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Reciprocal Mother-Infant Voice Exposure in the Neonatal Intensive Care Unit

14. maj 2026 opdateret af: Nilgun Avci, Biruni University

Hearing Each Other: Effects of Reciprocal Maternal-Infant Voice Exposure on Maternal Attachment and Breastfeeding in the NICU: A Randomized Controlled Trial

This randomized controlled trial evaluates the effect of reciprocal maternal-infant voice exposure on maternal attachment and breastfeeding outcomes in a neonatal intensive care unit (NICU). Infants in the intervention group are exposed to recordings of their mothers' voices, while mothers simultaneously listen to recordings of their infants' sounds between the 6th and 12th postpartum hours. The intervention is administered every 2 hours for 30 minutes. Outcomes include maternal attachment, breastfeeding effectiveness, breastfeeding self-efficacy, infant feeding intention, perceived insufficient milk, and expressed breast milk volume. Neonatal physiological parameters and blood gas values are also assessed. The findings aim to support family-centered NICU care through non-invasive auditory interventions.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Mothers aged ≥18 years
  • Infants ≥37 weeks gestation
  • Diagnosis of transient tachypnea of the newborn (TTN)
  • Infant admitted to NICU ≥6 hours
  • Ability to communicate in Turkish

Exclusion Criteria:

  • Infant clinical deterioration requiring transfer
  • Maternal psychiatric disorder
  • Hearing impairment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Reciprocal Voice Exposure Group
Reciprocal auditory stimulation consisting of maternal voice recordings played to infants and infant sound recordings played to mothers every 2 hours for 30 minutes between the 6th and 12th postpartum hours.
Adfærdsmæssigt: Reciprocal Voice Exposure Group
Reciprocal auditory stimulation consisting of maternal voice recordings played to infants and infant sound recordings played to mothers every 2 hours for 30 minutes between the 6th and 12th postpartum hours.
Ingen indgriben: Routine Care Group
Standard NICU care without auditory stimulation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal Attachment
Tidsramme: 12th postpartum hour
Measured using the Maternal Attachment Inventory (26 items; scores range from 26 to 104; higher scores indicate stronger attachment).
12th postpartum hour
Breastfeeding Effectiveness
Tidsramme: 12th postpartum hour
Measured using the Bristol Breastfeeding Assessment Tool (scores range from 0 to 8; higher scores indicate more effective breastfeeding).
12th postpartum hour

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Breastfeeding Self-Efficacy
Tidsramme: 12th postpartum hour
Measured using the Breastfeeding Self-Efficacy Scale-Short Form (14 items; scores range from 14 to 70; higher scores indicate greater self-efficacy).
12th postpartum hour
Infant Feeding Intention
Tidsramme: 12th postpartum hour
Measured using the Infant Feeding Intention Scale. Scores range from 0 to 16; higher scores indicate stronger intention to breastfeed.
12th postpartum hour
Perceived Insufficient Milk
Tidsramme: 12th postpartum hour
Measured using the Perceived Insufficient Milk Scale. Higher scores indicate greater perceived milk insufficiency.
12th postpartum hour
Expressed Breast Milk Volume
Tidsramme: Between 6th and 12th postpartum hours
Volume of breast milk expressed using an electric pump, measured in milliliters (mL).
Between 6th and 12th postpartum hours
Neonatal Physiological Parameters
Tidsramme: 6th, 8th, 10th, and 12th postpartum hours
Respiratory Rate: Measured in breaths per minute.
6th, 8th, 10th, and 12th postpartum hours
Oxygen Saturation
Tidsramme: 6th, 8th, 10th, and 12th postpartum hours.
Peripheral oxygen saturation measured as percentage (%).
6th, 8th, 10th, and 12th postpartum hours.
Heart Rate
Tidsramme: 6th, 8th, 10th, and 12th postpartum hours.
Heart rate measured in beats per minute (bpm).
6th, 8th, 10th, and 12th postpartum hours.
Partial Pressure of Oxygen (pO₂)
Tidsramme: Between 6th and 12th postpartum hours.
Partial pressure of oxygen measured in mmHg.
Between 6th and 12th postpartum hours.
Partial Pressure of Carbon Dioxide (pCO₂)
Tidsramme: Between 6th and 12th postpartum hours.
Partial pressure of carbon dioxide measured in mmHg.
Between 6th and 12th postpartum hours.
Blood pH
Tidsramme: Between 6th and 12th postpartum hours.
Blood pH measured as a unitless value.
Between 6th and 12th postpartum hours.
Blood Lactate Level
Tidsramme: Between 6th and 12th postpartum hours.
Blood lactate level measured in mmol/L.
Between 6th and 12th postpartum hours.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biruni University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2022

Primær færdiggørelse (Faktiske)

30. september 2023

Studieafslutning (Faktiske)

30. september 2023

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Reciprocal Mother-Infant Voice

Plan for individuelle deltagerdata (IPD)

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