RecruitingNot ApplicableNCT07068581

Effect of Maternal Voice on Physiological Indicators and Feeding Performance

Effect of Maternal Voice on Physiological Indicators and Feeding Performance During Full Oral Feeding Transition in Preterm Infants: A Randomized Controlled Trial


Sponsor

Acibadem University

Enrollment

50 participants

Start Date

Aug 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aimed to determine the effect of maternal voice on physiological indicators and oral feeding performance in preterm infants. Hypothesis 1 (H1): Preterm infants who listen to their mother's voice throughout the full oral feeding process have higher oxygen saturation levels than those who do not. Hypothesis 2 (H2): Preterm infants who listen to their mother's voice throughout the full oral feeding process have lower heart rates than those who do not. Hypothesis 3 (H3): Preterm infants exposed to maternal voice throughout the full oral feeding process have lower respiratory rates than those who are not exposed. Hypothesis 4 (H4): Preterm infants exposed to maternal voice throughout the full oral feeding process have better feeding maturation than those who are not exposed. Hypothesis 5 (H5): The percentage of nutrient intake in preterm infants exposed to maternal voice throughout the entire oral feeding process is higher than in those not exposed. Hypothesis 6 (H6): The feeding time of preterm infants exposed to the mother's voice throughout the entire oral feeding process is shorter than that of those not exposed. Hypothesis 7 (H7): The amount of food consumed per minute by preterm infants exposed to the mother's voice throughout the entire oral feeding process is greater than that of those not exposed.


Eligibility

Min Age: 1 DayMax Age: 28 Days

Inclusion Criteria8

  • Preterm infants born at gestational age ≥28 weeks and ≤34 weeks
  • Infants who are ≥30 postmenstrual weeks old at the time of enrollment
  • Infants weighing ≥1000 grams at the time of enrollment
  • Mothers aged 18 years or older
  • Preterm infants who have passed the hearing screening test
  • Infants whose mothers can provide an average of at least 30 ml of expressed breast milk daily during the study period.
  • Mothers who are Turkish speakers.
  • Infants for whom the decision to transition from enteral feeding to full oral feeding has been made for the first time jointly by the physician and nurse

Exclusion Criteria5

  • Preterm infants with congenital anomalies.
  • Infants with a family history of congenital hearing loss.
  • Infants diagnosed with intraventricular hemorrhage (grade 3-4) or -periventricular leukomalacia.
  • Infants who have had necrotizing enterocolitis requiring treatment.
  • Infants whose mothers have a history of substance abuse or alcoholism

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREMaternal voice

Mothers of the infants in the intervention group will be asked to read aloud the lyrics of a designated in a calm tone of voice in a quiet environment, and their voices will be recorded. The recorded maternal voice will then be played to the infants in the NICU using the same Bluetooth-enabled device with built-in speakers. The audio device will be placed inside the incubator or open warmer, approximately 20-30 cm from the infant. Each infant will be assigned an individual audio device, which will be used exclusively for that infant. Maternal voice playback will begin 20 minutes before morning and evening oral feedings and will continue throughout the feeding session, twice daily, for a maximum of 5 days. If the infant is discharged earlier, the intervention will be discontinued.. During the playback of the maternal voice, monitor sounds in the NICU will be minimized, and the staff will be instructed to speak quietly to maintain a calm environment.

OTHERControl Group (standard feeding )

The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.


Locations(1)

Acibadem University

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07068581


Related Trials