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Effectiveness of White Noise on Pain in Neonates During Invasive Procedures: A Randomized Controlled Trial

Effectiveness of White Noise on Pain in Neonates During Invasive Procedures: A Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260122012
Enrollment
72
Registered
2026-01-22
Start date
2025-11-02
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Neonates in neonatal intensive care units (NICUs) undergo numerous painful procedures, such as heel pricks, arterial or venous blood draws, and intravenous or intramuscular injections, as part of routine medical care. These repeated untreated painful and stressful stimuli have been demonstrated to disrupt infant neural synaptogenesis, brain maturation, and development. Several studies showed that positive effects of white noise interventions in neonates, including pain reduction, improved sleep

Interventions

Neonates in the Intervention group were exposed to 50 dB white noise from the album (Colic Baby: White Noise for Babies) using the episode (Calm Rain for Colic Baby Sleep) which consists of only intra
Experimental No treatment
White noise

Sponsors

Phenikaa University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 28 Days

Inclusion criteria

Inclusion criteria: (1) performing invasive interventions (heel prick blood sampling, blood sampling for testing, intravenous injection/infusion); (2) gestational age from 37 - 42 weeks.

Exclusion criteria

Exclusion criteria: (1) newborns who are in a condition that affects their physiological response to pain, such as congenital malformations; post-surgery; use of sedatives, muscle relaxants, or anticonvulsants; (2) any condition that affects the child's hearing (e.g., congenital deafness); (3) are receiving oxygen; (4) have an axillary temperature above 37.5 degree Celcius . During the intervention, if the child has additional indications for oxygen therapy or develops a fever, consider excluding them from the study.

Design outcomes

Primary

MeasureTime frame
Pain score After intervention Neonatal Infant Pain Scale

Secondary

MeasureTime frame
Spo2 Baseline; After intervention Using device

Countries

Vietnam

Contacts

Public ContactPham Truong

Phenikaa University Hospital

Truongpham9@gmail.com0967255816

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026