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Comparing efficacy of music therapy, sucrose and combination of the two for pain relief in neonates undergoing heel prick procedure.

Comparing efficacy of music therapy, sucrose and combination of the two in neonates for pain relief during heel prick procedure.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000271505
Acronym
Music therapy for Neonates
Enrollment
35
Registered
2015-03-23
Start date
2015-07-07
Completion date
2016-01-22
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Does the use of Music Therapy or Combination of music therapy with sucrose (24 % sterile sugar water) provide similar or better pain relief compared to Sucrose during the heel prick procedure. The research is aimmed to see if we can reduce the usage of sucrose, especially repeated and higher dosages in NICU with the help of music therapy which is relatively safe (within the recommened sound dose levels) and developementally appropriate intervention.

Interventions

Study neonate undergoing heel prick procedure for blood collection will get in random order - Oral sucrose (Sterile 24%), Music therapy and combination of the above two methods in addition to standrad practice of swaddling and oral pacifier. Intervention I (MT) - Music therapy Intervention II (S) - Oral sucrose (24 %) with no music Intervention III (MT+S) - Oral sucrose (24 %) with music therapy MT group - In MT group the neonate will be exposed to Passive music therapy with instrumental

Study neonate undergoing heel prick procedure for blood collection will get in random order - Oral sucrose (Sterile 24%), Music therapy and combination of the above two methods in addition to standrad practice of swaddling and oral pacifier. Intervention I (MT) - Music therapy Intervention II (S) - Oral sucrose (24 %) with no music Intervention III (MT+S) - Oral sucrose (24 %) with music therapy MT group - In MT group the neonate will be exposed to Passive music therapy with instrumental lullabies with sounds up to 65 dB starting 20 minutes before the heel prick, continuing for 6 minutes after the painful procedure. S group – In S group the neonates will have no music. He/she will have oral sucrose (24 % sterile solution) 0.5 ml, two minutes prior to the beginning of the heel prick as per the current hospital protocol. MT+S group - In MT+S group the neonate will be exposed to Passive music therapy with instrumental lullabies with sounds up to 65 dB starting 20 minutes before the heel prick, continuing for 6 minutes after the painful procedure. In addition he/she will then have oral sucrose (24 % sterile solution) 0.5 ml, two minutes prior to the beginning of the heel prick as per the current hospital protocol. This is a crossover study with each neonate getting all three interventions in random order. There will be a minimum of 40 minutes of 'wash-out' period between subsequent interventions.

Sponsors

Royal North Shore Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to 28 Days
Healthy volunteers
No

Inclusion criteria

1. Newborns >/= 32 weeks 2. Stable clinical condition with no need of CPAP/high flow/Ventilation 3. Anticipated need for repeated heel prick samples for monitoring and blood collection

Exclusion criteria

1. Presence of major congenital abnormality 2. Presence of proven or suspected sepsis 3. Suspicion or confirmed NEC 4. Need of CPAP/high flow/Ventilation in last 24 hrs. 5. Major IVH, history of seizures, HIE, neonatal encephalopathy 6. Hypoglycaemia with BSL < 1.5 mmol/L

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 8, 2026