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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorAnglia Ruskin University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Music Therapy-Based Procedural Support (MTPS)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
From enrolment to the end of intervention period at 20 weeks

Secondary outcomes

1

Parental sense of competence

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.

Time frame
From enrolment until end of intervention period at 20 weeks
2

Child anxiety and procedural distress

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.

Time frame
From enrolment until end of intervention period at 20 weeks
3

Child emotional state

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.

Time frame
From enrolment until end of intervention period at 20 weeks
4

Child perception of relational support and co-regulation

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.

Time frame
From enrolment until end of intervention period at 20 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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