跳至主要内容
临床试验/NCT06028815
NCT06028815招募中不适用

Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents

University of Deusto2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Anxiety Stay and Trait

研究概览

简要总结

To evaluate the effects of a group music therapy intervention with informal caregivers of elderly people on clinical psychological symptoms, taking into account variables such as caregiver burden, anxiety and depression.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • to be the main informal caregiver of an elderly dependant
  • the dependant person has to be over 60 years of age
  • to be over 18 years of age
  • having signed the informed consent form accepting the assessment and intervention

排除标准

  • not residing in Spain
  • being under 18 years
  • having uncompensated sensory deficits that prevented the administration of the assessment protocol;
  • illiteracy.

结局指标

主要结局

Anxiety Stay and Trait

时间窗: 3 months

The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety that also is often used in research as an indicator of caregiver distress. It has 20 items for assessing trait anxiety and 20 for state anxiety, on a 4-point Likert scale. Scores range from 20 to 80, with higher scores correlating with greater anxiety

Depression

时间窗: 3 months

Assessed with the BDI-II that contains 21 items and identifies symptoms and attitudes associated with depression. Each item is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63. Higher total scores indicate more severe depressive symptoms

Health-related quality of life

时间窗: 3 months

For evaluating Health-Related Quality of Life is going to use the 36-Item Short Form Health Survey questionnaire (SF-36). The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). The correct calculation of SF-36 summary measures PCS and MCS requires the use of special algorithms. The scores obtained in this questionnaire range from 0 to 100, with 0 being the worst state of health and 100 the best state of health for the dimension assessed. Thus, the higher the score obtained, the better the quality of life of the person assessed.

Burden

时间窗: 3 months

To assess the burden, it is using the Burden Zarit Interview that is a self-report instrument that assesses the level of caregiver burden. It consists of 22 items that are assessed using a Likert-type scale, where higher scores indicate greater burnout.

次要结局

  • Coping strategies(3 months)
  • Spirituality(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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