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临床试验/NCT04454736
NCT04454736Unknown不适用

Psychological and Biological Responses to Choral Singing in Mentally Ill, Socially Underprivileged and Privileged Healthy Children and Adolescents: An Open, Single-Arm, Controlled Study

University of Salzburg3 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
135
试验地点
3
主要终点
Change Short-Term Immune Function from pre- to post singing session over six months

研究概览

简要总结

Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase), immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood, social contacts, emotional and social competence, self-esteem, and quality of life) responses in mentally ill and healthy children and adolescents (N=135, age range 10 -18).

Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three hour creative workshops every two weeks.

详细描述

Background: Biopsychological responses to music-related activities (MRA) were examined in various naturalistic settings in adults. Group singing in particular seems to be associated with positive biopsychological outcomes. There is also an emerging view that MRA may play an important role for youth with mental disorders. However, longitudinal research on biopsychological responses to MRA in different clinical and healthy populations among children and adolescents is lacking.

Method: Children and adolescents (age range 10-18) under psychiatric treatment at the Department of Child and Adolescents Psychiatry in Salzburg (n=45), healthy children and adolescents from a school in Salzburg (n=45), and members from the Vienna Boys Choir (n=45) in Austria will be recruited to take part in the study. Subjective measures (mood, stress experience) will be taken pre- and post singing sessions once a week throughout six months. Additionally, salivary biomarkers (cortisol, alpha amylase and IgA), social contacts, and quality of life are assessed. Emotional competence, social competence, self-esteem, and chronic stress levels are measured at the beginning, after three months, at the end, and in a follow-up of the study.

The group of child and adolescent psychiatry taking part in the creative workshops will be additionally assessed via questionnaires regarding emotional regulation, self-esteem, and art experience before and after every workshop. Furthermore, some individuals of the child and adolescent psychiatry group will undergo fMRI evaluation of the brain before and after completion of all creative interventions.

Conclusion: Singing and other creative activities are suggested to benefit mental and physical health in children and adolescents. However, despite the current knowledge, the researchers must better understand the biopsychological mechanisms underlying choral singing in order to determine its full potential, particularly for vulnerable populations. This is the first study to investigate this issue in this population.

研究设计

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

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(Clinical N):
  • •Written consent to study participation;
  • •Gender: male, female, different;
  • •Age: children and adolescents aged ≥ 10 and ≤ 18 years;
  • •Diagnosis of a psychiatric disorder according to ICD-10;
  • •Patients are admitted regardless of medication status and are allowed to the medication will continue to be used during the study;
  • •Additional therapies and medication are recorded and are not an exclusion criterion;
  • •Musical skills or a certain musical background are not required
  • •Inclusion Criteria (Healthy N):
  • •Written consent to study participation;
  • •Gender: male, female, different;
  • •Age: children and adolescents aged ≥ 10 and ≤ 18 years;
  • •Musical skills or a certain musical background are not required

排除标准

  • •(Clinical N):
  • •Age: children and adolescents aged <10 years and > 18 years;
  • •Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize;
  • •Patients with acute externalizing behavior or self-harm/suicidality;
  • •Existing alcohol addiction or abuse of illegal drugs;
  • •Exclusion Criteria (Healthy N):
  • •Age: children and adolescents aged <10 years and > 18 years
  • •Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize

研究组 & 干预措施

SBGmentdis

Experimental

Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria

干预措施: "Amateur" Group Singing (Behavioral)

SBGhealthy

Experimental

Healthy children and adolescents from schools in Salzburg, Austria

干预措施: "Amateur" Group Singing (Behavioral)

VIEhealthy

Experimental

Members from the Vienna Boys Choir, Austria

干预措施: "Professional" Group Singing (Behavioral)

结局指标

主要结局

Change Short-Term Immune Function from pre- to post singing session over six months

时间窗: every two weeks pre- and post singing sessions for six months

Biological Marker: Salivary Immunoglobulin A

Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months

时间窗: every two weeks pre- and post singing sessions for six months

Biological Stress Marker: Salivary Cortisol

Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months

时间窗: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months

Biological Stress Marker: Hair Cortisol

Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months

时间窗: every two weeks pre- and post singing sessions for six months

Salivary Alpha-Amylase

次要结局

  • Life Quality(once a month for six months)
  • Mood(every week pre- and post singing sessions for six months)
  • Performance Anxiety(once at the beginning of the study, once after 6 months)
  • Emotional Skills(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Self-Esteem(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Evaluation of the choir session(every week post singing sessions for six months)
  • Stress Perception(every week pre- and post singing sessions for six months)
  • Psychological Stability (children view)(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Emotional Control(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability(At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders)
  • Psychological Stress(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Social Skills(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Chronical Stress(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Psychological Stability (parents view)(at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months)
  • Prosocial Behavior(every two weeks post singing sessions for six months)
  • Current emotional state(Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders)

研究者

发起方
University of Salzburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Katarzyna Grebosz-Haring

Senior Scientist, Principal Investigator

University of Salzburg

研究点 (3)

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