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

2026년 6월 25일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Nina-Sofie T Halvorsen, MA Music Therapy
  • 전화번호: +4407907361997
  • 이메일: nth108@prg.aru.ac.uk

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Parent-child relational co-regulation and interaction
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Parental sense of competence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2026년 6월 8일

QC 기준을 충족하는 최초 제출

2026년 6월 25일

처음 게시됨 (실제)

2026년 7월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 25일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • ETH2526-2528

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

음악 치료에 대한 임상 시험

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