Relational Music Therapy Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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:
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nina-Sofie T Halvorsen, MA Music Therapy
- Telefonní číslo: +4407907361997
- E-mail: nth108@prg.aru.ac.uk
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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:
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Parent-child relational co-regulation and interaction
Časové okno: 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:
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Parental sense of competence
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
- Feldman R. Parent-infant synchrony and the construction of shared timing; physiological precursors, developmental outcomes, and risk conditions. J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):329-54. doi: 10.1111/j.1469-7610.2006.01701.x.
- Gjems, S., & Diseth, T. H. (2011). Forebygging og behandling av psykologiske traumer hos somatisk syke barn. Tidsskrift for Norsk psykologforening (trykt utg.), 48(9).
- Silberstein, A. K., Ligård, E., Edlund, S. M., & Ullsten, A. (2024). Family-centered Music Therapy as Procedural Support in the Pediatric Outpatient Unit: A Mixed Methods Pilot Study. Music & Science, 7, 20592043231225734. https://doi.org/10.1177/20592043231225734
- Brown EA, De Young A, Kimble R, Kenardy J. Impact of Parental Acute Psychological Distress on Young Child Pain-Related Behavior Through Differences in Parenting Behavior During Pediatric Burn Wound Care. J Clin Psychol Med Settings. 2019 Dec;26(4):516-529. doi: 10.1007/s10880-018-9596-1.
- Kimball H, Cobham VE, Sanders M, Douglas T. Procedural anxiety among children and adolescents with cystic fibrosis and their parents. Pediatr Pulmonol. 2023 Jul;58(7):1967-1976. doi: 10.1002/ppul.26419. Epub 2023 Apr 25.
- Lakey B, Orehek E. Relational regulation theory: a new approach to explain the link between perceived social support and mental health. Psychol Rev. 2011 Jul;118(3):482-95. doi: 10.1037/a0023477.
- Robertson EG, Kelada L, Ilin R, Palmer EE, Bye A, Jaffe A, Kennedy SE, Ooi CY, Drew D, Wakefield CE. Psychological wellbeing among parents of a child living with a serious chronic illness: A cross-sectional survey study. J Child Health Care. 2025 Sep;29(3):626-641. doi: 10.1177/13674935241238485. Epub 2024 Mar 29.
- Wray J, Lee K, Dearmun N, Franck L. Parental anxiety and stress during children's hospitalisation: the StayClose study. J Child Health Care. 2011 Sep;15(3):163-74. doi: 10.1177/1367493511408632.
- Yinger OS. Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study. J Music Ther. 2016 Winter;53(4):336-363. doi: 10.1093/jmt/thw010. Epub 2016 Aug 17.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- ETH2526-2528
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .