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The effect of white noise on the withdrawal syndrome symptoms in infants born to substance-using mothers

The effect of white noise on the withdrawal syndrome symptoms in infants born to substance-using mothers

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250708066413N1
Enrollment
72
Registered
2025-07-14
Start date
2025-07-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

neonatal whithdrawal syndrome. reactions and intoxications from maternal opiates and tranquillizers administered during labor and delivery

Interventions

Intervention 1: Intervention group: Selected white noise from the Baby Sleep: White Noise application is played through a standard speaker placed at the center and top of the incubator, aligned with t

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Months to 28 Days

Inclusion criteria

Inclusion criteria: Diagnosis of withdrawal syndrome confirmed by a pediatric or neonatology specialist Gestational age = 34 weeks Birth weight = 1.5 kg 5-minute Apgar score > 6 No hearing impairment detected in the hearing screening No severe underlying medical conditions in the neonate Informed consent form signed by parents, if present No need for respiratory support or other invasive interventions for the treatment of other conditions No administration of sedative medications Within the first 48 hours of treatment No invasive procedures performed within two hours prior to the intervention or control

Exclusion criteria

Exclusion criteria: Development of a condition in the neonate requiring medical treatment Need for respiratory support Conditions requiring administration of sedative medications Clinical instability, such as oxygen saturation (SpO2) drop, bradycardia, tachycardia, or apnea Neonatal death Transfer or referral of the neonate to another facility Parents' unwillingness to continue the neonate's participation in the study

Design outcomes

Primary

MeasureTime frame
Finnegan score. Timepoint: 10 minutes before and after the interventin. Method of measurement: modified finnegan neonatal abstinence score sheet.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonir Ramezani

Mashhad University of Medical Sciences

RamezaniMN@mums.ac.ir+98 51 3882 9278

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026