Whittington NHS Health Trust
London, United Kingdom
NCT Number: NCT06844396
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.
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Notify Me28 week and older
All sexes
Interventional
Not applicable
London, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Infant Participants:
Inclusion criteria
Exclusion criteria
Primary Caregivers:
Inclusion criteria
NICU Staff
Inclusion criteria
Music Therapy consisting of four types of protocol:
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
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
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
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
Time frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
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
Time frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Time frame: From enrollment to the end of the infant's treatment or at 6 weeks
Time frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Time frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
Time frame: Weeks 1 - 6 of the study period, or as long as the infant is admitted to NICU during the 6 week period.
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)
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?)
Anglia Ruskin University
Other
The Impact of NICU Music Therapy on Preterm Infants' Clinical Markers and Caregiver Wellbeing
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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