The Effect of Family-Centered Care Model on Mothers' parenting self-efficacy Parenting Self-Efficacy and Quality of Care for Premature Infants Hospitalized in Teaching Hospitals

To determine the effect of implementing a family-centered care model on mothers' parenting self-efficacy and the quality of care for preterm infants hospitalized in teaching hospitals in Sari in 2026.

A randomized controlled trial (RCT) with pre-test, post-test, and one-month follow-up. Sample (n=72) allocated via block randomization (blocks of 4).

his study will be conducted in the NICUs of teaching hospitals in Sari

Mother of a preterm infant admitted to the neonatal intensive care unit Infant gestational age less than 37 weeks At least 48 hours and at most 7 days have passed since the infant's admission at the time of enrollment Mother aged 18 years or older Ability of the mother to read and write Willingness to participate in the study Written informed consent provided by the parents No diagnosed psychiatric disorder or acute family crisis Non-preterm infant with gestational age of 37 weeks or more Infant admission for less than 48 hours or more than 7 days at the time of enrollment Mother younger than 18 years Mother unable to read and write Unwillingness to participate in the study No written informed consent provided Presence of a diagnosed psychiatric disorder or an acute family crisis

Intervention group: Mothers receive 4 daily individual sessions (60 min each) covering preterm infant care, participation, emotional support, and discharge readiness. Control group: Receives only routine ward care.

Mothers' parenting self-efficacy and quality of care for preterm infants

After selecting participants using convenience sampling and meeting the inclusion criteria, individuals were assigned to the intervention and control groups using a block randomization method with blocks of four to maintain a balance of sample sizes in the two groups during the sampling process. For this purpose, a random allocation sequence was generated using the Randomization.com website. In this process, each participant's case number was considered as a unique sample code, and based on the generated random sequence, participants were assigned to the intervention and control groups with an allocation ratio of 1:1 (30 people in each group). In order to reduce allocation bias, the process of generating the random sequence and assigning participants to the study groups was performed by an individual outside the research team who had no role in sampling, implementing the intervention, collecting data, and analyzing the results. Also, to maintain allocation concealment, the random sequence was placed in Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE). After each participant entered the study and completed the admission process, the envelope corresponding to the assigned number was opened in order and the allocated group was determined. In this way, the researcher and participants were unaware of the allocated group before entering the study, and the possibility of bias in sample allocation was minimized.

he Impact of Implementing a Family-Centered Care Model on Mothers' Parenting Self-Efficacy and the Quality of Care for Preterm Infants Hospitalized in Teaching Hospitals of Sari, 2026

Data access will be available 6 months after the publication of the final study results. The exact publication date will be determined after the completion of data analysis and article acceptance in scientific journals.”

Access to the research data will be restricted to members of the core research team (including the Principal Investigator, research collaborators, and data analysts), Research Ethics Oversight Committees, and other researchers who obtain permission for access to de-identified, coded data by submitting a formal research proposal and obtaining approval from the Ethics Committee of Faculty of Medical Sciences, Islamic Azad University, Aliabad-e Katul Branch. Raw data containing direct participant identifiers will not be shared

"The data and documents from this research are to be used solely for non-commercial research and educational purposes. The use of de-identified, coded data is limited to analyses directly related to the objectives and research questions of the original study, including: Replication of Original Findings: Enabling the examination and reproduction of analyses reported in the primary publication. Secondary Analyses: Investigating novel relationships or supplementary hypotheses derived from the existing data that are directly relevant to the study topic (family-centered care, parenting self-efficacy, quality of preterm infant care). Use in Educational Projects: Sharing anonymized data samples with students and junior researchers for coursework or preliminary research projects, under the direct supervision of a faculty advisor. Requirements for Submitting a Data Access Request: Submission of a written research proposal clearly outlining the intended use of the data. Completion and signing of a Confidentiality Agreement provided by Islamic Azad University, Aliabad-e Katul Branch. Obtaining final approval from the Ethics Committee for Research at Faculty of Medical Sciences, Islamic Azad University, Aliabad-e Katul Branch. Commitment to not attempt re-identification of participants and to maintain complete data confidentiality. Agreement to properly cite the original study in all reports, publications, and presentations based on this data. Prohibition of re-publishing or selling the data to third parties."

“To submit a request for access to the data and documents of this research, please contact the Research Office of Islamic Azad University, Aliabad-e Katul Branch. Additionally, for initial coordination and to obtain the necessary forms, you may contact the Principal Investigator of the study, Ms. Fatemah Khodadadi.”

The process for requesting access to the data and documents of this research is as follows: Initial Submission: The applicant must submit a written request along with their research proposal to the Research Office of Islamic Azad University, Aliabad-e Katul Branch. Preliminary Proposal Review: The Research Office will review the proposal for alignment with the overall research objectives and completeness of initial documentation. Provision of Confidentiality Agreement: Upon preliminary approval, the Confidentiality Agreement form will be provided to the applicant for completion and signature. Submission to Ethics Committee: The completed proposal, signed confidentiality agreement, and other required documents will be forwarded to the Ethics Committee for Research at Faculty of Medical Sciences, Islamic Azad University, Aliabad-e Katul Branch for final review and approval. Ethics Committee Review and Approval: The Ethics Committee will review the request from research and ethical perspectives and, if necessary, issue supplementary instructions. Issuance of Access Permit: After obtaining approval from the Ethics Committee, an access permit will be issued, and the de-identified dataset and/or required documents will be provided to the applicant via secure email or a designated portal. Monitoring and Reporting: The Principal Investigator (Ms. Fatemeh Khodadadi) will oversee the appropriate use of the data. The applicant is obligated to submit the results of their research in the form of reports or articles to the Research Office and the Ethics Committee."

“This research was funded by the Research Deputy of Islamic Azad University, Aliabad-e Katul Branch. All study procedures were conducted in strict accordance with the ethical principles of medical research and with the necessary approvals from the Ethics Committee for Research at the University. We kindly request all researchers intending to use the data from this study to fully adhere to the previously mentioned guidelines and to cooperate with the core research team to collectively advance knowledge in maternal and neonatal health. For any further guidance, please contact the Research Office of Islamic Azad University, Aliabad-e Katul Branch or Ms. Fatemeh Khodadadi (Principal Investigator).”