Effect of Maternal Voice on Physiological Indicators and Feeding Performance
NCT ID: NCT07068581
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-08-10
2026-07-23
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Standard feeding group
This group will not be exposed to maternal voice before or during feeding; standard feeding care will be provided.
Control Group (standard feeding )
The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.
Interventions
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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.
Control Group (standard feeding )
The control group will not be exposed to maternal voice, and standard feeding procedures will be applied.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
1 Day
28 Days
ALL
Yes
Sponsors
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Acibadem University
OTHER
Responsible Party
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Semra Küçük
Research Assistant
Principal Investigators
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Semra Küçük, Research Assistant,Phd Student
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
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Acibadem University
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Semra Küçük, Research Assistant,Phd Student
Role: CONTACT
Phone: 0216- 544- 3666
Email: [email protected]
Facility Contacts
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semra Kucuk, Research Assistant,Phd Student
Role: primary
Semra Küçük, Research Assistant
Role: backup
References
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Hamm EL, Chorna OD, Stark AR, Maitre NL. Feeding outcomes and parent perceptions after the pacifier-activated music player with mother's voice trial. Acta Paediatr. 2015 Aug;104(8):e372-4. doi: 10.1111/apa.13030. Epub 2015 May 16. No abstract available.
Chorna OD, Slaughter JC, Wang L, Stark AR, Maitre NL. A pacifier-activated music player with mother's voice improves oral feeding in preterm infants. Pediatrics. 2014 Mar;133(3):462-8. doi: 10.1542/peds.2013-2547. Epub 2014 Feb 17.
Chirico G, Cabano R, Villa G, Bigogno A, Ardesi M, Dioni E. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit. Acta Paediatr. 2017 Oct;106(10):1564-1568. doi: 10.1111/apa.13944. Epub 2017 Jul 5.
Chhikara A, Hagadorn JI, Lainwala S. Effect of maternal voice on proportion of oral feeding in preterm infants. J Perinatol. 2023 Jan;43(1):68-73. doi: 10.1038/s41372-022-01493-4. Epub 2022 Aug 18.
Alabbasi Y, Parker L, Weaver M, Krueger C. Maternal Voice Exposure and Its Effect on Premature Infants' Feeding Milestones: A Systematic Review. Adv Neonatal Care. 2023 Apr 1;23(2):E40-E49. doi: 10.1097/ANC.0000000000001029. Epub 2022 Oct 3.
Other Identifiers
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ATADEK-2025/09
Identifier Type: -
Identifier Source: org_study_id