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临床试验/NCT03399864
NCT03399864已完成不适用

Effectiveness of Musical Training in Reducing Depressive Symptoms, Enhancing Self-esteem and Quality of Life Among Hong Kong Chinese Childhood Brain Tumor Survivors - A Pilot Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.

研究概览

简要总结

This study aims to work out the effectiveness (effect size) of the musical training intervention in reducing depressive symptoms, improving self-esteem and quality of life among childhood brain tumour survivors and to examine the feasibility, appropriateness, and acceptability of implementing musical training intervention in clinical practice. Subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), while those in the control group will receive usual care.

详细描述

Musical training has been increasingly implemented to promote one's psychological well-being and cognitive functioning. For instance, to reduce depression, anxiety in psychiatric patients, to improve self-esteem and mood recognition in hospitalized adolescent patients diagnosed with "adjustment reaction to adolescence", to improve social skills of children with autism, to enhance reading skills and academic achievement in young poor readers, and to facilitate children's cognitive development. Nevertheless, the effectiveness of musical training in promoting psychological well-being, particularly to reduce their depressive symptoms and enhance self-esteem, and enhancing quality of life among the childhood brain tumour survivors is remain underexplored. It is of paramount importance to examine the effectiveness of musical training so as to ameliorate adverse disease- and treatment-related late effects, such as depression and low self-esteem, hence enhancing childhood brain tumour survivors' quality of life.

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
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Hong Kong Chinese children surviving from brain tumours with the Modified Mini-Mental Scale (MMSE) score of 18 or above
  • be aged between 7 and 16 years
  • able to speak Cantonese and read Chinese
  • have completed treatment for at least two months
  • have residual function of the upper extremities (i.e. be able to move the extremities, such as the fingers and arms, without assistance)

排除标准

  • children who have undertaken any musical training following their cancer diagnosis
  • survivors with evidence of recurrence or second malignancies
  • survivors receiving palliative care

研究组 & 干预措施

Experimental group

Experimental

Apart from receiving scheduled medical follow-up, the subjects in the experimental group will receive a weekly 45-minute lesson on musical training for 52 weeks. The musical training will be conducted by the Music Children Foundation and be implemented in a ratio of one subject to one qualified orchestral performer at the subjects' homes. A musical instrument will be assigned to each subject based on their interests and the results of the prior assessment of subjects' expiratory function and fine motor skills. The musical training will start at the lowest level, such as hitting simple notes and end at the highest level, such as playing an entire song.

干预措施: musical training (Behavioral)

Control group

Other

The subjects will receive usual care, such as medical follow-up according to the schedule of the oncology units.

干预措施: usual care (Other)

结局指标

主要结局

Change in depressive symptoms from baseline at 12-month follow-up between intervention and control group.

时间窗: 12-month follow-up

The subjects' depressive symptoms will be assessed at 12-month after starting the intervention using the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC). The CES-DC is a commonly used tool in assessing the number of depressive symptoms of children and adolescent (Radloff, 1977). It consists of 20 items which are rated on a 4-point Likert scale from 0 to 3 (0= "not at all", 1 = "a little", 2 = "sometimes", 3= "a lot") regarding the subjects' feelings and experiences of last week. A possible scores ranging from 0 to 60 will be obtained after summing up all the items. Higher scores indicate greater number of depressive symptoms experienced. The cut-off score of this scale is 16, which indicates the children or the adolescents are currently experiencing a significant level of depressive symptoms.

次要结局

  • Change in depressive symptoms from baseline at 6-month follow-up between intervention and control group(6-month follow-up)
  • Level of self-esteem at baseline between intervention and control group(baseline)
  • Depressive symptoms at baseline between intervention and control group(baseline)
  • Change in level of self-esteem from baseline at 6-month between intervention and control group(6-month follow-up)
  • Quality of life at baseline between intervention and control group(baseline)
  • Change in level of self-esteem from baseline at 12-month between intervention and control group(12-month follow-up)
  • Change in Quality of life at 12-month follow-up between intervention and control group(12-month follow-up)
  • Change in Quality of life at 6-month follow-up between intervention and control group(6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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