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临床试验/NCT04431362
NCT04431362Unknown不适用

A Single Case Experimental Design Study Exploring the Effect of Music in an Inpatient Neuropsychological Rehabilitation Setting

King's College Hospital NHS Trust0 个研究点目标入组 5 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5
主要终点
Change in the Montreal Cognitive Assessment

研究概览

简要总结

The aim is to examine whether self-selected music can improve mood (as well as cognitive function) in stroke patients at an inpatient rehabilitation unit. Additionally, the feasibility of such an intervention will be assessed.

Hypotheses:

  • The current intervention will be found to have a high feasibility.
  • Stroke patients will exhibit improved mood during the music listening intervention phase compared to their baseline phase.
  • Patients will show improvements in engagement in therapy if non-compliance was a previous issue (as demonstrated by therapist feedback regarding attendance of therapy sessions).
  • Patients will experience improved cognitive (memory) function (i.e. immediate and delayed free recall) during the intervention phase compared to baseline.

详细描述

Stroke is one of the leading causes of disability in the world. Research has shown that in the aftermath of a stroke, patients continue to experience various impairments even years after the stroke. For example, research has shown that stroke survivors continue to experience both cognitive impairments (e.g. executive dysfunction) and low mood (e.g. depression) even after more than 5 years since the stroke has passed. A further study was able to link low mood with reduced engagement in therapy, which has been found to lead patients to experience less benefits from the given therapy.

Due to the lack of supporting evidence for pharmacological and psychological treatments, music intervention was introduced with positive results being reported in regards to patients' mood and cognitive abilities. For example, one study found that stroke patients who listened to self-selected music were likely to experience a significant improvement in their mood and cognitive abilities when compared to another group who listened to audiobooks.

The current study aims to build on previous research by utilising a novel study design that has not been previously used to assess the feasibility and effectiveness of music intervention on the mood of patients located at an inpatient rehabilitation unit. The chosen design, single-case experimental design, allows researchers to take into account the individual differences of the patients, which cannot be considered when using an experimental design which needs a group of similar characteristics. In addition, by using a non-concurrent multiple baseline design, the researchers will be able to show that any changes occurring to the target behaviour (mood) will be due to the intervention itself rather than any other extraneous variables found in the environment, as three different time lengths will be used for the baseline phase (5, 10, and 15 days). The aim of the study is to provide data that support the feasibility and effectiveness of music intervention as an inexpensive and simple method for improving mood in stroke patients at an inpatient rehabilitation unit. It also aims to show similar effectiveness in increasing cognitive impairment and therapy engagement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The measures will be completed by the clinical psychologist while the diary and checklist will be done by the patients with assistance from the research student or activity coordinators.

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

入选标准

  • 18 years or older
  • Good grasp of the English Language
  • Patients at the Frank Cooksey Rehabilitation Unit or transferring to the unit from an acute stroke ward
  • Recent diagnosis of stroke using MRI or CT scans
  • Low mood; will be confirmed by the clinical psychologist on the ward using mood screens as appropriate

排除标准

  • Severe or global aphasia, which interferes with their ability to understand instructions
  • Have a diagnosis of dementia
  • Patients who lack the capacity to consent
  • The study will also aim to exclude patients who have severe cognitive impairment, as assessed by the occupational therapists and clinical psychologist on the ward using screens or functional assessment as appropriate.

结局指标

主要结局

Change in the Montreal Cognitive Assessment

时间窗: up to 6 weeks

Will help to explore changes in cognition before and after the intervention. Minimum value=0, maximum value=30, better scores mean better outcome.

Change in the Mood Likert Scale

时间窗: up to 6 weeks

Ad hoc scale made for the study for participants to rate their mood. It is a Likert scale (0 is very relaxed, 10 is very stressed). Higher score thus mean worse outcome.

Change in self-report diary

时间窗: up to 6 weeks

will assess feasibility by examining how frequently the patients are listening to music

Change in The Brain Injury Rehabilitation Trust Memory and Information Processing Battery (examines memory and information processing. Only the story recall subcategory will be used)

时间窗: up to 6 weeks

Will help to explore changes in cognition (memory) before and after the intervention Minimum value=0, maximum value=60. Better scores mean better outcome

Change in the CORE-10 mood screen

时间窗: up to 6 weeks

questionnaire measure of distress, functioning and risk

Change in self-report by therapists

时间窗: up to 6 weeks

Will help to assess patients' engagement in therapy before during and after intervention

次要结局

未报告次要终点

研究者

发起方
King's College Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

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