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临床试验/NCT07470346
NCT07470346进行中(未招募)不适用

Music Therapy in the Management of Anxiety and Stress in the Recovery Process of People With Severe Mental Disorder in a Regional Medium-Stay Unit.

Alejando Vargas Rubio1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年3月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
12
试验地点
1
主要终点
STAI Questionnaire (State-Trait Anxiety Inventory)

研究概览

简要总结

The aim of this study is to analyze the influence of music therapy on perceived anxiety and stress, as well as its effect on the recovery process in individuals with Severe Mental Disorder who are admitted to a Regional Medium-Stay Unit.

The main questions to be addressed are:

Can music therapy produce a significant difference in anxiety levels in people with Severe Mental Disorder? Can music therapy produce a significant effect on perceived stress in people with Severe Mental Disorder? Can music therapy lead to a significant improvement in recovery process indicators in people with Severe Mental Disorder? Can a relationship be objectively established between a reduction in anxiety and perceived stress levels and an increase in recovery process indicators?

A total of 15 sessions will be carried out, and each session will last 60 minutes.

The participants will select the songs, rhythms, or sounds they want to choose according to the session theme, followed by a dialogue between the participant and the nurse.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Individuals aged 18 years or older.
  • Individuals without severe hearing impairment.
  • Individuals without cognitive deficits that would prevent them from reading or understanding the proposed documents.
  • Individuals not in a state of psychopathological decompensation.

排除标准

  • Individuals under 18 years of age.
  • Individuals with severe hearing impairment.
  • Individuals with cognitive deficits that prevent them from reading or understanding the proposed questionnaires.
  • Individuals in a state of psychopathological decompensation.

研究组 & 干预措施

Individuals with Severe Mental Disorder admitted to a Regional Medium-Stay Unit

Experimental

The study will be conducted in a Regional Medium-Stay Unit (URME) belonging to the Murcia Health Service and located in the Román Alberca Hospital complex in El Palmar (Murcia), Spain. It is a care service for people with Severe Mental Disorder who, due to circumstances derived from their mental state or arising within their social context, experience difficulties maintaining their integration in the community or receiving care in an outpatient setting, thus requiring a period of medium- or long-term hospitalization.

干预措施: Combined music therapy intervention (active and receptive) (Behavioral)

结局指标

主要结局

STAI Questionnaire (State-Trait Anxiety Inventory)

时间窗: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).

This self-administered questionnaire assesses two aspects related to anxiety: state anxiety and trait anxiety. It consists of 20 items for each subscale (state anxiety and trait anxiety), with 4 response options ranging from 0 (Not at all) to 3 (Very much). Higher scores indicate a greater level of anxiety. The Spanish validated version shows a Cronbach's alpha of 0.9 for trait anxiety and 0.94 for state anxiety.

Perceived Stress Scale (PSS) Questionnaire

时间窗: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).

This self-administered questionnaire assesses the level of perceived stress. It consists of 14 items with 5 response options ranging from 0 (Never) to 4 (Very often). Higher scores indicate a higher level of perceived stress. The validated Spanish version shows a Cronbach's alpha of 0.81

Questionnaire about the Process of Recovery (QPR-15-SP)

时间窗: This questionnaire will be administered at three time points: at baseline (day 1 of the intervention), midway through the intervention (around week 7), and at the end of the intervention (week 15).

This self-administered questionnaire assesses changes in the different dimensions of the recovery process. It consists of 15 items, each rated on a Likert scale from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate a greater level of recovery. The validated Spanish version of this scale shows a McDonald's Omega coefficient of 0.93 and a Cronbach's alpha coefficient of 0.92

次要结局

  • Satisfaction with the intervention received(At the end of the intervention, in week 15.)

研究者

发起方
Alejando Vargas Rubio
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alejando Vargas Rubio

Mental Health Nurse Specialist

Universidad de Murcia

研究点 (1)

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