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Completed

NCT Number: NCT07597954

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

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.

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Key information

Conditions

Maternal Attachment Behavior Breast Feeding Breastfeeding Congenital, Hereditary, and Neonatal Diseases and Abnormalities Feeding Behavior Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Neonatal Intensive Care Unit Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nilgün Avcı

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reciprocal Voice Exposure Group

Behavioral

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.

Primary outcomes

  1. Maternal Attachment

    Time frame: 12th postpartum hour

    Measured using the Maternal Attachment Inventory (26 items; scores range from 26 to 104; higher scores indicate stronger attachment).

  2. Breastfeeding Effectiveness

    Time frame: 12th postpartum hour

    Measured using the Bristol Breastfeeding Assessment Tool (scores range from 0 to 8; higher scores indicate more effective breastfeeding).

Secondary outcomes

  1. Breastfeeding Self-Efficacy

    Time frame: 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).

  2. Infant Feeding Intention

    Time frame: 12th postpartum hour

    Measured using the Infant Feeding Intention Scale. Scores range from 0 to 16; higher scores indicate stronger intention to breastfeed.

  3. Perceived Insufficient Milk

    Time frame: 12th postpartum hour

    Measured using the Perceived Insufficient Milk Scale. Higher scores indicate greater perceived milk insufficiency.

  4. Expressed Breast Milk Volume

    Time frame: Between 6th and 12th postpartum hours

    Volume of breast milk expressed using an electric pump, measured in milliliters (mL).

  5. Neonatal Physiological Parameters

    Time frame: 6th, 8th, 10th, and 12th postpartum hours

    Respiratory Rate: Measured in breaths per minute.

  6. Oxygen Saturation

    Time frame: 6th, 8th, 10th, and 12th postpartum hours.

    Peripheral oxygen saturation measured as percentage (%).

  7. Heart Rate

    Time frame: 6th, 8th, 10th, and 12th postpartum hours.

    Heart rate measured in beats per minute (bpm).

  8. Partial Pressure of Oxygen (pO₂)

    Time frame: Between 6th and 12th postpartum hours.

    Partial pressure of oxygen measured in mmHg.

  9. Partial Pressure of Carbon Dioxide (pCO₂)

    Time frame: Between 6th and 12th postpartum hours.

    Partial pressure of carbon dioxide measured in mmHg.

  10. Blood pH

    Time frame: Between 6th and 12th postpartum hours.

    Blood pH measured as a unitless value.

  11. Blood Lactate Level

    Time frame: Between 6th and 12th postpartum hours.

    Blood lactate level measured in mmol/L.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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