Clinical trial NCT06844396: The Impact of NICU Music Therapy for Preterm Infants and Caregivers
Official title: The Impact of NICU Music Therapy on Preterm Infants' Clinical Markers and Caregiver Wellbeing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: NICU
Parent Mental Health
Music Therapy
Neonatal
Lead sponsor: Anglia Ruskin University
Sponsor class: OTHER
Collaborators: name: The Whittington Hospital NHS Trust
First posted: 2025-02-25
Enrollment: 28
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to provide initial evidence for the use of music therapy in the NICU in a UK context. In other countries, such as the US and the Netherlands, music therapy is routinely provided in the NICU and research has demonstrated benefits for the both the child and their caregivers. As there is no existing UK-based research on music therapy in the NICU, medical institutions are reluctant to consider the benefits of music therapy. This reduces infants' access to non-invasive treatment in the NICU. Our study aims to address this gap.

Detailed description: The aim of this pilot study is to investigate the impact of Neonatal Intensive Care Unit (NICU) Music Therapy (MT) interventions on preterm infants' clinical markers and caregiver wellbeing. The study will investigate changes in the participating infants' clinical markers (heart rate, oxygen saturation, blood pressure, respiration rate) before, during and after therapy, weight gain, feeding behaviours, sleep patterns, discharge time and caregiver wellbeing, including bonding and mood. The study also aims to assess the acceptability of music therapy for pre-term infants, caregivers and NICU staff, and explore how music therapy can be used on NICU wards in the UK.

NICU care, while lifesaving, has been shown to have negative long-term consequences, which can include repeated activation of the stress response and reduced maternal interaction, with possible negative long-term impacts on brain development.

The NHS published an action plan to implement recommendations for improving neonatal care. The report does not specify music therapy. However, initial research in the US, Switzerland, and the Netherlands has shown clinically and statistically significant improvements on well-being, stress reduction and neural development in the neonate. Beyond these crucial findings, music therapy had a positive effect on parent well-being, parent-child interaction and the overall reduction of noise levels on the ward.

This pilot study will consist of a six-week data collection period. During this time, infants and their primary caregiver(s) will be invited to participate in the study on admission to the NICU.

Participants will be offered music therapy sessions twice weekly over the course of the six-week data collection period. The music therapist will determine the appropriate music therapy interventions according to the infant's needs, therapeutic goals and corrected gestational age. These could include one of the four interventions from the NICU-MT method depending on therapeutic need, 1) music combined with caregiver skin to skin, 2) developmental multimodal technique, 3) infant directed singing and 4) caregiver therapeutic support. The caregiver may also be involved in the session during the use of multimodal technique, infant directed singing, and caregiver skin to skin. Sessions will last approximately 30 minutes, with 10 - 20 minutes of music.

NICU staff working on the ward during the study and caregivers will also be invited to participate in the evaluation of the acceptability of the music therapy intervention.

The quantitative data from infants participating in this study will comprise of routine data gathered for clinical purposes. The investigators will use data gathered at the time of the music therapy intervention and during a control time (no intervention) to measure the impact of the intervention on clinical markers. Data routinely collected at the High Dependency Unit (HDU) includes hourly recording on an observation sheet of temperature, heart rate, respiratory rate and oxygen saturations using Nellcor/Covidien monitors.

The study will also gather data relating to feeding behaviours, weight gain, length of stay and sleep patterns as well as follow up data relating to developmental milestones.

To assess bonding and emotional wellbeing, parents will be asked to complete three questionnaires before the first music therapy session and after the last music therapy session.

To investigate how music therapy is used with pre-term infants and their families in the NICU, the music therapist will keep a log of music therapy interventions used, including clinical notes relating to infant and family responses during the session. They will also complete a fidelity checklist after each session, for the purposes of monitoring adherence to the interventions outlined in the protocol.

Ultimately, this pilot study will inform and support further research in this area focusing on longer-term outcomes for NICU infants. As there is no UK-based evidence for the use of NICU-MT on wards in the UK, medical institutions are unwilling to consider the benefits of music therapy as standard for infant care. This sets the UK far behind other countries in terms of non-invasive treatments for this population.

Eligibility criteria: Infant Participants:

Inclusion Criteria:

* Infants in or admitted to the Whittington NHS Trust NICU High Dependency Unit (HDU) during the 6-week intervention and data collection period
* Infants are medically stable
* Infants at 28 weeks corrected gestational age and above

Exclusion Criteria:

* Infants who are medically unstable
* Infants younger than 28 weeks CGA
* Severe hearing impairment or hearing loss

Primary Caregivers:

Inclusion criteria:

* Primary caregiver(s) of an infant participating in the study
* Ability to complete questionnaires in English

NICU Staff

Inclusion criteria:

* 1 month experience working at the Whittington NHS Trust NICU
* At least two days' experience working on music therapy service provision days during the intervention period

Primary outcomes:
measure: Infant Temperature
timeFrame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
measure: Infant Heart Rate
timeFrame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
measure: Infant Respiratory Rate
timeFrame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
measure: Infant Oxygen Saturation
timeFrame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Secondary outcomes:
measure: Infant Calorie Intake
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Infant Weight
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Infant Sleep Record
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Infant Length of Hospital Stay
timeFrame: From enrollment to the end of the infant's treatment or at 6 weeks
measure: Caregiver Postpartum Bonding Questionnaire
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Caregiver Perceived Stress Scale-NICU
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Caregiver State-Trait Anxiety Inventory
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Other outcomes:
measure: Acceptability of NICU Music Therapy
timeFrame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
measure: Music Therapy Intervention Fidelity
timeFrame: Weeks 1 - 6 of the study period.
Locations:
Study officials:
affiliation: Anglia Ruskin University
name: Jonathan Pool, PhD
role: PRINCIPAL_INVESTIGATOR
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