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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 28 days
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Turkey
Acibadem University
RECRUITING
Istanbul
Contact Information
Primary
Semra Küçük, Research Assistant,Phd Student
semra.kucuk@acibadem.edu.tr
0216- 544- 3666
Backup
Duygu Gözen, Professor Doctor
dugozen@ku.edu.tr
0212-311-2640
Time Frame
Start Date: 2025-08-10
Estimated Completion Date: 2026-07-23
Participants
Target number of participants: 50
Treatments
Experimental: Maternal voice group
The maternal voice will be played twice daily, starting 20 minutes before the morning and evening oral feedings and continuing throughout the feeding session.
Other: Standard feeding group
This group will not be exposed to maternal voice before or during feeding; standard feeding care will be provided.
Related Therapeutic Areas
Sponsors
Leads: Acibadem University

This content was sourced from clinicaltrials.gov