此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Relational Music Therapy Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures

2026年6月25日 更新者:Anglia Ruskin University

Relational Regulation: A Relational Approach to Music Therapy-based Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures

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.

研究概览

详细说明

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:

  1. How does music therapy-based procedural support influence the parent-child connection, co-regulation, communication, and mutual support during medical procedures?
  2. How does repeated personalised music therapy-based procedural support influence emotional regulation, coping and resilience in children facing frequent medical procedures?
  3. How does music therapy-based procedural support influence parental perception of involvement, agency, and competence during their child's medical procedures?
  4. How do changes in parental agency, competency, and co-regulation relate to observed outcomes in the child's coping, resilience, and regulation?

Study design:

The study uses a qualitative-dominant mixed-methods multiple case series design with repeated measures. Between 5 and 10 parent-child dyads undergoing repeated needle-based procedures in an in-patient setting will participate. Participants will include children aged 5-12 years, alongside a parent or primary caregiver. Participants will receive personalised music therapy-based procedural support delivered by the researcher, a qualified music therapist. The intervention includes two to five preparatory sessions for initial meeting, introduction and familiarisation with the music therapy intervention, and planning and preparation for procedures. It will also include two or more music-supported medical procedures. Data will be collected at three key time points: (1) baseline, (2) during intervention, and (3) post-intervention. Data will be collected using a combination of qualitative and quantitative methods, including semi-structured interview with parents/primary caregiver, and arts-based sessions with children, researcher-therapist observational notes, structured observational measures, and brief questionnaires assessing parental sense of competence, child anxiety and distress, and parent-child relational interaction.

All qualitative data within each case will be analysed using narrative and reflexive thematic analysis. All quantitative outcome measures will be used descriptively to support the interpretation of patterns within and across the cases. If relevant, plans for inferential analysis will be further discussed with supervisory team and statistician. A cross-case synthesis will be conducted, identifying recurring themes across cases, linking any parent-child relational processes to observed behavioural and emotional outcomes.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Nina-Sofie T Halvorsen, MA Music Therapy
  • 电话号码:+4407907361997
  • 邮箱:nth108@prg.aru.ac.uk

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Music Therapy-Based Procedural Support (MTPS)
Participants (5-10 parent-child dyads) will receive personalised music therapy-based procedural support (MTPS), delivered by the researcher (a qualified music therapist). The intervention includes 2-5 preparatory music therapy sessions and music-supported assistance during two or more medical procedures. The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures.

Each participating dyad will take part in 2-5 preparatory music therapy sessions to familiarise them with the MTPS intervention. These sessions:

  • Introduce the child and parent to personalised music-based strategies.
  • Help the therapist understand what kinds of sounds, rhythms, or musical approaches help the child feel safe and regulated.
  • Give the parent tools to support their child's coping.

During two or more of the child's routine medical procedures, the music therapist will be present to provide real-time music therapy-based support. This may include singing, rhythmic grounding, breathing with music, or familiar musical elements chosen with the family.

The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Parent-child relational co-regulation and interaction
大体时间: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.

From enrolment to the end of intervention period at 20 weeks

次要结果测量

结果测量
措施说明
大体时间
Parental sense of competence
大体时间:From enrolment until end of intervention period at 20 weeks
Parent-reported sense of competence and confidence in supporting their child, measured using the Parenting Sense of Competence Scale-Revised (PSOC-R). Scores are rated on a 6-point scale with possible range 16-96, where 74-96 = high self-confidence, 61-73 = moderate self-confidence, and 16-60 = low self-confidence.
From enrolment until end of intervention period at 20 weeks
Child anxiety and procedural distress
大体时间:From enrolment until end of intervention period at 20 weeks
Child self-reported anxiety/distress related to medical procedures, measured using the Faces Anxiety Scale. Scores are recorded using an ordinal scale of facial expressions representing increasing anxiety, with higher scores indicating greater anxiety/distress.
From enrolment until end of intervention period at 20 weeks
Child emotional state
大体时间:From enrolment until end of intervention period at 20 weeks
Child self-reported emotional experience during medical procedures, assessed using the Blob Tree visual scale. The child select figures that best represent their emotional state and experience, with responses interpreted qualitatively and, where appropriate, categorised into ordinal groups.
From enrolment until end of intervention period at 20 weeks
Child perception of relational support and co-regulation
大体时间:From enrolment until end of intervention period at 20 weeks
Child self-reported experience of relational support and co-regulation with their parent during procedures, assessed using a brief, developmentally adapted measure informed by the Security Scale. The measure consists of simple, age-appropriate questions with responses recorded using an ordinal visual scale of facial expressions representing decreasing agreement with the question statement, with higher scores indicating greater sense of relational support and co-regulation.
From enrolment until end of intervention period at 20 weeks
Child coping and adaptation
大体时间:From enrolment until end of intervention period at 20 weeks
Child coping strategies and adaptive responses to repeated medical procedures, assessed through qualitative analysis of parent interviews, child arts-based sessions, and researcher-therapist field notes.
From enrolment until end of intervention period at 20 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月25日

首次发布 (实际的)

2026年7月2日

研究记录更新

最后更新发布 (实际的)

2026年7月2日

上次提交的符合 QC 标准的更新

2026年6月25日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • ETH2526-2528

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Due to small sample size and the qualitative, relational nature of the data, there is a risk of indirect identification of participants even after anonymisation. The dataset includes information from a vulnerable paediatric population. Findings will be shared in aggregated and fully anonymised form through publications and doctoral thesis.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅