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Clinical Trials/NCT07597954
NCT07597954CompletedNot Applicable

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

Biruni University1 site in 1 country60 target enrollmentStarted: October 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Biruni University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nilgun Avci

Asist. Prof.

Biruni University

Study Sites (1)

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