Premature BirthNCT06844396
The Impact of NICU Music Therapy for Preterm Infants and Caregivers
A study testing Music Therapy in people with Premature Birth, run by Anglia Ruskin University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- Primary caregiver(s) of an infant participating in the study
- Ability to complete questionnaires in English
- NICU Staff
- 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
Who cannot join
- Infants who are medically unstable
- Infants younger than 28 weeks CGA
- Severe hearing impairment or hearing loss
- Primary Caregivers:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Music Therapy
- Keywords
- NICU, Parent Mental Health, Music Therapy, Neonatal
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Music Therapy consisting of four types of protocol:
- Music combined with skin to skin
- Developmental multimodal technique
- Infant directed singing
- Parent/caregiver therapeutic support
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Music Therapy delivered twice weekly to infants on a NICU ward Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Temperature
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
Measured: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Heart Rate
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
Measured: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Respiratory Rate
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
Measured: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Infant Oxygen Saturation
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
Measured: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally
Secondary outcomes (7)
Infant Calorie Intake
- Data relating to feeding behaviours will be recorded in caloric intake and reported in ml daily throughout the intervention period.
Measured: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Infant Weight
Data relating to weight gain in kg will be recorded daily throughout the intervention period
Measured: 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
- Data relating to sleeping patterns will be recorded in hours and reported daily throughout the intervention period.
Measured: 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
- Data relating to length of hospital stay will be recorded in days.
Measured: From enrollment to the end of the infant's treatment or at 6 weeks
Caregiver Postpartum Bonding Questionnaire
- 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.
Measured: 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
- 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.
Measured: 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
- 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.
Measured: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start12 May 2025
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Collaborators
- The Whittington Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan Pool, PhD, Principal investigator, Anglia Ruskin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844396
- Sponsor's protocol ID
- ETH2425-0374
- Status last verified
- Oct 2025
- First submitted
- 16 Jan 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of the sponsor organisation and will be kept securely within internal University secure sharing systems.
Publications
Walworth D, Standley J, Robertson A, Smith A, Swedberg O, Peyton JJ. (2012). Effects of neurodevelopmental stimulation on premature infants in neonatal intensive care: Randomized controlled trial. Journal of Neonatal Nursing, 18, 210-216.
Whipple, J. (2005). Music and multimodal stimulation as developmental interven- tion in neonatal intensive care. Music Therapy Perspectives, 23(2), 100-105.
Whipple J. The effect of parent training in music and multimodal stimulation on parent-neonate interactions in the neonatal intensive care unit. J Music Ther. 2000 Winter;37(4):250-68. doi: 10.1093/jmt/37.4.250.
PubMed 11281808Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
PubMed 22908052Standley JM, Cassidy J, Grant R, Cevasco A, Szuch C, Nguyen J, Walworth D, Procelli D, Jarred J, Adams K. The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. Pediatr Nurs. 2010 May-Jun;36(3):138-45.
PubMed 20687305Standley JM. The effect of music and multimodal stimulation on responses of premature infants in neonatal intensive care. Pediatr Nurs. 1998 Nov-Dec;24(6):532-8.
PubMed 10085995Standley, J.M. and Gutierrez, C., 2020. Benefits of a Comprehensive Evidence-Based NICU-MT Program: Family-Centered, Neurodevelopmental Music Therapy for Premature Infants. Pediatric Nursing, 46(1).
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
PubMed 1393159Jaschke, A.C. (2020), Muziektherapeutisch interventies 3.0 - How to hack the academy?, Special Issue, Tijdschrift voor Vaktherapie 16(4)
Ormston K, Howard R, Gallagher K, Mitra S, Jaschke A. The Role of Music Therapy with Infants with Perinatal Brain Injury. Brain Sci. 2022 Apr 29;12(5):578. doi: 10.3390/brainsci12050578.
PubMed 35624965Detmer, M.R. (2016b). The use of parental singing: Enhancing neurodevelopment in premature infants. Imagine, 7(1), 66- 69.
Cevasco-Trotter AM, Hamm EL, Yang X, Parton J. Multimodal Neurological Enhancement Intervention for Self-regulation in Premature Infants. Adv Neonatal Care. 2019 Aug;19(4):E3-E11. doi: 10.1097/ANC.0000000000000595.
PubMed 30946037Cevasco AM. The effects of mothers' singing on full-term and preterm infants and maternal emotional responses. J Music Ther. 2008 Fall;45(3):273-306. doi: 10.1093/jmt/45.3.273.
PubMed 18959452Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
PubMed 16673041
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of NICU Music Therapy on Preterm Infants' Clinical Markers and Caregiver Wellbeing
- ClinicalTrials.gov ID
- NCT06844396
- Acronym / sponsor ID
- ETH2425-0374
- Conditions
- Premature Birth
- Keywords
- NICU, Parent Mental Health, Music Therapy, Neonatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Collaborators
- The Whittington Hospital NHS Trust
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyMusic Therapy delivered twice weekly to infants on a NICU ward |
Who may qualify
- Ages
- 28 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Primary caregiver(s) of an infant participating in the study
- Ability to complete questionnaires in English
Key exclusion criteria (4 listed)
- Infants who are medically unstable
- Infants younger than 28 weeks CGA
- Severe hearing impairment or hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyMusic Therapy consisting of four types of protocol: * Music combined with skin to skin * Developmental multimodal technique * Infant directed singing * Parent/caregiver therapeutic support | Other | Music Therapy |
Primary outcome
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
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
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
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
7 secondary outcomes
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.
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.
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.
Infant Length of Hospital Stay
Time frame: 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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- BackgroundWalworth D, Standley J, Robertson A, Smith A, Swedberg O, Peyton JJ. (2012). Effects of neurodevelopmental stimulation on premature infants in neonatal intensive care: Randomized controlled trial. Journal of Neonatal Nursing, 18, 210-216.
- BackgroundWhipple, J. (2005). Music and multimodal stimulation as developmental interven- tion in neonatal intensive care. Music Therapy Perspectives, 23(2), 100-105.
- Background: PubMed 11281808Whipple J. The effect of parent training in music and multimodal stimulation on parent-neonate interactions in the neonatal intensive care unit. J Music Ther. 2000 Winter;37(4):250-68. doi: 10.1093/jmt/37.4.250.
- Background: PubMed 22908052Standley J. Music therapy research in the NICU: an updated meta-analysis. Neonatal Netw. 2012 Sep-Oct;31(5):311-6. doi: 10.1891/0730-0832.31.5.311.
- Background: PubMed 20687305Standley JM, Cassidy J, Grant R, Cevasco A, Szuch C, Nguyen J, Walworth D, Procelli D, Jarred J, Adams K. The effect of music reinforcement for non-nutritive sucking on nipple feeding of premature infants. Pediatr Nurs. 2010 May-Jun;36(3):138-45.
- Background: PubMed 10085995Standley JM. The effect of music and multimodal stimulation on responses of premature infants in neonatal intensive care. Pediatr Nurs. 1998 Nov-Dec;24(6):532-8.
- BackgroundStandley, J.M. and Gutierrez, C., 2020. Benefits of a Comprehensive Evidence-Based NICU-MT Program: Family-Centered, Neurodevelopmental Music Therapy for Premature Infants. Pediatric Nursing, 46(1).
- Background: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Background: PubMed 1393159Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- BackgroundJaschke, A.C. (2020), Muziektherapeutisch interventies 3.0 - How to hack the academy?, Special Issue, Tijdschrift voor Vaktherapie 16(4)
- Background: PubMed 35624965Ormston K, Howard R, Gallagher K, Mitra S, Jaschke A. The Role of Music Therapy with Infants with Perinatal Brain Injury. Brain Sci. 2022 Apr 29;12(5):578. doi: 10.3390/brainsci12050578.
- BackgroundDetmer, M.R. (2016b). The use of parental singing: Enhancing neurodevelopment in premature infants. Imagine, 7(1), 66- 69.
- Individual participant dataSharing planned: No. IPD will not be shared outside of the sponsor organisation and will be kept securely within internal University secure sharing systems.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Pool, PhD principal investigator
Anglia Ruskin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Premature Birth, run by Anglia Ruskin University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Temperature (time frame: Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06844396, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.