Newborn InfantNCT07370025
The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants
A study testing Maternal Lullaby Singing in people with Newborn Infant and Bonding, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Newborn Infant, Bonding, Self Efficacy
- What is being tested?
- Maternal Lullaby Singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers who have had an uncomplicated pregnancy and delivery
- Mothers who are healthy enough to care for their baby
- Mothers who have suitable conditions at home to bathe their baby
- Babies born at term (≥ 37 weeks of gestation) and with stable general health after birth
Who cannot join
- Mothers with a history of serious postpartum complications (such as postpartum hemorrhage)
- Mothers diagnosed with psychiatric illness
- Mothers who are unable to participate directly in the care of their baby (due to severe disability, mandatory bed rest, etc.)
- Mothers who cannot participate in the lullaby program due to hearing impairment
- Infants who experience serious respiratory, cardiac, or neurological problems at birth or thereafter, who have a skin disease or dermatological condition that limits bathing, who have a history of admission to the neonatal intensive care unit, or who have a chronic disease or congenital anomaly
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul
Elif DOGAN, +90 539 601 15 88, elifdogann18@gmail.com
About this study
This randomized, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance.
The study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention.
Read more
Outcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments.
The findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.
- Conditions
- Newborn Infant, Bonding, Self Efficacy, Postpartum Depression (PPD)
- Being tested
- Maternal Lullaby Singing
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Lullaby SingingBehavioural
Mothers assigned to the intervention group will receive a brief structured education on infant bathing and the emotional role of maternal voice prior to hospital discharge. Following discharge, mothers will bathe their infants at home three times per week for two consecutive weeks (total of six sessions). During each bathing session, mothers will sing a lullaby using their own voice in a calm, quiet, and distraction-free environment. The lullaby may be a traditional cultural lullaby or spontaneous melodic humming. Recorded music will not be used. Each bathing session will last approximately 10-15 minutes, with water and room temperature adjusted to recommended neonatal care standards. Mothers will be encouraged to maintain eye contact, gentle touch, and emotional engagement with the infant throughout the bath. Researcher support will be provided via live video call during sessions to ensure adherence and safety.
| Study group | Role | What they receive |
|---|---|---|
| Lullaby Group | Experimental | Not described Receives: Behavioral: Maternal Lullaby Singing |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-Infant Bonding
Mother-infant bonding will be assessed using the Mother-to-Infant Bonding Scale, a validated self-report instrument consisting of 19 items measuring maternal emotional attachment, affection, and closeness toward the infant. Higher total scores indicate stronger mother-infant bonding. The total score that can be obtained on the scale ranges from 19 to 95.
Measured: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Postpartum Depressive Symptoms
Postpartum depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire widely used to screen for depressive symptoms during the postpartum period. Total scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.
Measured: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Perceived Maternal Parenting Self-Efficacy
Maternal parenting self-efficacy will be evaluated using the Perceived Maternal Parenting Self-Efficacy Scale, an 18-item self-report instrument assessing mothers' confidence in infant care, mother-infant interaction, and perceived ability to manage infant behaviors. Higher scores reflect greater perceived parenting self-efficacy.
The total score that can be obtained on the scale ranges from 18 to 72. High scores indicate that the mother feels competent in caring for and interacting with her baby.
Measured: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Dogan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07370025
- Sponsor's protocol ID
- 2025/728
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lullaby During Bath Time on Mother-Infant Bonding, Postpartum Depression, and Parental Self-Efficacy in Infants
- ClinicalTrials.gov ID
- NCT07370025
- Acronym / sponsor ID
- 2025/728
- Conditions
- Newborn Infant, Bonding, Self Efficacy, Postpartum Depression (PPD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 27 Jan 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, single-blind controlled trial aims to evaluate the effects of maternal lullaby singing during infant bathing on mother-infant bonding, postpartum depressive symptoms, and perceived parenting self-efficacy in mothers of healthy term infants. The postpartum period represents a critical phase for maternal psychological adjustment, during which stress, depressive symptoms, and low parenting confidence may negatively affect the quality of mother-infant interaction and bonding. Low-cost, culturally meaningful, and non-pharmacological interventions that support maternal well-being and early bonding are therefore of particular importance.
The study will be conducted with mothers who have delivered healthy term infants in a public hospital. Eligible participants will be randomly assigned to either an intervention group or a control group. Mothers in the intervention group will receive a structured bathing education and will be instructed to bathe their infants three times per week for two consecutive weeks while singing a lullaby using their own voice in a calm and quiet home environment. Live-recorded music will not be used. The intervention emphasizes sensory interaction, emotional closeness, and maternal voice as key components. Each bathing session is expected to last approximately 10-15 minutes. The control group will receive routine postpartum care without a structured lullaby-based bathing intervention.
Outcome measures include mother-infant bonding, postpartum depressive symptoms, and perceived maternal parenting self-efficacy. Data will be collected at two time points: prior to hospital discharge (within the first 24 hours postpartum) and at the end of the two-week intervention period. Validated self-report instruments will be used for all outcome assessments.
The findings of this study are expected to provide evidence on the effectiveness of a simple, culturally embedded caregiving practice in supporting maternal mental health, strengthening mother-infant bonding, and enhancing parenting confidence during the early postpartum period. Results may inform postpartum care practices, parental counseling programs, and midwife-led supportive interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lullaby Group | Experimental | Behavioral: Maternal Lullaby Singing |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Mothers who have had an uncomplicated pregnancy and delivery
- Mothers who are healthy enough to care for their baby
- Mothers who have suitable conditions at home to bathe their baby
- Babies born at term (≥ 37 weeks of gestation) and with stable general health after birth
Key exclusion criteria (5 listed)
- Mothers with a history of serious postpartum complications (such as postpartum hemorrhage)
- Mothers diagnosed with psychiatric illness
- Mothers who are unable to participate directly in the care of their baby (due to severe disability, mandatory bed rest, etc.)
- Mothers who cannot participate in the lullaby program due to hearing impairment
- Infants who experience serious respiratory, cardiac, or neurological problems at birth or thereafter, who have a skin disease or dermatological condition that limits bathing, who have a history of admission to the neonatal intensive care unit, or who have a chronic disease or congenital anomaly
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 |
|---|---|---|
| Maternal Lullaby SingingMothers assigned to the intervention group will receive a brief structured education on infant bathing and the emotional role of maternal voice prior to hospital discharge. Following discharge, mothers will bathe their infants at home three times per week for two consecutive weeks (total of six sessions). During each bathing session, mothers will sing a lullaby using their own voice in a calm, quiet, and distraction-free environment. The lullaby may be a traditional cultural lullaby or spontaneous melodic humming. Recorded music will not be used. Each bathing session will last approximately 10-15 minutes, with water and room temperature adjusted to recommended neonatal care standards. Mothers will be encouraged to maintain eye contact, gentle touch, and emotional engagement with the infant throughout the bath. Researcher support will be provided via live video call during sessions to ensure adherence and safety. | Behavioural | Lullaby Group |
Primary outcome
Mother-Infant Bonding
Time frame: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Mother-infant bonding will be assessed using the Mother-to-Infant Bonding Scale, a validated self-report instrument consisting of 19 items measuring maternal emotional attachment, affection, and closeness toward the infant. Higher total scores indicate stronger mother-infant bonding. The total score that can be obtained on the scale ranges from 19 to 95.
Postpartum Depressive Symptoms
Time frame: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Postpartum depressive symptoms will be measured using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire widely used to screen for depressive symptoms during the postpartum period. Total scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.
Perceived Maternal Parenting Self-Efficacy
Time frame: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.
Maternal parenting self-efficacy will be evaluated using the Perceived Maternal Parenting Self-Efficacy Scale, an 18-item self-report instrument assessing mothers' confidence in infant care, mother-infant interaction, and perceived ability to manage infant behaviors. Higher scores reflect greater perceived parenting self-efficacy. The total score that can be obtained on the scale ranges from 18 to 72. High scores indicate that the mother feels competent in caring for and interacting with her baby.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Lullaby Singing in people with Newborn Infant and Bonding, run by Istanbul University - Cerrahpasa 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elif DOGAN (+90 539 601 15 88, elifdogann18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-Infant Bonding (time frame: Baseline (within 24 hours postpartum, prior to hospital discharge) and at the end of the 2-week intervention period.). The study lists 3 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 30 Jan 2026.