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Supportive Outcomes Of Therapeutic Heartbeat exposure-Neonates: (SOOTHE-Neo). A randomised Controlled Trial

Supportive Outcomes Of Therapeutic Heartbeat exposure-Neonates: (SOOTHE-Neo). A randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000846325
Acronym
SOOTHE-Neo
Enrollment
66
Registered
2026-07-13
Start date
2026-09-11
Completion date
2027-02-28
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates whether playing recorded maternal heartbeat sounds to babies after surgery can improve their recovery. The researchers hypothesise that this familiar, soothing sound will reduce pain, improve physiological stability (such as heart rate, breathing, and oxygen levels), and decrease the need for pain medications. The main outcome will be differences in pain scores over the first 48 hours after surgery, while secondary outcomes include cardiorespiratory stability, analgesic use, stress hormone levels, and parent satisfaction. Overall, the study aims to test a simple, low-risk intervention that could enhance comfort and recovery for vulnerable newborns.

Interventions

What is the intervention: A recording of the baby's maternal heartbeat (utilising a digital recording stethoscope) placed near the infant and played on a continuous loop for 48 hours after infant returns to the neonatal unit following surgery. The sound level will be carefully checked to ensure it remains within safe limits for newborns (45-50 dB) using the calibrated sound meter and will not interfere with normal care or monitoring. This sound level will be check once per shift and noted on th

What is the intervention: A recording of the baby's maternal heartbeat (utilising a digital recording stethoscope) placed near the infant and played on a continuous loop for 48 hours after infant returns to the neonatal unit following surgery. The sound level will be carefully checked to ensure it remains within safe limits for newborns (45-50 dB) using the calibrated sound meter and will not interfere with normal care or monitoring. This sound level will be check once per shift and noted on the bedside observation chart. All other aspects of the infants care, including analgesia will continue the same regime as is per usual post-operative analgesic management. There is no current guideline or standardisation for neonatal post-operative pain relief and clinical management of analgesia is dependent on Neonatologist/treating medical team on service. Titration and weaning of analgesia is completed following review/discussion with Medical Officer (MO)/ Neonatal Nurse Practitioner (NNP). Pain scores, using the Pain Assessment Tool( PAT) are used to help guide the decision to titrate analgesia weaning.

Sponsors

Mater Mothers' Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
32 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

Infants > 32weeks requiring surgery (eligible to use the PAT score) Parents/guardians able provide written informed consent.

Exclusion criteria

Infants requiring emergency surgery within 30mins

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026