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

• Conditions: Pain; stress; 10028920

• Registration Number: NL-OMON56924
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 75

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 <32 weeks, expected length of stay > 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

- Inability of the parents to understand/speak Dutch

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary outcome is the direct pain response, measured using the Preterm<br /><br>Infant Pain Profile - Revised (PIPP-R). </p><br>

Secondary Outcome Measures

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