NCT07068581

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Acibadem University · Academic / Other
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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.

Detailed description

Oral feeding is one of the critical milestones in the growth and development of preterm infants. A delay in achieving successful oral feeding skills may lead to prolonged hospitalization, negatively impact mother-infant bonding, result in long-term feeding difficulties, impair growth and development, and cause adverse neurodevelopmental outcomes. The literature reports that various methods have been used to enhance oral feeding performance, one of which is maternal voice. It has been reported that the maternal voice has a positive effect on the oral feeding performance of preterm infants. Continuing maternal vocal stimulation during the postnatal period (such as singing lullabies, reading books, or engaging in everyday speech) contributes to strengthening synaptic connections in the auditory cortex, increasing the brain's sensory processing capacity, reducing the infant's stress levels, and maintaining physiological stability. The maternal voice positively influences oral feeding performance by helping infants maintain an alert state and facilitating the coordination of sucking, swallowing, and breathing. In this regard, the maternal voice can be used as an evidence-based nursing intervention to enrich the care of preterm infants. However, the number of high-level evidence studies investigating the relationship between maternal voice and oral feeding performance is limited in the literature, and some existing studies report inconclusive results. Therefore, addressing this issue will help fill a gap in the literature. In this study, preterm infants in the experimental group will listen to a lullaby recorded in their own mother's voice before and during oral feeding, twice daily (morning and evening) for five consecutive days. A Bluetooth-enabled, speaker-equipped voice recorder will be used for each infant individually. No auditory intervention will be applied to the infants in the control group. In both groups, physiological indicators and oral feeding performance will be measured on specific days.

Conditions

• Preterm
• Oral Feeding Performance

Interventions

Type	Name	Description
PROCEDURE	Maternal 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.
OTHER	Control Group (standard feeding )	The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-07-23
• Completion: 2026-07-23
• First posted: 2025-07-16
• Last updated: 2025-12-18

Locations

1 site across 1 country: Turkey (Türkiye)