The Impact of NICU Music Therapy for Preterm Infants and Caregivers

January 29, 2026 updated by: Anglia Ruskin University

The Impact of NICU Music Therapy on Preterm Infants' Clinical Markers and Caregiver Wellbeing

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy
Music Therapy delivered twice weekly to infants on a NICU ward
Other: Music Therapy

Music Therapy consisting of four types of protocol:

  • Music combined with skin to skin
  • Developmental multimodal technique
  • Infant directed singing
  • Parent/caregiver therapeutic support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Temperature
Time Frame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Routinely collected clinical data will be collected for each infant participant to include temperature reported at degrees celcius. The data is collected using Nellcor/Covidien monitors
Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Heart Rate
Time Frame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Routinely collected clinical data will be collected for each infant participant to include heart rate reported in beats per minute. The data is collected using Nellcor/Covidien monitors
Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Respiratory Rate
Time Frame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Routinely collected clinical data will be collected for each infant participant to include respiratory rate reported in breaths per minute. The data is collected using Nellcor/Covidien monitors
Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Oxygen Saturation
Time Frame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Routinely collected clinical data will be collected for each infant participant to include oxygen saturation reported by percentage. The data is collected using Nellcor/Covidien monitors
Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Calorie Intake
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
• Data relating to feeding behaviours will be recorded in caloric intake and reported in ml daily throughout the intervention period.
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Infant Weight
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Data relating to weight gain in kg will be recorded daily throughout the intervention period
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Infant Sleep Record
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
• Data relating to sleeping patterns will be recorded in hours and reported daily throughout the intervention period.
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Infant Length of Hospital Stay
Time Frame: From enrollment to the end of the infant's treatment or at 6 weeks
• Data relating to length of hospital stay will be recorded in days.
From enrollment to the end of the infant's treatment or at 6 weeks
Caregiver Postpartum Bonding Questionnaire
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
• To assess bonding and emotional wellbeing, parents will be asked to complete the Postpartum Bonding Questionnaire (PBQ) immediately before the first intervention and immediately after the last intervention. The PBQ has 25 statements, each followed by six alternative responses ranging from 'always' to 'never'. Positive responses, such as ''I enjoy playing with my baby'', are scored from zero ('always') to 5 ('never'). Negative responses, such as ''I am afraid of my baby'', are scored from 5 ('always') to zero ('never'). The scores are summated for each factor, a high score indicating pathology.
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Caregiver Perceived Stress Scale-NICU
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
• To assess bonding and emotional wellbeing, parents will be asked to complete the Perceived Stress Scale-NICU (PSS-NICU) immediately before the first intervention and immediately after the last intervention. The PSS-NICU asks the parent to rate a variety of sights and sounds, their baby's looks and behaviour, their parental role and relationship with the baby, and staff behaviour and communication on a scale of N/A, not at all stressful, a little stressful, moderately stressful, very stressful and extremely stressful. The higher the score, the more stressed a parent is feeling.
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Caregiver State-Trait Anxiety Inventory
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
• To assess bonding and emotional wellbeing, parents will be asked to complete the State-Trait Anxiety Inventory (STAI-6) immediately before the first intervention and immediately after the last intervention. The questionnaire asks respondents to select the most appropriate response to 20 statements relating to anxiety: 1 (not at all) 2 (a little) 3 (somewhat) or 4 (very much so). Some questions are reverse coded and therefore some questions indicate anxiety if they are given a high score, whereas reverse coded questions indicate anxiety if they are given a low score.
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of NICU Music Therapy
Time Frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.

Participating caregivers and NICU staff will be invited to complete a questionnaire about their experiences with music therapy on the NICU. The questionnaire comprises of statements and open questions to gather quantitative and qualitative information. The questions are as follows:

What do you think about having music therapy on the ward? (options given) To what extent did music therapy affect infant responses? (options given) How would you rate your responses to music therapy on the ward? (options given) What benefits do you think could result from having music therapy on the ward? (open question) What challenges do you think could result from having music therapy on the ward? (open question) Would you recommend music therapy to other parents or carers on the ward during their stay? (options given)
Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Music Therapy Intervention Fidelity
Time Frame: Weeks 1 - 6 of the study period.
The music therapist will utilise a fidelity checklist to monitor which music interventions were used and the extent to which the music therapy sessions adhered to or deviated from interventions outlined in the protocol, namely the four music therapy protocols drawn from the NICU-MT method. The fidelity checklist requires the therapist to record the following information for each music therapy session they provide for each infant participating in the study: Eligibility Checklist complete? (Y/N) Parent/ Carer Consent? (Y/N) MT Interventions Used (i.e. skin to skin, multimodal, singing, parent therapeutic support Resources and Equipment Length of session Time/Date Caregiver/s involved? Y/N Infant Responses (i.e. regulation, tolerance, sleep) Caregiver Responses (i.e. Mood, wellbeing state or caregiver/infant interaction Other Notes (deviations from protocol, interruptions or medical interventions at the same time, explaining changes in infant and why?)
Weeks 1 - 6 of the study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglia Ruskin University

Collaborators

The Whittington Hospital NHS Trust

Investigators

  • Principal Investigator: Jonathan Pool, PhD, Anglia Ruskin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETH2425-0374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared outside of the sponsor organisation and will be kept securely within internal University secure sharing systems.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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