Breast MilkNCT06741176
The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit
A study testing Experimental in people with Breast Milk and Premature, run by Semra Kose at 1 site in Turkey (Türkiye).
Trial summary
Newborn babies may need to stay in neonatal intensive care units (NICU) immediately after birth for many reasons such as premature birth, low birth weight, respiratory distress, infection, jaundice. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Milk, Premature
- What is being tested?
- Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 15 Jun 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in the care of the baby,
- Reading and understanding Turkish,
Who cannot join
- No psychological problems in the mother
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit to Their Babies on Mother-Baby Attachment and Hope Level: Randomized Controlled Study
Newborn babies may need to stay in neonatal intensive care units (NICU) immediately after birth for many reasons such as premature birth, low birth weight, respiratory distress, infection, jaundice. Depending on the cause and level of the newborn's illness, the length of stay may be extended, lasting weeks or even months. This situation negatively affects mother-infant bonding, causing mothers to be unable to establish healthy communication with their babies. For mothers in particular, leaving their babies in the NICU makes them feel inadequate and hopeless.
Attachment is the emotional bond that a baby establishes with its mother or the person who cares for it. This bond established between the mother and the baby affects the emotional, social, cognitive and moral development of the individual throughout their life. It is known that secure attachment contributes to the physical and mental development of babies, while insecure attachment is associated with various mental illnesses. For these reasons, it is important to initiate secure attachment between the mother and the baby during the neonatal period.
The aim of this planned study is to examine the effect of the messages left by mothers whose babies are in the NICU on mother-infant bonding and the mothers' level of hope. Mothers leaving messages for their babies provides a context in which they can express themselves to their babies and may positively affect mother-infant bonding and the mother's level of hope in the NICU.
Read the detailed description
Babies in the first four weeks (0-28 days) after birth are called newborns. The newborn period is a high-risk period for babies, and during this period, newborns need optimal care to survive. In 2018, 2.5 million newborns lost their lives due to preventable causes. NICUs are intensive care units equipped with high technology to meet all the needs of newborns; consisting of neonatologists, neonatologists and neonatal intensive care nurses. There may be many reasons for a baby to be admitted to the NICU. Some of these are; premature birth, low birth weight, respiratory distress, infection, jaundice, malnutrition, perinatal hypoxia, congenital heart disease, metabolic disorders and other congenital anomalies. While the baby's stay in the intensive care unit is necessary for its vital functions, this process also negatively affects the mother-baby bonding process. The mother breastfeeding her baby, ensuring early skin-to-skin contact, staying in the same room, the process of getting used to the role of motherhood, the social support the mother receives after birth are some of the factors that affect mother-baby bonding. The hospitalization of a baby disrupts the mother-baby relationship and can harm the mental health of parents and the development of babies. Parents face problems such as hopelessness, stress, psychological distress, loss of parental role and disruption of mother-baby bonding. The hospitalization of a baby in the NICU creates a traumatic effect on the family and disrupts bonding. Therefore, it is important to effectively initiate and develop mother-baby bonding for the health and future of the mother and baby. Hope is a dynamic force that empowers the individual to adapt to the future, enables them to be interested in their current life and the future and find meaning in it, supports well-being and helps maintain relationships with others. The lack of knowledge about the diagnosis and treatment procedures of babies admitted to neonatal units, the uncertainty of the prognosis, the reactions of the baby and most importantly, the lack of sufficient explanations from healthcare professionals can be shown as factors that lead to hopelessness in mothers. Other factors that increase hopelessness are the mother's inability to decide when to visit her baby, when to see the doctor and when to get information from healthcare professionals. The neonatal nurses who accept the baby can play an active role in the hope of the mother whose baby is hospitalized for her baby to grow and develop healthily. Creating a comfortable environment during the admission where the mother will perceive herself as a part of the unit rather than a visitor, welcoming the baby and the family, the nurse who will care for the baby introducing herself to the family, showing the place where the baby will stay and introducing the unit and providing information about this can reduce the anxiety and fear of the parents and the hopelessness of the mother who cannot hold her baby in her arms and breastfeed. On the other hand, mothers being with their babies and participating in their care at the earliest possible stage in this process can contribute to the bonding process, the growth and development of the baby, and the reduction of parents' hopelessness regarding their babies and the development of their problem-solving skills regarding baby care. Although there are studies in the literature on the hopelessness levels of mothers receiving care in the NICU and on mother-infant attachment in the NICU, no randomized controlled study has been found that included mothers leaving messages for their babies. Therefore, the aim of the planned study was to examine the effects of the messages left by mothers whose babies are in the NICU on mother-infant attachment and the mothers' level of hope.
- Conditions
- Breast Milk, Premature
- Being tested
- Experimental, Control
- Keywords
- Premature, breast milk, Mother, attachment, Hope
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalBehavioural
The research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The mothers in the experimental group will be asked to write messages to their babies on the milk bags they bring in the mornings for 3 days. They will be asked to write on the paper attached to the milk bag what they want to tell their baby that the investigators will read the message to them and to return it every morning. The post-test of all surveys will be conducted at the end of the 3rd day.
ControlBehavioural
The research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The post-tests will be conducted 3 days after the pre-test without any messages being requested from the mothers in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Breast Milk Receives: Behavioral: Experimental |
| Control | Active comparator | Control Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Information Form
The form, which was developed by the researcher by scanning the literature, has a total of 16 questions. It includes questions such as the mother's age, occupation, education level, baby's gender, weight, and week of birth.
Measured: It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)
Mother-Infant Bonding Scale
The eight-item scale filled out by the mother consists of eight items that include the emotional states the mother feels towards her baby after birth. The scale items consist of a four-point Likert-type rating, from "(0) very much" to "(3) never". Five items indicating negative emotions are scored in reverse (3-0). A high score indicates that the mother and baby have a bonding problem. The internal consistency coefficient of the scale was reported as 0.66 in the validity and reliability study.
Measured: Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)
State Hope Scale
The Turkish validity and reliability study of the State Hope Scale developed by Snyder et al. (1996) was conducted by Bekmezci et al. (2021). The statements in the Hope Scale were measured with an eight-point Likert (1=Absolutely false, 8=Absolutely true). The State Hope Scale consists of 2 dimensions: active thought and the ability to think of alternative ways to reach the goal. Questions 1, 3 and 5 in the scale measure the ability to think of alternative ways to reach the goal; questions 2, 4 and 6 measure the active thought dimension. High scores from the dimensions indicate high hope.
Measured: Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Aug 2024
- Primary completion15 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MilkStudies of the same condition, open and under way.
- 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
- Model description
- It is a randomized controlled trial in experimental design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semra Kose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Semra Kose, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741176
- Sponsor's protocol ID
- NEU2024breastmilk
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 4 Sep 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Message Left by Mothers Whose Babies Are in the Neonatal Intensive Care Unit to Their Babies on Mother-Baby Attachment and Hope Level: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06741176
- Acronym / sponsor ID
- NEU2024breastmilk
- Conditions
- Breast Milk, Premature
- Keywords
- Premature, breast milk, Mother, attachment, Hope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Semra KoseUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 18 Dec 2024 (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.
Newborn babies may need to stay in neonatal intensive care units (NICU) immediately after birth for many reasons such as premature birth, low birth weight, respiratory distress, infection, jaundice. Depending on the cause and level of the newborn's illness, the length of stay may be extended, lasting weeks or even months. This situation negatively affects mother-infant bonding, causing mothers to be unable to establish healthy communication with their babies. For mothers in particular, leaving their babies in the NICU makes them feel inadequate and hopeless.
Attachment is the emotional bond that a baby establishes with its mother or the person who cares for it. This bond established between the mother and the baby affects the emotional, social, cognitive and moral development of the individual throughout their life. It is known that secure attachment contributes to the physical and mental development of babies, while insecure attachment is associated with various mental illnesses. For these reasons, it is important to initiate secure attachment between the mother and the baby during the neonatal period.
The aim of this planned study is to examine the effect of the messages left by mothers whose babies are in the NICU on mother-infant bonding and the mothers' level of hope. Mothers leaving messages for their babies provides a context in which they can express themselves to their babies and may positively affect mother-infant bonding and the mother's level of hope in the NICU.
Detailed description
Babies in the first four weeks (0-28 days) after birth are called newborns. The newborn period is a high-risk period for babies, and during this period, newborns need optimal care to survive. In 2018, 2.5 million newborns lost their lives due to preventable causes. NICUs are intensive care units equipped with high technology to meet all the needs of newborns; consisting of neonatologists, neonatologists and neonatal intensive care nurses. There may be many reasons for a baby to be admitted to the NICU. Some of these are; premature birth, low birth weight, respiratory distress, infection, jaundice, malnutrition, perinatal hypoxia, congenital heart disease, metabolic disorders and other congenital anomalies. While the baby's stay in the intensive care unit is necessary for its vital functions, this process also negatively affects the mother-baby bonding process. The mother breastfeeding her baby, ensuring early skin-to-skin contact, staying in the same room, the process of getting used to the role of motherhood, the social support the mother receives after birth are some of the factors that affect mother-baby bonding. The hospitalization of a baby disrupts the mother-baby relationship and can harm the mental health of parents and the development of babies. Parents face problems such as hopelessness, stress, psychological distress, loss of parental role and disruption of mother-baby bonding. The hospitalization of a baby in the NICU creates a traumatic effect on the family and disrupts bonding. Therefore, it is important to effectively initiate and develop mother-baby bonding for the health and future of the mother and baby. Hope is a dynamic force that empowers the individual to adapt to the future, enables them to be interested in their current life and the future and find meaning in it, supports well-being and helps maintain relationships with others. The lack of knowledge about the diagnosis and treatment procedures of babies admitted to neonatal units, the uncertainty of the prognosis, the reactions of the baby and most importantly, the lack of sufficient explanations from healthcare professionals can be shown as factors that lead to hopelessness in mothers. Other factors that increase hopelessness are the mother's inability to decide when to visit her baby, when to see the doctor and when to get information from healthcare professionals. The neonatal nurses who accept the baby can play an active role in the hope of the mother whose baby is hospitalized for her baby to grow and develop healthily. Creating a comfortable environment during the admission where the mother will perceive herself as a part of the unit rather than a visitor, welcoming the baby and the family, the nurse who will care for the baby introducing herself to the family, showing the place where the baby will stay and introducing the unit and providing information about this can reduce the anxiety and fear of the parents and the hopelessness of the mother who cannot hold her baby in her arms and breastfeed. On the other hand, mothers being with their babies and participating in their care at the earliest possible stage in this process can contribute to the bonding process, the growth and development of the baby, and the reduction of parents' hopelessness regarding their babies and the development of their problem-solving skills regarding baby care. Although there are studies in the literature on the hopelessness levels of mothers receiving care in the NICU and on mother-infant attachment in the NICU, no randomized controlled study has been found that included mothers leaving messages for their babies. Therefore, the aim of the planned study was to examine the effects of the messages left by mothers whose babies are in the NICU on mother-infant attachment and the mothers' level of hope.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a randomized controlled trial in experimental design.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: ExperimentalBreast Milk |
| Control | Active comparator | Behavioral: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in the care of the baby,
- Reading and understanding Turkish,
Key exclusion criteria (1 listed)
- No psychological problems in the mother
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 |
|---|---|---|
| ExperimentalThe research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The mothers in the experimental group will be asked to write messages to their babies on the milk bags they bring in the mornings for 3 days. They will be asked to write on the paper attached to the milk bag what they want to tell their baby that the investigators will read the message to them and to return it every morning. The post-test of all surveys will be conducted at the end of the 3rd day. | Behavioural | Experimental |
| ControlThe research data will be collected with mothers whose babies are in the NICU. Information about the research will be given to mothers who come to leave milk for their babies and the research will be conducted with those who agree to participate. All surveys will be pre-tested on the mothers without randomization and the group they are in will be determined by randomization. The post-tests will be conducted 3 days after the pre-test without any messages being requested from the mothers in the control group. | Behavioural | Control |
Primary outcome
Sociodemographic Information Form
Time frame: It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)
The form, which was developed by the researcher by scanning the literature, has a total of 16 questions. It includes questions such as the mother's age, occupation, education level, baby's gender, weight, and week of birth.
Mother-Infant Bonding Scale
Time frame: Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)
The eight-item scale filled out by the mother consists of eight items that include the emotional states the mother feels towards her baby after birth. The scale items consist of a four-point Likert-type rating, from "(0) very much" to "(3) never". Five items indicating negative emotions are scored in reverse (3-0). A high score indicates that the mother and baby have a bonding problem. The internal consistency coefficient of the scale was reported as 0.66 in the validity and reliability study.
State Hope Scale
Time frame: Mothers who are breastfeeding for the first time will fill it out themselves on the first day (pre-test) and the 3rd day (post-test). (approximately 10 minutes)
The Turkish validity and reliability study of the State Hope Scale developed by Snyder et al. (1996) was conducted by Bekmezci et al. (2021). The statements in the Hope Scale were measured with an eight-point Likert (1=Absolutely false, 8=Absolutely true). The State Hope Scale consists of 2 dimensions: active thought and the ability to think of alternative ways to reach the goal. Questions 1, 3 and 5 in the scale measure the ability to think of alternative ways to reach the goal; questions 2, 4 and 6 measure the active thought dimension. High scores from the dimensions indicate high hope.
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 4 Sep 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 Experimental in people with Breast Milk and Premature, run by Semra Kose 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 2 inclusion and 1 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 4 Sep 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?
Sociodemographic Information Form (time frame: It will be applied to mothers who are breastfeeding for the first time by the researcher (approximately 5 minutes)). 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 4 Sep 2026.