Effect of Maternal Voice on Physiological Indicators and Feeding Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorAcibadem University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Maternal voice
Procedure/SurgeryMothers 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.
Control Group (standard feeding )
Other interventionThe control group will not be exposed to maternal voice, and standard feeding procedures will be applied.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Maternal voice groupExperimental treatment 1 intervention
Group B: Standard feeding groupOther 1 intervention
Trial outcomes
Primary outcomes
1
Change in Oral Feeding Performance
Oral feeding performance will be measured using the 'Oral Feeding Maturation Monitoring Device.' One of the device's sensors is positioned under the infant's chin, and the other is placed on the chest. The device evaluates the infant's sucking-swallowing-breathing coordination during a 2-minute feeding session.
Time frame
The first day the infant transitions to full oral feeding and the 5th day will be evaluated. The change between these time points will be assessed.2
Change in oxygen saturation
Preterm infant will be monitored and oxygen saturation will be monitored.
Time frame
Oxygen saturation will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.3
Change in heart rate
Preterm infant will be monitored and heart rate will be monitored.
Time frame
Heart rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.4
Change in respiratory rate
Preterm infant will be monitored and respiratory rate will be monitored.
Time frame
Respiratory rate will be measured once daily for five days. Data will be collected immediately before, during, immediately after feeding. The change in these time intervals will be assessed.Sponsors and contacts
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Source ClinicalTrials.gov