: physical functioning (eight items), emotional functioning (five items), social functioning (five items) and school functioning (five items). The total possible range of scores is from 0 to 100, with higher scores indicating better quality of life. Participants will be asked to respond to the Chinese version of the PedsQL 4.0 at 12 months after starting the intervention.
12 month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Hong Kong

调查人员

  • 首席研究员：Ho Cheung William Li、The University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年1月1日

初级完成 (实际的)

2018年6月30日

研究完成 (实际的)

2018年6月30日

研究注册日期

首次提交

2016年4月26日

首先提交符合 QC 标准的

2016年4月26日

首次发布 (估计)

2016年4月28日

研究记录更新

最后更新发布 (实际的)

2019年2月28日

上次提交的符合 QC 标准的更新

2019年2月26日

最后验证

2019年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • UW16-023

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

孩子的临床试验

musical training的临床试验

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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