Maternal AttachmentNCT07597954
Reciprocal Mother-Infant Voice Exposure in the Neonatal Intensive Care Unit
A study testing Reciprocal Voice Exposure Group in people with Maternal Attachment and Breastfeeding, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maternal Attachment, Breastfeeding, Transient Tachypnea of the Newborn
- What is being tested?
- Reciprocal Voice Exposure Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infant clinical deterioration requiring transfer
- Maternal psychiatric disorder
- Hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Maternal Attachment, Breastfeeding, Transient Tachypnea of the Newborn, Neonatal Intensive Care Unit
- Being tested
- Reciprocal Voice Exposure Group
- Keywords
- Maternal voice, Auditory stimulation, NICU, Breastfeeding outcomes, Maternal attachment, Randomized controlled trial
- Medical subject headings
- Breast Feeding, Transient Tachypnea of the Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reciprocal Voice Exposure GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reciprocal Voice Exposure Group |
| Routine Care Group | No intervention | Standard NICU care without auditory stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Attachment
Measured using the Maternal Attachment Inventory (26 items; scores range from 26 to 104; higher scores indicate stronger attachment).
Measured: 12th postpartum hour
Breastfeeding Effectiveness
Measured using the Bristol Breastfeeding Assessment Tool (scores range from 0 to 8; higher scores indicate more effective breastfeeding).
Measured: 12th postpartum hour
Secondary outcomes (11)
Breastfeeding Self-Efficacy
Measured using the Breastfeeding Self-Efficacy Scale-Short Form (14 items; scores range from 14 to 70; higher scores indicate greater self-efficacy).
Measured: 12th postpartum hour
Infant Feeding Intention
Measured using the Infant Feeding Intention Scale. Scores range from 0 to 16; higher scores indicate stronger intention to breastfeed.
Measured: 12th postpartum hour
Perceived Insufficient Milk
Measured using the Perceived Insufficient Milk Scale. Higher scores indicate greater perceived milk insufficiency.
Measured: 12th postpartum hour
Expressed Breast Milk Volume
Volume of breast milk expressed using an electric pump, measured in milliliters (mL).
Measured: Between 6th and 12th postpartum hours
Neonatal Physiological Parameters
Respiratory Rate: Measured in breaths per minute.
Measured: 6th, 8th, 10th, and 12th postpartum hours
Oxygen Saturation
Peripheral oxygen saturation measured as percentage (%).
Measured: 6th, 8th, 10th, and 12th postpartum hours.
Heart Rate
Heart rate measured in beats per minute (bpm).
Measured: 6th, 8th, 10th, and 12th postpartum hours.
Partial Pressure of Oxygen (pO₂)
Partial pressure of oxygen measured in mmHg.
Measured: Between 6th and 12th postpartum hours.
Partial Pressure of Carbon Dioxide (pCO₂)
Partial pressure of carbon dioxide measured in mmHg.
Measured: Between 6th and 12th postpartum hours.
Blood pH
Blood pH measured as a unitless value.
Measured: Between 6th and 12th postpartum hours.
Blood Lactate Level
Blood lactate level measured in mmol/L.
Measured: Between 6th and 12th postpartum hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Oct 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AttachmentStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Avci, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597954
- Sponsor's protocol ID
- Reciprocal Mother-Infant Voice
- Status last verified
- Oct 2022
- First submitted
- 6 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Each Other: Effects of Reciprocal Maternal-Infant Voice Exposure on Maternal Attachment and Breastfeeding in the NICU: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07597954
- Acronym / sponsor ID
- Reciprocal Mother-Infant Voice
- Conditions
- Maternal Attachment, Breastfeeding, Transient Tachypnea of the Newborn, Neonatal Intensive Care Unit
- Keywords
- Maternal voice, Auditory stimulation, NICU, Breastfeeding outcomes, Maternal attachment, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reciprocal Voice Exposure Group | Experimental | Behavioral: Reciprocal Voice Exposure GroupReciprocal 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. |
| Routine Care Group | No intervention | –Standard NICU care without auditory stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Infant clinical deterioration requiring transfer
- Maternal psychiatric disorder
- Hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reciprocal Voice Exposure GroupReciprocal 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. | Behavioural | Reciprocal Voice Exposure Group |
Primary outcome
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).
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).
11 secondary outcomes
Breastfeeding Self-Efficacy
Time frame: 12th postpartum hour
Infant Feeding Intention
Time frame: 12th postpartum hour
Perceived Insufficient Milk
Time frame: 12th postpartum hour
Expressed Breast Milk Volume
Time frame: Between 6th and 12th postpartum hours
Neonatal Physiological Parameters
Time frame: 6th, 8th, 10th, and 12th postpartum hours
Oxygen Saturation
Time frame: 6th, 8th, 10th, and 12th postpartum hours.
Heart Rate
Time frame: 6th, 8th, 10th, and 12th postpartum hours.
Partial Pressure of Oxygen (pO₂)
Time frame: Between 6th and 12th postpartum hours.
Partial Pressure of Carbon Dioxide (pCO₂)
Time frame: Between 6th and 12th postpartum hours.
Blood pH
Time frame: Between 6th and 12th postpartum hours.
Blood Lactate Level
Time frame: Between 6th and 12th postpartum hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reciprocal Voice Exposure Group in people with Maternal Attachment and Breastfeeding, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Attachment (time frame: 12th postpartum hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.