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

25 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Nina-Sofie T Halvorsen, MA Music Therapy
  • Numero di telefono: +4407907361997
  • Email: nth108@prg.aru.ac.uk

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parent-child relational co-regulation and interaction
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Parental sense of competence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 gennaio 2027

Completamento dello studio (Stimato)

1 gennaio 2027

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • ETH2526-2528

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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