跳至主要内容
临床试验/NCT06315049
NCT06315049已完成不适用

Music Therapy to Reduce Anxiety in Community-Dwelling Individuals With Severe Mental Illness

Universitat Politècnica de València2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年6月26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
发起方
入组人数
14
试验地点
2
主要终点
IDARE test

研究概览

简要总结

This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session.

详细描述

This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with SMI (bipolar disorder and schizophrenia).

The general objective is to evaluate the effectiveness of the Nursing Interventions Classification (NIC) activity, known as Music Therapy, as a therapeutic modality complementary to psychopharmacological treatment for reducing anxiety in patients diagnosed with SMI. The specific research questions are:

Q1: How much do music interventions affect the objective values of vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR)) in people diagnosed with SMI? Q2: How much does the subjective perception of anxiety change after a music intervention with people diagnosed with SMI? This pilot study is quasi-experimental analytical research of type cross-sectional. It was conducted with outpatients diagnosed with SMI. All patients were recruited from a community mental health center in Valencia (Spain). Fourteen patients regularly attended an occupational activities rehabilitation workshop. All of them were recruited: after the workshop, they participated in the music therapy sessions. All the participants had been previously diagnosed with SMI (schizophrenia, bipolar disorder) by their psychiatrist. Ten participants lived with their parents, and four lived alone and lacked familiar support. None of the participants worked. All had total permanent disability, legally granted, and therefore could not carry out any work activity.

All patients who met the inclusion/exclusion criteria and voluntarily accepted to participate were recruited: 14 patients (3 people with bipolar disorder, 11 people with schizophrenia) participated in the study (with a total sample of 10 group sessions and 150 individual data collection interviews). None of the patients had any previous music therapy experience. All patients followed unique treatments, and this study was an opportunity to motivate their social interaction through music and to study its impact on anxiety.

The patients' psychiatrists determined the cognitive competency of the patients and decided the convenience of their participation.

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
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with SMI (schizophrenia, bipolar disorder) according to the Diagnostic and Statistical Manual of Mental Disorders DSM-V-TR
  • currently in outpatient psychiatric treatment in their corresponding mental health unit
  • acceptance to enter the study (informed consent); if legally incapacitated, authorization from the patient's legal guardian
  • ability to understand the questions in anxiety questionnaires
  • between 35 and 50 years of age, to focus the study on a specific population (young adulthood above 35 years and middle adulthood) and to narrow the age range so that they can share common recall of musical memories

排除标准

  • suffering from a dual pathology (diagnosis of mental illness and, at the same time, substance abuse) and who were also in the dependency phase
  • affected by some type of degenerative disease (dementia, Alzheimer's, etc.)
  • presence of positive psychotic symptoms or behavioral disorganization susceptible to admission in the mental health unit

研究组 & 干预措施

Music therapy group

Experimental

It is formed from all the participants in the study. They participated in the music therapy sessions.

干预措施: Music therapy (Other)

结局指标

主要结局

IDARE test

时间窗: 1 year

Inventario de la ansiedad rasgo-estado (IDARE) is the Spanish version of the State-Trait Anxiety Inventory (STAI), commonly used to obtain a meaningful measure of state anxiety (SA) and trait anxiety (TA).

HR

时间窗: 1 year

Heart rate

DBP

时间窗: 1 year

Diastolic blood pressure

SBP

时间窗: 1 year

Systolic blood pressure

RR

时间窗: 1 year

Respiratory rate

次要结局

未报告次要终点

研究者

发起方
Universitat Politècnica de València
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Francesc Silva Galiana

PhD.

Universitat Politècnica de València

研究点 (2)

Loading locations...

相似试验