Relational Regulation: A Relational Approach to Music Therapy-based Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Parent-child relational co-regulation and interaction
研究概览
简要总结
This study explores how personalised music therapy can support children and their parents during repeated medical procedures, such as blood tests or injections. Many children find these procedures painful or frightening, and repeated experiences can lead to high anxiety and difficulty coping. Parents often feel distressed as well, which can affect how well they are able to support their child. Because children and parents regulate each other emotionally, helping both members of the pair is important for reducing distress.
This study aims to explore how personalised music therapy-based procedural support (MTPS) influences the relational and emotional processes that help children and their parents cope, regulate, and build resilience during repeated medical procedures.
详细描述
Background:
Repeated invasive procedures in paediatric healthcare settings, such as blood tests and injections, are frequently perceived as major stressors and can cause significant distress and anxiety in children. Procedural anxiety and acute distress often stems from prior medical trauma and can result in heightened pain perception, emotional dysregulation, and refusing, avoiding, or delaying healthcare later in life. This distress often extends to parents, who also report high levels of distress before and during medical procedures, affecting their ability to support their child. Studies show that low parental coping often leads to lower coping in the child and affects procedural experience and wellbeing. This suggests that child regulation and parental regulation during medical procedures are intertwined through attunement and synchrony. It also highlights the dyadic nature of coping and regulation, how parent regulation directly influences child regulation, and vice versa.
The study aims to answer these research questions:
- How does music therapy-based procedural support influence the parent-child connection, co-regulation, communication, and mutual support during medical procedures?
- How does repeated personalised music therapy-based procedural support influence emotional regulation, coping and resilience in children facing frequent medical procedures?
- How does music therapy-based procedural support influence parental perception of involvement, agency, and competence during their child's medical procedures?
- How do changes in parental agency, competency, and co-regulation relate to observed outcomes in the child's coping, resilience, and regulation?
Study design:
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
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patient (ages 5-12) undergoing recurring needle procedures (venipuncture, intravenous (IV) cannulation, subcutaneous injections, intramuscular (IM) injections, Port-a-Cath, lumbar punctures, and bone marrow transplant, aspiration or biopsy)
- •Parents or caregiver of a paediatric patient (ages 5-12) undergoing recurring needle procedures.
- •Willing to participate in music therapy-based sessions.
- •Able to complete brief questionnaires and/or take part in an interview.
- •Paediatric inpatient, outpatient, or palliative care unit.
排除标准
- •Patients currently under heavy sedation or anaesthetic medication that impairs consciousness during data collection.
- •Medically unstable or emergency care patients where participation may interfere with clinical care.
- •Non-English or non-Norwegian speakers where language barriers may pose difficulties in participants understanding study information, and issues in interpretation and analysis of collected data.
- •Patients with severe cognitive or developmental impairment making meaningful engagement with the intervention difficult.
- •Severe behavioural/psychiatric conditions that will make safe participation difficult or impossible.
结局指标
主要结局
Parent-child relational co-regulation and interaction
时间窗: From enrolment to the end of intervention period at 20 weeks
Primary outcome measures in this study are relational and emotional co-regulation and interaction between parent and child. These will be assessed using a study-specific structured observational framework, informed by attachment theory and the Emotional Availability conceptual framework (Biringen). Observations will be recorded through researcher-therapist field notes and brief structured post-session reflections completed immediately following each session, capturing: * parent attunement and responsiveness * child emotional regulation and distress expression * dyadic synchrony and interaction patterns * key co-regulation and rupture-repair moments * the role of music therapy in relational processes Observational findings will be analysed qualitatively and triangulated with parent interviews, child arts-based data, and field notes, to provide a comprehensive understanding of relational processes.
次要结局
- Parental sense of competence(From enrolment until end of intervention period at 20 weeks)
- Child anxiety and procedural distress(From enrolment until end of intervention period at 20 weeks)
- Child emotional state(From enrolment until end of intervention period at 20 weeks)
- Child perception of relational support and co-regulation(From enrolment until end of intervention period at 20 weeks)
- Child coping and adaptation(From enrolment until end of intervention period at 20 weeks)