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IRCT20260721070284N1 IRCT 2026-08-11 Islamic Azad University 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 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 2026-08-16 anticipated 60 Complete https://irct.ir/trial/92017 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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. N/A Preterm Infant. Intervention 1: Intervention group: In addition to receiving routine ward care, the intervention group will receive an educational program based on the family-centered care model individually in 4 sessions, each session lasting 60 minutes. Educational content is based on the stages of the family-centered care model and using a variety of educational methods, including: face-to-face education, presentation of educational brochures, structured discussions and dialogues, practical demonstrations, skills practice with feedback, educational videos, situation simulations, problem solving, active participation of the mother in care, and questions and answers. In the first session, the condition of the premature baby, possible problems and complications, the importance of proper care, the consequences of lack of proper care, and the role of the family in care are taught, and the needs and concerns of the mothers are identified. In the second session, basic skills for caring for premature babies are taught and practiced, including: drug care, monitoring vital signs, identifying warning signs, and daily care. In the third session, additional training in feeding, soothing the baby, solving potential problems, shared decision-making, and determining the role of family members in care is provided, and problem-solving skills are practiced. In the fourth session, the materials and skills taught are reviewed, learning and skills of mothers are assessed, and the home care plan and post-discharge actions are explained. Intervention 2: Control group: During the study period, the control group will only receive routine ward care according to the usual hospital schedule, and no intervention based on the family-centered care model will be implemented for them. Yes - There is a plan to make this available What will be shared: 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 When: 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.” To whom: 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 Conditions: "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." Where to obtain: “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.” How to obtain: 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." Comments: “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).”
public Fatemeh Khodadadi
University Blvd, Islamic Azad University, Aliabad Katoul Branch
Aliabad Katoul Iran (Islamic Republic of) 4941793451 +98 17 3422 4500 behinakhodadadi@gmail.com Islamic Azad University scientific Nafiseh Hekmatipour
University Blvd, Islamic Azad University, Aliabad Katoul Branch
Aliabad Katoul Iran (Islamic Republic of) 4941793451 +98 17 3422 4500 N_hekmati68@yahoo.com Islamic Azad University Iran (Islamic Republic of) 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 18 years no limit Female 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 P07.3 Preterm [premature] newborn [other] Behavior N/A Intervention group: In addition to receiving routine ward care, the intervention group will receive an educational program based on the family-centered care model individually in 4 sessions, each session lasting 60 minutes. Educational content is based on the stages of the family-centered care model and using a variety of educational methods, including: face-to-face education, presentation of educational brochures, structured discussions and dialogues, practical demonstrations, skills practice with feedback, educational videos, situation simulations, problem solving, active participation of the mother in care, and questions and answers. In the first session, the condition of the premature baby, possible problems and complications, the importance of proper care, the consequences of lack of proper care, and the role of the family in care are taught, and the needs and concerns of the mothers are identified. In the second session, basic skills for caring for premature babies are taught and practiced, including: drug care, monitoring vital signs, identifying warning signs, and daily care. In the third session, additional training in feeding, soothing the baby, solving potential problems, shared decision-making, and determining the role of family members in care is provided, and problem-solving skills are practiced. In the fourth session, the materials and skills taught are reviewed, learning and skills of mothers are assessed, and the home care plan and post-discharge actions are explained. Control group: During the study period, the control group will only receive routine ward care according to the usual hospital schedule, and no intervention based on the family-centered care model will be implemented for them. Parenting self-efficacy score. Timepoint: Before the intervention (pre-test), immediately after the intervention (post-test), and one month after the intervention. Method of measurement: Parenting Self-Efficacy Questionnaire by Domka et al. (1996). Infant care quality score. Timepoint: Before the intervention (pre-test), immediately after the intervention (post-test), and one month after the intervention. Method of measurement: Winsley and Gettys Quality of Infant Care Questionnaire (2013). Islamic Azad University Approved 2026-07-12 Ethics Committee of Aliabad Katoul Branch, Islamic Azad University University Blvd, Islamic Azad University, Aliabad Katoul Branch Aliabad Katoul Golestan Iran (Islamic Republic of)