Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- Postpartum depression
研究概览
简要总结
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.
The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.
详细描述
This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby.
The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.
- •Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)
- •Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)
排除标准
- •Parents/caregivers with known auditory problems that prevent participation in MT.
- •Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.
- •Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.
结局指标
主要结局
Postpartum depression
时间窗: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.
Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). This scale has values between 0 to 30 points. Higher scores mean a worse outcome.
次要结局
- Anxiety(It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.)
- Well-being(It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.)
- Resilience(It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.)
- Stress(It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.)
- Coping(It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.)
研究者
Claudia Aristizábal
Director
Sanitas University