MothersNCT06958458
Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit
A study testing Mother Integrated Care in people with Mothers and Premature, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. 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
- Mothers, Premature, Empowerment
- What is being tested?
- Mother Integrated Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2025to 1 Sep 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The newborn must be premature (gestational age >28 and <34 weeks),
- The infant must be admitted to the NICU and hospitalized for at least 3 days,
- The mother must be open to communication and cooperation,
- The mother must voluntarily agree to participate in the study,
- The mother must be literate,
- The mother must be able to speak and understand Turkish,
Show all 9Show fewer
- The mother must be primiparous and experiencing motherhood for the first time,
- The mother must be over 18 years of age,
- Mothers in the intervention group must be present in the hospital for an average of 6-8 hours per day.
Who cannot join
- The newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis),
- The newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, Down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases),
- The newborn has a congenital heart defect requiring surgical intervention,
- The mother has a diagnosed psychiatric illness,
- The mother and/or father do not wish to participate in the study.
- Withdrawal Criteria:
Show all 11Show fewer
- The mother does not attend the training sessions during the study period,
- The mother fails to maintain cooperation throughout the study,
- The newborn is transferred to another healthcare center for any reason,
- The mother wishes to withdraw from the study,
- The newborn is diagnosed with a chronic illness during the study process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit and the Impact of Their Integration Into Their Babies' Care Process on Maternal and Infant Outcomes: A Randomized Controlled Trial
Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. Through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. They are also educated on general hygiene and care tasks such as diaper changing and body cleaning. This model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. During this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. Family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. This model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.
- Conditions
- Mothers, Premature, Empowerment
- Being tested
- Mother Integrated Care
- Keywords
- Empowerment, Neonatal, Premature, Mothers, Nursing
- Medical subject headings
- Premature Birth, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother Integrated CareBehavioural
In order to empower mothers whose premature infants have been hospitalized in the neonatal intensive care unit (NICU) for at least three days, a four-step neonatal care training program will be provided. Through the empowerment of the mother, the empowerment of the motherwill also be supported. The family will no longer be considered as visitors but will be involved in the infant's care in the NICU as parents. Data collection forms will be completed before the training begins, one day prior to discharge, and one week after discharge.
| Study group | Role | What they receive |
|---|---|---|
| Mother Integrated Care Group | Experimental | Mothers whose babies are admitted to YYÜ will be contacted within the first 72 hours. Pre-test data (Information Form, Maternal Self-Efficacy, Attachment, Breastfeeding Self-Efficacy, Parental Stress, and Newborn Comfort Scales) will be collected, and the training schedule will be determined through face-to-face interviews.
After the interview with the mother and the pre-test are completed, the training date will be determined in consultation with the researchers. The training, consisting of four stages, is planned to be conducted at a rate of one session per day. Procedures will be demonstrated using mannequins and supported by a PowerPoint presentation and visual materials. A prepared booklet will also be distributed to the mothers. After the training phases are completed, mothers will be encouraged to participate in care as part of a team effort. One day before discharge and one and three months after discharge, survey forms will be completed via WhatsApp. Receives: Behavioral: Mother Integrated Care |
| Control group | No intervention | Mothers in this group will receive standard unit care and education. Data collection procedures will be the same as those used in the intervention group. The mother will be contacted within the first 72 hours after admission to the unit, and baseline data will be collected. One day before discharge, and one and three months after discharge, questionnaire forms will be completed via WhatsApp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Stress in the Neonatal Intensive Care Unit
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to assess the level of parental perception of stressors arising from the physical and psychosocial environment of the intensive care unit. The scale consists of 34 items across three dimensions: Sights and Sounds, Infant Appearance and Behavior, and Parental Role Alteration. Higher scores on the scale indicate higher levels of parental stress (minimum: 0, maximum: 170).
Measured: Within the first 72 hours of hospitalization, prior to discharge
Maternal Attachment
The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104. A higher score indicates a higher level of maternal attachment.
Measured: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
The Mother's Perceived Parenting Self-Efficacy
The scale was developed to assess the perceived self-efficacy of mothers of premature infants in caring for their babies and understanding their needs. The scale consists of a total of 20 items, and scores range from 20 to 80. A higher score indicates an increase in the mother's perceived parenting self-efficacy.
Measured: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants
The scale consists of 18 positive items that assess mothers of preterm infants' perceptions of self-efficacy regarding breastfeeding and milk expression. The total score ranges from 18 to 90, with a high score indicating high breastfeeding self-efficacy.
Measured: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
Newborn Comfort Behavior
The scale consists of six behavioral parameters that assess alertness, calmness/agitation, respiratory response or crying, body movements, facial tension, and muscle tone. Each parameter is scored on a scale of 1 to 5, and the total score ranges from 6 to 30. A high score indicates a decreased level of comfort in the newborn.
Measured: Within the first 72 hours of hospitalization, prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start30 Aug 2025
- Primary completion30 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MothersStudies 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
- This is a randomized controlled trial (RCT) designed to evaluate the effectiveness of an intervention.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel AVÇİN, University of Yalova
- Investigators
- EMEL AVÇİN, Doctor, Principal investigator, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958458
- Sponsor's protocol ID
- Emel A. Family Integrated Care
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Mothers Whose Babies Are Hospitalized in the Neonatal Intensive Care Unit and the Impact of Their Integration Into Their Babies' Care Process on Maternal and Infant Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06958458
- Acronym / sponsor ID
- Emel A. Family Integrated Care
- Conditions
- Mothers, Premature, Empowerment
- Keywords
- Empowerment, Neonatal, Premature, Mothers, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 6 May 2025 (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.
Family Integrated Care is designed to eliminate the barriers between parents and their infants in the NICU by involving parents of premature infants in their care. Parents are integrated into both the healthcare team and the care of their infant. Through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. They are also educated on general hygiene and care tasks such as diaper changing and body cleaning. This model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. During this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. Family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. This model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial (RCT) designed to evaluate the effectiveness of an intervention.
| Arm | Type | Receives |
|---|---|---|
| Mother Integrated Care Group | Experimental | Behavioral: Mother Integrated CareMothers whose babies are admitted to YYÜ will be contacted within the first 72 hours. Pre-test data (Information Form, Maternal Self-Efficacy, Attachment, Breastfeeding Self-Efficacy, Parental Stress, and Newborn Comfort Scales) will be collected, and the training schedule will be determined through face-to-face interviews. After the interview with the mother and the pre-test are completed, the training date will be determined in consultation with the researchers. The training, consisting of four stages, is planned to be conducted at a rate of one session per day. Procedures will be demonstrated using mannequins and supported by a PowerPoint presentation and visual materials. A prepared booklet will also be distributed to the mothers. After the training phases are completed, mothers will be encouraged to participate in care as part of a team effort. One day before discharge and one and three months after discharge, survey forms will be completed via WhatsApp. |
| Control group | No intervention | –Mothers in this group will receive standard unit care and education. Data collection procedures will be the same as those used in the intervention group. The mother will be contacted within the first 72 hours after admission to the unit, and baseline data will be collected. One day before discharge, and one and three months after discharge, questionnaire forms will be completed via WhatsApp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The newborn must be premature (gestational age >28 and <34 weeks),
- The infant must be admitted to the NICU and hospitalized for at least 3 days,
- The mother must be open to communication and cooperation,
- The mother must voluntarily agree to participate in the study,
- The mother must be literate,
Key exclusion criteria (11 listed)
- The newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis),
- The newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, Down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases),
- The newborn has a congenital heart defect requiring surgical intervention,
- The mother has a diagnosed psychiatric illness,
- The mother and/or father do not wish to participate in the study.
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 |
|---|---|---|
| Mother Integrated CareIn order to empower mothers whose premature infants have been hospitalized in the neonatal intensive care unit (NICU) for at least three days, a four-step neonatal care training program will be provided. Through the empowerment of the mother, the empowerment of the motherwill also be supported. The family will no longer be considered as visitors but will be involved in the infant's care in the NICU as parents. Data collection forms will be completed before the training begins, one day prior to discharge, and one week after discharge. | Behavioural | Mother Integrated Care Group |
Primary outcome
Parental Stress in the Neonatal Intensive Care Unit
Time frame: Within the first 72 hours of hospitalization, prior to discharge
The Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) will be used to assess the level of parental perception of stressors arising from the physical and psychosocial environment of the intensive care unit. The scale consists of 34 items across three dimensions: Sights and Sounds, Infant Appearance and Behavior, and Parental Role Alteration. Higher scores on the scale indicate higher levels of parental stress (minimum: 0, maximum: 170).
Maternal Attachment
Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104. A higher score indicates a higher level of maternal attachment.
The Mother's Perceived Parenting Self-Efficacy
Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
The scale was developed to assess the perceived self-efficacy of mothers of premature infants in caring for their babies and understanding their needs. The scale consists of a total of 20 items, and scores range from 20 to 80. A higher score indicates an increase in the mother's perceived parenting self-efficacy.
Breastfeeding Self-Efficacy Scale for Mothers of Preterm Infants
Time frame: Within the first 72 hours of hospitalization, prior to discharge, 1 month after discharge, and months after discharge
The scale consists of 18 positive items that assess mothers of preterm infants' perceptions of self-efficacy regarding breastfeeding and milk expression. The total score ranges from 18 to 90, with a high score indicating high breastfeeding self-efficacy.
Newborn Comfort Behavior
Time frame: Within the first 72 hours of hospitalization, prior to discharge
The scale consists of six behavioral parameters that assess alertness, calmness/agitation, respiratory response or crying, body movements, facial tension, and muscle tone. Each parameter is scored on a scale of 1 to 5, and the total score ranges from 6 to 30. A high score indicates a decreased level of comfort in the newborn.
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 21 Sep 2026.
Related trials for Mothers
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
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.
EMEL AVÇİN, Doctor principal investigator
Adiyaman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother Integrated Care in people with Mothers and Premature, run by University of Yalova 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 9 inclusion and 11 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 21 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?
Parental Stress in the Neonatal Intensive Care Unit (time frame: Within the first 72 hours of hospitalization, prior to discharge). The study lists 5 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 21 Sep 2026.