The objectives of the study are to:A. Determine the effects of music therapy during skin-breaking procedures on the pain response in infants admitted to a NICU or HC ward.B. Determine the effects of music therapy during skin-breaking procedures on…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome is the direct pain response, measured using the Preterm
Infant Pain Profile - Revised (PIPP-R).
Secondary outcome
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.
Background summary
Neonates admitted to a Neonatal Intensive Care Unit (NICU) or a high care (HC)
ward experience a highly different environment compared with the maternal womb.
Although this environment is lifesaving, it involves a variety of stressors,
such as painful procedures that may have long-lasting consequences after
discharge. Mechanisms through which these long-term consequences occur are
proposed to be altered hypothalamic-pituitary-adrenal (HPA) axis development,
responsible for the stress regulation in the body through cortisol production,
and a direct effect on brain development. While pharmacological analgesia has
been implemented, non-pharmacological options have also been suggested to
reduce pain, among which music therapy. Specifically in a NICU and HC setting,
music therapy is a promising and novel intervention that may counteract or
attenuate the altered stress response through creating a possible link to
in-utero exposure to musical sounds (i.e., rhythmic heartbeat, maternal voice,
or music listened to by the mother). Music therapy regards the use of
live-performed musical interventions by a certified neonatal music therapist,
and it is tailored to the needs of the individual infant and their parents.
With our study, we aim to investigate the effects of music therapy during
skin-breaking procedures in neonates admitted to a NICU or HC ward on the pain
and stress response.
Study objective
The objectives of the study are to:
A. Determine the effects of music therapy during skin-breaking procedures on
the pain response in infants admitted to a NICU or HC ward.
B. Determine the effects of music therapy during skin-breaking procedures on
the autonomic nervous system regulation in infants admitted to a NICU or HC
ward.
C. Further clarify the mechanism of music therapy in regulating pain response
and autonomic nervous system response by performing a micro-analysis of the
music played in concordance with responses by infants.
D. To evaluate parental perspectives on music therapy during skin-breaking
procedures.
Study design
A randomized controlled cross-over study including 75 infants.
Intervention
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 the NICU of the UMCG, but at
present not used for procedural support. The UMCG NICU employs two
board-certified music therapists with the additional Rhythm, Breath and Lullaby
specialization. The intervention will commence before the painful procedure and
will be continued after the painful procedure is finished, to cover the full
procedure.
Study burden and risks
Data for this study cannot be obtained in another population, as the intention
is to study the live-music for procedural support in infants. As this
intervention may be pain relieving, stress reducing and improving
neurodevelopment, it is worthwhile to study. We believe that the burden and
risks associated with the participation in this pilot study are small to
non-existent.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86317.042.24 |