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临床试验/NCT00824681
NCT00824681终止1 期

Sound Of Family Together (S.O.F.T.) Music Program: A Randomized-Controlled Study to Investigate the Effect of Music Therapy on the Coping and Adjustment of Children of Adults With Major Burns

MetroHealth Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
1 期
状态
终止
入组人数
30
试验地点
2
主要终点
Anxiety level

研究概览

简要总结

The purpose of this study is to investigate the efficacy of music therapy in assisting with the coping and adjustment of children of adults with major burns. The investigators hypothesized that there will be a significant decrease in anxiety levels between those children who participated in music therapy compared to non-participants.

详细描述

The Sound Of Family Together (S.O.F.T.) Music Program was introduced on a 14-bed burn intensive care unit to provide an avenue for communication between adults with major burns and their children. In adherence with unit policies, children under the age of 16 are only allowed onto the unit under very special circumstances, e.g. patient is under DNR status. This restriction may translate into a prolong absence between the patients and their young children; which may result in emotional and psychological stress factors such as separation anxiety, feelings of abandonment, and rejection of the parent when the patient is being discharged to home. Children who participate in the S.O.F.T. Music Program will record and produce an audio CD for their hospitalized parent/grandparent. The contents of the CD might include original songs, poems, and special messages created by the children. Pre and post tests results will determine the efficacy of the program to decrease anxiety levels in the children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child's age between 6 - 14 years
  • Child or grandchild of patient
  • Child with limited visitation
  • Adequate hearing, with correction
  • Consenting non-hospitalized adult family member (NHAFM) speak/read English
  • Child speak/read English
  • Major physical or mental illness or disability does not interfere with ability to communicate for both consenting NHAFM and child

排除标准

  • Child's age below 6 years and above 14 years
  • Not the child or grandchild of patient
  • Child with unlimited visitation
  • Hearing loss that interferes with ability to communicate
  • NHAFM does not speak/read English
  • Child does not speak/read English
  • Major physical or mental illness or disability interferes with ability to communicate for both consenting NHAFM and child
  • Patient on observation status, i.e. only one overnight stay

结局指标

主要结局

Anxiety level

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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相似试验

Effect of Music Therapy on Families of Burn Patients | 临床试验