The Impact of NICU Music Therapy for Preterm Infants and Caregivers

NCT06844396 | Completed

• 1 other identifier: ETH2425-0374
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

NICU; Parent Mental Health; Music Therapy; Neonatal

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Baseline (resting state), within 15 minutes pre-intervention, during the intervention, within 15 minutes post-intervention, and periprocedurally

Secondary Outcomes (7)

• Infant Calorie Intake

  Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.

• Infant Weight

  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

  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

  From enrollment to the end of the infant's treatment or at 6 weeks

• Caregiver Postpartum Bonding Questionnaire

  Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.

Other Outcomes (2)

• Acceptability of NICU Music Therapy

  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

  Weeks 1 - 6 of the study period.

Study Arms (1)

Music Therapy

EXPERIMENTAL

Music Therapy delivered twice weekly to infants on a NICU ward

Other: Music Therapy

Interventions

Music Therapy OTHER

Music Therapy consisting of four types of protocol: * Music combined with skin to skin * Developmental multimodal technique * Infant directed singing * Parent/caregiver therapeutic support

Music Therapy

Eligibility Criteria

• Age: 28 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infants who are medically unstable
• Infants younger than 28 weeks CGA
• Severe hearing impairment or hearing loss
• Primary Caregivers:
• Primary caregiver(s) of an infant participating in the study
• Ability to complete questionnaires in English
• NICU Staff
• 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

Sponsors & Collaborators

• Anglia Ruskin University: lead
• The Whittington Hospital NHS Trust: collaborator

Study Sites (1)

Whittington NHS Health Trust

London, United Kingdom

Location

Related Publications (21)

• 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.

  BACKGROUND

• Whipple, J. (2005). Music and multimodal stimulation as developmental interven- tion in neonatal intensive care. Music Therapy Perspectives, 23(2), 100-105.

  BACKGROUND

• 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.

  PMID: 11281808 BACKGROUND

• Standley 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.

  PMID: 22908052 BACKGROUND

• Standley 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.

  PMID: 20687305 BACKGROUND

• Standley 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.

  PMID: 10085995 BACKGROUND

• Standley, 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

• Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

  PMID: 8506163 BACKGROUND

• Marteau 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.

  PMID: 1393159 BACKGROUND

• Jaschke, A.C. (2020), Muziektherapeutisch interventies 3.0 - How to hack the academy?, Special Issue, Tijdschrift voor Vaktherapie 16(4)

  BACKGROUND

• 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.

  PMID: 35624965 BACKGROUND

• Detmer, M.R. (2016b). The use of parental singing: Enhancing neurodevelopment in premature infants. Imagine, 7(1), 66- 69.

  BACKGROUND

• 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.

  PMID: 30946037 BACKGROUND

• Cevasco 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.

  PMID: 18959452 BACKGROUND

• Brockington 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.

  PMID: 16673041 BACKGROUND

• van Dokkum, N.H., Kooi. E.M.W., Berhane, B., Ravensbergen, A.G., Hakvoort, L., Jaschke, A.C. & Bos, A.F., (2021), Neonatal music therapy and cerebral oxygenation in extremely and very preterm infants: a pilot study, Special Issue 13(2): Music Therapy in the Neonatal Intensive Care Unit

  BACKGROUND

• van Dokkum NH, Jaschke AC, Ravensbergen AG, Reijneveld SA, Hakvoort L, de Kroon MLA, Bos AF. Feasibility of Live-Performed Music Therapy for Extremely and Very Preterm Infants in a Tertiary NICU. Front Pediatr. 2020 Oct 16;8:581372. doi: 10.3389/fped.2020.581372. eCollection 2020.

  PMID: 33178653 BACKGROUND

• Anderson DE, Patel AD. Infants born preterm, stress, and neurodevelopment in the neonatal intensive care unit: might music have an impact? Dev Med Child Neurol. 2018 Mar;60(3):256-266. doi: 10.1111/dmcn.13663. Epub 2018 Jan 24.

  PMID: 29363098 BACKGROUND

• Span LC, van Dokkum NH, Ravensbergen AG, Bos AF, Jaschke AC. Combining Kangaroo Care and Live-Performed Music Therapy: Effects on Physiological Stability and Neurological Functioning in Extremely and Very Preterm Infants. Int J Environ Res Public Health. 2021 Jun 18;18(12):6580. doi: 10.3390/ijerph18126580.

  PMID: 34207310 BACKGROUND

• Kraft KE, Jaschke AC, Ravensbergen AG, Feenstra-Weelink A, van Goor MEL, de Kroon MLA, Reijneveld SA, Bos AF, van Dokkum NH. Maternal Anxiety, Infant Stress, and the Role of Live-Performed Music Therapy during NICU Stay in The Netherlands. Int J Environ Res Public Health. 2021 Jul 2;18(13):7077. doi: 10.3390/ijerph18137077.

  PMID: 34281014 BACKGROUND

• Bos M, van Dokkum NH, Ravensbergen AG, Kraft KE, Bos AF, Jaschke AC. Pilot study finds that performing live music therapy in intensive care units may be beneficial for infants' neurodevelopment. Acta Paediatr. 2021 Aug;110(8):2350-2351. doi: 10.1111/apa.15867. Epub 2021 May 2. No abstract available.

  PMID: 33811376 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jonathan Pool, PhD

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 25, 2025
• Study Start: May 12, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)