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Music therapy during skin-breaking procedures in infants admitted to a Neonatal Intensive Care Unit or High Care ward: a non-pharmacological intervention

Music therapy during skin-breaking procedures in infants admitted to a Neonatal Intensive Care Unit or High Care ward: a non-pharmacological intervention - Music therapy during skin-breaking procedures

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56924
Enrollment
2
Registered
2024-02-07
Start date
2025-04-09
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and stress Pain and stress

Interventions

The intervention will be a sedative live-performed music therapy session according to the Rhythm, Breath and Lullaby method. This protocol is currently standard care in several centers, including th

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates admitted to a NICU or a HC ward: - If the gestational age is between 33 and 42 weeks, expected length of stay >2 weeks - If the gestational age is 3 weeks (because one of our research projects has shown that starting music therapy after 7 days is more beneficial for these children than starting before 7 days of life) - Need for repeated skin-breaking procedures (at least three) within the study period - Written informed consent from parents

Exclusion criteria

Exclusion criteria: - Inability of the parents to understand/speak Dutch

Design outcomes

Primary

MeasureTime frame
Our primary outcome is the direct pain response, measured using the Preterm Infant Pain Profile - Revised (PIPP-R).

Secondary

MeasureTime frame
Secondary outcomes will be heart rate variability (HRV), cerebral oxygen saturation using near-infrared spectroscopy (NIRS), changes in cortical activity measured using amplitude-integrated EEG, General Movements Optimality Scores, and our in depth musical micro-analysis and parental/staff perspectives on music therapy as procedural support.

Countries

Netherlands

Contacts

Public ContactN.H. Dokkum

Universitair Medisch Centrum Groningen

n.h.van.dokkum@umcg.nl0503614215

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026