- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07597954
Reciprocal Mother-Infant Voice Exposure in the Neonatal Intensive Care Unit
May 14, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Nilgün Avcı
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: Routine Care Group
Standard NICU care without auditory stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
12th postpartum hour
|
|
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).
|
12th postpartum hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
12th postpartum hour
|
|
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.
|
12th postpartum hour
|
|
Perceived Insufficient Milk
Time Frame: 12th postpartum hour
|
Measured using the Perceived Insufficient Milk Scale.
Higher scores indicate greater perceived milk insufficiency.
|
12th postpartum hour
|
|
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).
|
Between 6th and 12th postpartum hours
|
|
Neonatal Physiological Parameters
Time Frame: 6th, 8th, 10th, and 12th postpartum hours
|
Respiratory Rate: Measured in breaths per minute.
|
6th, 8th, 10th, and 12th postpartum hours
|
|
Oxygen Saturation
Time Frame: 6th, 8th, 10th, and 12th postpartum hours.
|
Peripheral oxygen saturation measured as percentage (%).
|
6th, 8th, 10th, and 12th postpartum hours.
|
|
Heart Rate
Time Frame: 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)
Time Frame: 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)
Time Frame: Between 6th and 12th postpartum hours.
|
Partial pressure of carbon dioxide measured in mmHg.
|
Between 6th and 12th postpartum hours.
|
|
Blood pH
Time Frame: Between 6th and 12th postpartum hours.
|
Blood pH measured as a unitless value.
|
Between 6th and 12th postpartum hours.
|
|
Blood Lactate Level
Time Frame: Between 6th and 12th postpartum hours.
|
Blood lactate level measured in mmol/L.
|
Between 6th and 12th postpartum hours.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
May 6, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 20, 2026
Study Record Updates
Last Update Posted (Actual)
May 20, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Respiration Disorders
- Infant, Premature, Diseases
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Respiratory Distress Syndrome, Newborn
- Respiratory Distress Syndrome
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Feeding Behavior
- Tachypnea
- Transient Tachypnea of the Newborn
- Breast Feeding
Other Study ID Numbers
- Reciprocal Mother-Infant Voice
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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