White noise for procedural comfort: A randomized controlled trial on pain reduction by using white noise during blood sampling and intravenous cannulation in neonates

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260427007

Enrollment

216

Registered

2026-04-27

Start date

2026-04-27

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

Procedural pain in neonates undergoing blood sampling and intravenous cannulation White noise, 24% sucrose, Premature Infant Pain Profile-Revised (PIPP-R), Blood sampling, Intravenous cannulation, Non-pharmacological pain management

Interventions

-Standard care (receiving a pacifier and swaddling) with interventions applied 7 minutes before procedures -No white noise and 24% sucrose,-Standard care (receiving a pacifier and swaddling) with int

No Intervention No treatment,Experimental Drug,Experimental Device,Experimental Device

WNN,WNN-S,WNP,WNP-S

Eligibility

Sex/Gender

All

Age

34 Weeks to 44 Weeks

Inclusion criteria

Inclusion criteria: 1. Preterm neonates 34 to 36 weeks (PMA not more than 44 weeks) 2. Term neonates until 37 weeks aged 0 to 28 days, admitted to neonatal or obstetric wards, requiring blood sampling or intravenous cannulation, and with a history of not more than 5 prior needle-related procedures (e.g., blood sampling, IV access, lumbar puncture, or fluid or air drainage).

Exclusion criteria

Exclusion criteria: 1. Maternal history of stimulant drug use or caffeine consumption within 48 h prior to delivery 2. Congenital anomalies 3. Moderate to severe HIE requiring therapeutic hypothermia 4. Requiring an invasive ventilator or CPAP 5. Receiving CNS stimulants or analgesic agents until 48 h prior to blood sampling or IV-line insertion 6. Abnormal hearing screening (OAE or AABR) results 7. Parents refuse to participate

Design outcomes

Primary

Measure	Time frame
Premature Infant Pain Profile-Revised During, immediately after and 5 minutes post-procedure A blinded neonatologist using video-based PIPP-R pain scores during, immediately after and 5 minutes post-procedure	—

Secondary

Measure	Time frame
Vital signs (heart rate, respiratory rate, and oxygen saturation) During, immediate minutes post-procedure Use pulse oximeter and nurse	—

Countries

Thailand

Contacts

Public ContactSupreeya Padungsak

Faculty of Medicine Ramathibodi Hospital, Mahidol University

supreeya.padungsak@gmail.com022011816

Outcome results

None listed

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