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

NCT07680348 | Not Yet Recruiting

• 1 other identifier: ETH2526-2528
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Paediatric; Invasive Procedure; Relation, Family; Music Therapy; Procedural Fear

Outcome Measures

Primary Outcomes (1)

• Parent-child relational co-regulation and interaction

  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

Secondary Outcomes (5)

• Parental sense of competence

  From enrolment until end of intervention period at 20 weeks

• Child anxiety and procedural distress

  From enrolment until end of intervention period at 20 weeks

• Child emotional state

  From enrolment until end of intervention period at 20 weeks

• Child perception of relational support and co-regulation

  From enrolment until end of intervention period at 20 weeks

• Child coping and adaptation

  From enrolment until end of intervention period at 20 weeks

Study Arms (1)

Music Therapy-Based Procedural Support (MTPS)

EXPERIMENTAL

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.

Behavioral: Music Therapy-Based Procedural Support (MTPS)

Interventions

Music Therapy-Based Procedural Support (MTPS) BEHAVIORAL

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.

Music Therapy-Based Procedural Support (MTPS)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anglia Ruskin University: lead

Related Publications (10)

• Gjems, S., & Diseth, T. H. (2011). Forebygging og behandling av psykologiske traumer hos somatisk syke barn. Tidsskrift for Norsk psykologforening (trykt utg.), 48(9).

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21917594 BACKGROUND

• 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.

  PMID: 27535171 BACKGROUND

Central Study Contacts

Nina-Sofie T Halvorsen, MA Music Therapy

CONTACT

+4407907361997; nth108@prg.aru.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share