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临床试验/NCT06343662
NCT06343662终止不适用

Meraki: Music Therapy Protocol for People With Acquired Brain Injury

University of Valencia2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
27
试验地点
2
主要终点
Change in Discomfort ( Baseline (3 Assessments), Pre- Post)

研究概览

简要总结

The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.

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

入选标准

  • Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index > 60).
  • Be over 18 years of age.
  • The participant or their relatives have signed the informed consent form.
  • They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.

排除标准

  • Failure to obtain informed consent
  • The Barthel Index score is below 60, indicating functional dependency.

研究组 & 干预措施

No Intervention: Control Group

No Intervention

Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).

Experimental group

Experimental

Patients admitted to the brain injury unit will participate in a music therapy protocol starting one week after admission. Prior to the group session, three evaluations will be conducted over six days. Post-treatment assessments will also be conducted to enable longitudinal evaluation of the patient over the course of a week.

干预措施: MERAKI_ABI (Behavioral)

结局指标

主要结局

Change in Discomfort ( Baseline (3 Assessments), Pre- Post)

时间窗: Baseline up to 1 week

The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. The Discomfort Observation Scale (DOS) is a tool used to assess discomfort in patients with severe cognitive impairment in end-of-life situations. It consists of nine items that evaluate factors such as noisy breathing, body language, facial expressions, and verbalizations. Each observation is scored dichotomously (0-1, presence-absence), resulting in a score range of 0 to 9. A higher score indicates less discomfort. The language used is clear, concise, and objective, adhering to formal register and precise word choice. The text is grammatically correct and follows conventional structure and formatting features.

次要结局

  • Pfeiffer Short Form Mental State Questionnaire, SPMSQ(Baseline)
  • Barthel Index(Baseline)
  • Charlson Comorbidity Index (CCI),(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

M. Antonia Pérez-Marín

Associate Professor

University of Valencia

研究点 (2)

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