NCT07597954

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

May 6, 2026

Last Update Submit

May 14, 2026

Conditions

Maternal AttachmentBreastfeedingTransient Tachypnea of the NewbornNeonatal Intensive Care Unit

Keywords

Maternal voiceAuditory stimulationNICUBreastfeeding outcomesMaternal attachmentRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Maternal Attachment

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

    12th postpartum hour

  • Breastfeeding Effectiveness

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

    12th postpartum hour

Secondary Outcomes (11)

  • Breastfeeding Self-Efficacy

    12th postpartum hour

  • Infant Feeding Intention

    12th postpartum hour

  • Perceived Insufficient Milk

    12th postpartum hour

  • Expressed Breast Milk Volume

    Between 6th and 12th postpartum hours

  • Neonatal Physiological Parameters

    6th, 8th, 10th, and 12th postpartum hours

  • +6 more secondary outcomes

Study Arms (2)

Reciprocal Voice Exposure Group

EXPERIMENTAL

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.

Behavioral: Reciprocal Voice Exposure Group

Routine Care Group

NO INTERVENTION

Standard NICU care without auditory stimulation.

Interventions

Reciprocal Voice Exposure GroupBEHAVIORAL

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.

Reciprocal Voice Exposure Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nilgün Avcı

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingTransient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorRespiratory Distress Syndrome, NewbornRespiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersTachypneaInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof.

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 20, 2026

Study Start

October 1, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

May 20, 2026

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)