PrematureNCT06958471
The Effect of Individualized Developmental Care Education
A study testing Individualized Developmental Care Education Group in people with Premature and Self Efficacy, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. 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
- Premature, Self Efficacy, Attachment
- What is being tested?
- Individualized Developmental Care Education Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2025to 30 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The mother must have a premature baby born between 22 and 32 weeks gestation, admitted to a level 3 NICU.
- The baby's stay in the level 3 NICU must be at least one month.
- The mother must not have any diagnosed psychiatric disorders.
- The baby must not have severe congenital anomalies incompatible with life.
- The mother must be literate and open to communication.
- The mother must be willing and volunteer to participate in the research.
Who cannot join
- The baby's stay in the NICU must be at least one month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Individualized Developmental Care Education Given to Mothers of Premature Infants on Maternal Self-Efficacy and Attachment Levels
This study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. Premature birth can be a stressful and anxiety-inducing experience for mothers, which may negatively impact their self-confidence and ability to establish an emotional bond with their baby.
Structured and individualized developmental care education provided in the neonatal intensive care unit (NICU) enhances mothers' knowledge and promotes their active participation in the care process, thereby strengthening their maternal roles. Increased self-efficacy helps mothers to take a more active and conscious role in their infant's care, while stronger maternal attachment plays a critical role in the infant's emotional and neurodevelopmental health.
Therefore, the integration and dissemination of such supportive educational interventions within the healthcare system are essential steps that can positively influence both maternal and infant health outcomes.
- Conditions
- Premature, Self Efficacy, Attachment, Maternal
- Being tested
- Individualized Developmental Care Education Group
- Keywords
- Premature, Individualized Developmental Care, Attachment, Self Efficacy, Maternal
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Developmental Care Education GroupBehavioural
An educational program will be implemented for the mothers in the intervention group throughout the hospitalization period of their premature infants, in line with the objectives of the study.
P1:Pretests for the mothers will be completed within the first three days of the infant's admission to the neonatal intensive care unit (NICU). Mothers will be given a brochure titled "Your Premature Baby", prepared by the researcher, which includes information about the NICU and its staff, visiting hours/conditions, and breast milk expression times.
P2:Education will be provided on the characteristics, feeding, and care of premature infants.
P3:Mothers will receive training on environmental regulations (temperature, light, sound), kangaroo care,non-nutritive sucking, and parent-infant interaction. Each training session will be delivered each lasting no longer than 30-45 minutes.
P4:A final training session will be provided on home care for the premature infant.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Developmental Care Education Group | Experimental | Before the mother is discharged from the hospital after delivery (within 24 hours for a vaginal birth and within 72 hours for a cesarean section), a brochure titled "Your Premature Baby" prepared by the researcher will be provided. The content of the "Infant Care and Nutrition" booklet to be given to mothers will include information on breastfeeding, infant care, home environment, screening tests, immunization, common problems, and other related topics.
In the second and third weeks, individualized developmental care training tailored to the needs of the newborn will be provided. This training will cover topics such as environmental adjustments (light, noise, temperature), kangaroo care, infant massage, non-nutritive sucking, and parent-infant bonding.
In the fourth week, the mothers' application of the training and their knowledge levels regarding premature infant care will be assessed. Receives: Behavioral: Individualized Developmental Care Education Group |
| Control group | No intervention | During the hospitalization of the premature infant, routine nursing education provided in the clinic will be delivered to the mother by the unit nurse. These routine trainings and information sessions include the following: A brief information session of approximately 5 minutes, usually given to all mothers within the first 24 hours after birth, covering topics such as breast milk expression, breastfeeding positions, and the benefits of breast milk. Mothers selected for kangaroo care are given information regarding hand hygiene and personal cleanliness. On weekdays, between 1:00 p.m. and 2:00 p.m., the neonatologist provides information to parents about the general condition of their baby in the NICU. To prevent ethical concerns arising from the implementation of the study in terms of the control group, after the posttest is completed, the researcher will provide the control group families with the information they need. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The General Self-Efficacy Scale consists of 17 items. The total score can range from 17 to 85; higher scores indicate a greater belief in self-efficacy.
Measured: The first three days of hospitalization and one month after hospitalization
Maternal Attachment Levels
Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104; higher scores indicate a stronger level of maternal attachment.
Measured: The first three days of hospitalization and one month after hospitalization
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 start7 Apr 2025
- Primary completion29 Aug 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Randomized controlled and Quasi-experimental research
- Masking
- None (open label)
- Enrolment
- 54 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, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958471
- Sponsor's protocol ID
- Emel Avcin Indı. Deve. Care
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2025
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individualized Developmental Care Education Given to Mothers of Premature Infants on Maternal Self-Efficacy and Attachment Levels
- ClinicalTrials.gov ID
- NCT06958471
- Acronym / sponsor ID
- Emel Avcin Indı. Deve. Care
- Conditions
- Premature, Self Efficacy, Attachment, Maternal
- Keywords
- Premature, Individualized Developmental Care, Attachment, Self Efficacy, Maternal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (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.
This study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. Premature birth can be a stressful and anxiety-inducing experience for mothers, which may negatively impact their self-confidence and ability to establish an emotional bond with their baby.
Structured and individualized developmental care education provided in the neonatal intensive care unit (NICU) enhances mothers' knowledge and promotes their active participation in the care process, thereby strengthening their maternal roles. Increased self-efficacy helps mothers to take a more active and conscious role in their infant's care, while stronger maternal attachment plays a critical role in the infant's emotional and neurodevelopmental health.
Therefore, the integration and dissemination of such supportive educational interventions within the healthcare system are essential steps that can positively influence both maternal and infant health outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled and Quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Individualized Developmental Care Education Group | Experimental | Behavioral: Individualized Developmental Care Education GroupBefore the mother is discharged from the hospital after delivery (within 24 hours for a vaginal birth and within 72 hours for a cesarean section), a brochure titled "Your Premature Baby" prepared by the researcher will be provided. The content of the "Infant Care and Nutrition" booklet to be given to mothers will include information on breastfeeding, infant care, home environment, screening tests, immunization, common problems, and other related topics. In the second and third weeks, individualized developmental care training tailored to the needs of the newborn will be provided. This training will cover topics such as environmental adjustments (light, noise, temperature), kangaroo care, infant massage, non-nutritive sucking, and parent-infant bonding. In the fourth week, the mothers' application of the training and their knowledge levels regarding premature infant care will be assessed. |
| Control group | No intervention | –During the hospitalization of the premature infant, routine nursing education provided in the clinic will be delivered to the mother by the unit nurse. These routine trainings and information sessions include the following: A brief information session of approximately 5 minutes, usually given to all mothers within the first 24 hours after birth, covering topics such as breast milk expression, breastfeeding positions, and the benefits of breast milk. Mothers selected for kangaroo care are given information regarding hand hygiene and personal cleanliness. On weekdays, between 1:00 p.m. and 2:00 p.m., the neonatologist provides information to parents about the general condition of their baby in the NICU. To prevent ethical concerns arising from the implementation of the study in terms of the control group, after the posttest is completed, the researcher will provide the control group families with the information they need. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The mother must have a premature baby born between 22 and 32 weeks gestation, admitted to a level 3 NICU.
- The baby's stay in the level 3 NICU must be at least one month.
- The mother must not have any diagnosed psychiatric disorders.
- The baby must not have severe congenital anomalies incompatible with life.
- The mother must be literate and open to communication.
Key exclusion criteria (1 listed)
- The baby's stay in the NICU must be at least one month.
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 |
|---|---|---|
| Individualized Developmental Care Education GroupAn educational program will be implemented for the mothers in the intervention group throughout the hospitalization period of their premature infants, in line with the objectives of the study. P1:Pretests for the mothers will be completed within the first three days of the infant's admission to the neonatal intensive care unit (NICU). Mothers will be given a brochure titled "Your Premature Baby", prepared by the researcher, which includes information about the NICU and its staff, visiting hours/conditions, and breast milk expression times. P2:Education will be provided on the characteristics, feeding, and care of premature infants. P3:Mothers will receive training on environmental regulations (temperature, light, sound), kangaroo care,non-nutritive sucking, and parent-infant interaction. Each training session will be delivered each lasting no longer than 30-45 minutes. P4:A final training session will be provided on home care for the premature infant. | Behavioural | Individualized Developmental Care Education Group |
Primary outcome
Self-Efficacy
Time frame: The first three days of hospitalization and one month after hospitalization
Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The General Self-Efficacy Scale consists of 17 items. The total score can range from 17 to 85; higher scores indicate a greater belief in self-efficacy.
Maternal Attachment Levels
Time frame: The first three days of hospitalization and one month after hospitalization
Pretests will be administered within the first three days of the mother's admission to the hospital with her premature infant, and posttests will be conducted at the end of the first month. The Maternal Attachment Scale consists of 26 items. The total score can range from 26 to 104; higher scores indicate a stronger level of maternal attachment.
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 18 Feb 2026.
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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.
EMEL AVÇİN, Doctor principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Developmental Care Education Group in people with Premature and Self Efficacy, 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 6 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 18 Feb 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?
Self-Efficacy (time frame: The first three days of hospitalization and one month after hospitalization). 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 18 Feb 2026.