A Pilot Study to Evaluate the Feasibility of Family-Centered Songwriting in Pediatric Palliative Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Intervention feasibility and recruitment log
研究概览
简要总结
This study evaluates the feasibility and efficacy of a family-centered songwriting intervention for cognitively-impaired children referred to a palliative care service.
详细描述
Music-based interventions have previously been shown to reduce psychological distress in children with life-threatening conditions. However, children with cognitive impairment are frequently excluded from these studies. Our study will evaluate the efficacy a family-centered songwriting intervention for the following outcomes: child psychological and physical symptoms, parent psychological distress, and family environment.
Following recruitment, parent-child dyads will undergo 4 sessions with a licensed music therapist (anticipated to last 1 hour each). During these sessions, families and their children will select a song and engage in a songwriting process which includes various physiologic sounds from the child (i.e. heart rate, breathing). At the conclusion of these four sessions, a music DVD will be produced and delivered to the family.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children ages 7-17 years
- •cognitive impairment (T-score of 40 or below on the PROMIS Parent-Proxy Cognitive Function)
- •receiving palliative/complex care
- •progressively declining disease
- •ability to hear.
- •parents 18 years of age and older
- •parent without cognitive impairment
- •parent able to speak/understand English
排除标准
- 未提供
结局指标
主要结局
Intervention feasibility and recruitment log
时间窗: throughout study completion, an average of 1 year
Number of enrolled participants who complete all phases of study
次要结局
- Parent Proxy Physical Stress Experiences(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
- Parent Proxy Sleep Disturbance Short Form(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
- Parent Proxy Anxiety(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
- Parent Anxiety(Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.))
- Parent Proxy Depressive Symptoms(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
- Parent Sleep Disturbance(Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.))
- Change in cortisol levels(Before and after each songwriting intervention session throughout study completion, an average of 1 year)
- Parental Perceived Stress (NIH Toolbox)(Will be obtained at Time 1 (baseline, at recruitment), at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.))
- Parent Satisfaction(Will be obtained at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline), and at Time 3 (one month following death of child, if death of child occurs during study period.))
- Parent Proxy Psychological Stress Experiences(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
- Family Relationships(Will be obtained at Time 1 (baseline, at recruitment) and at Time 2 (at completion of intervention, estimated at 3-4weeks following baseline))
研究者
Terrah Akard
Associate Professor
Vanderbilt University