Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
研究概览
简要总结
In the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads of infants with congenital heart disease and their parents.
This intervention will be compared with the standard of care. Infants allocated to the control group will receive standard care during admission. Standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists.
详细描述
Open label single-centre randomised controlled interventional trial. All infants with congenital heart disease (CHD) and age <28 days admitted to the neonatal and paediatric intensive care unit at the University Children's Hospital in Zurich are eligible. Infants will be allocated 1:1 to creative music therapy (CMT) and standard care using block randomization with stratification by socio-economic score (SES, <8 vs >8) and risk of CHD according to the Risk Stratification for Congenital Heart Surgery (RACHS-2). CMT will be conducted 3x/week with a minimum of ten sessions. The primary outcome is mother-infant interaction at age 6 months assessed using a video of a feeding interaction at home, coded in a blinded manner with the Parent-Child Early Relational Assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborn infants with CHD born >35 weeks of gestational and <28 days at diagnosis of CHD irrespective of severity of the heart disease
- •Admitted to Neonatal Intensiv Care Unit/Pediatric Intensiv Care Unit (NICU/PICU) at the Children's University Hospital
- •Infants with syndromes and /or confirmed chromosomal abnormalities
排除标准
- •Gestational age at birth <35 weeks, age >28 days at diagnosis of CHD
结局指标
主要结局
Mother-infant interaction as assessed by Parent-Child Early Relational Assessment (PCERA P1)
时间窗: at age 6 months
A video of a mother-infant interaction such as a feeding sequence is chosen as primary outcome. The video will be scored blinded according to the PCERA coding system. The variables/items in each scale are averaged together to form a total score between 1 and 5. Each variable/item is coded on a 5-point Likert-type scale from 1 (less positive and/or more negative affect or behaviour) to 5 (more positive and/or less negative affect or behaviour)
次要结局
- Parental mental health as assessed by Parental stress scale (PSS:NICU)(from baseline until six months age)
- Parental mental health as assessed by Post traumatic diagnostic scale DSM-5 (PDS)(from baseline until six months age)
- Paternal-infant interaction and protective factors as assessed by F-Soz U Social Support Questionnaire (FSozU)(baseline and at six months age)
- Parent-infant interaction as assessed by Maternal postnatal attachment scale (MPAS)(from baseline to six months of age)
- Parent-infant interaction as assessed by Postpartum Bonding Questionnaire (PBQ)(from baseline until six months age)
- Parent-infant interaction as assessed by Pictorial Representation of Attachment Measure(from baseline until six months age)
- Parent-infant interaction as assessed by saliva oxytocin measurements (before/after CMT intervention)(from baseline until six months age)
- Parental mental health as assessed by General health (GHQ-12)(from baseline until six months age)
- Parental mental health as assessed by Patient Health Questionnaire(from baseline until six months age)
- Parental mental health as assessed by Edinburgh Postnatal Depression Scale (EPDS)(from baseline until six months age)
- Parental mental health as assessed by Spielberger State Anxiety Scale (STAI)(from baseline until six months age)
- Parental mental health as assessed by Perceived Stress SCale (PSS-10)(from baseline until six months age)
- Socioeconomic status (SES)(baseline)
- Paternal-infant interaction and protective factors as assessed by Resilience Scale 13(baseline an at six months age)
- Paternal-infant interaction and protective factors as assessed by Big five inventory-10(baseline)
- Infant secondary outcome as assessed by Brain magnetic resonance imaging(baseline and before discharge from hospital)
- Infant secondary outcome as assessed by The Infant Behavior Questionnaire Revised (IBQ-R), Infant Temperament(at six months age)
- Infant secondary outcome as assessed by Questionnaire about screaming, feeding and sleeping (SFS)(at six months age)