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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Behavioral Music Therapy-Based Procedural Support (MTPS)
  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

Primary outcome measures

• Parent-child relational co-regulation and interaction [Time frame: From enrolment to the end of intervention period at 20 weeks]

Secondary outcome measures (5)

• Parental sense of competence [Time frame: From enrolment until end of intervention period at 20 weeks]
• Child anxiety and procedural distress [Time frame: From enrolment until end of intervention period at 20 weeks]
• Child emotional state [Time frame: From enrolment until end of intervention period at 20 weeks]
• Child perception of relational support and co-regulation [Time frame: From enrolment until end of intervention period at 20 weeks]
• Child coping and adaptation [Time frame: From enrolment until end of intervention period at 20 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 30610521
• 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. PMID 17355401
• 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. PMID 36330583
• 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. PMID 37097054
• 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. PMID 21534704
• 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. PMID 38551845

Identifiers

NCT: NCT07680348 · ETH2526-2528

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗