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IRCT20260601069597N2 IRCT 2026-08-20 The Hormozgan University of Medical Sciences Effect of an empowering educational intervention on performance and adjustment to the maternal role Investigating the effect of an empowering educational intervention on the performance and adjustment to the maternal role in mothers with premature infants: A randomized controlled clinical trial 2026-08-11 anticipated 96 Complete https://irct.ir/trial/90528 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A block randomization method will be used to allocate eligible participants to the three study groups, namely the researcher-led education group, the self-learning group, and the control group, with an allocation ratio of 1:1:1. The unit of randomization will be the individual mother. No stratified randomization will be used. The randomization sequence will be generated using the Random Allocation Software, with four blocks of 24 participants each. Each block will contain 8 participants allocated to each of the three study groups. After enrollment of each eligible participant, the corresponding allocation code will be assigned according to the pre-generated randomization sequence. To ensure allocation concealment, the randomization sequence will be generated by an individual independent of the researcher responsible for participant recruitment and outcome assessment. The allocation codes will be placed in sequentially numbered, opaque, sealed envelopes. The envelope corresponding to each participant will be opened only after the participant has been enrolled and completed the baseline assessment, thereby revealing the assigned study group, Blinding description: In order to double-blind the study, the data analyst and outcome assessors will be unaware of the group allocation. The data analyst will not be aware of the group allocation and will conduct the analysis under the names of groups A, B, C, and in order to blind the outcome assessors, a person outside the research team who has no knowledge of the grouping will measure the outcomes and only see the mothers' numbered code, not which group they are in. N/A Maternal functioning/Maternal role Adaptation. Intervention 1: First Intervention Group (Researcher-Led Education Group): Participants assigned to this group will receive the structured educational package developed for the study through four weekly group-based sessions, each lasting 60–90 minutes. Each session will be conducted in groups of five participants and delivered directly by the researcher. In session 1, the characteristics of preterm infants, their specific needs following hospital discharge, and common health problems encountered by preterm infants will be discussed. In session 2, the content will focus on the importance and significance of the maternal role, the mother’s role in caring for a preterm infant, and empowerment-oriented education on providing care for the preterm infant at home. In session 3, the educational content will address maternal psychological well-being, mothers’ physical and psychological preparedness, self-care, and sources of maternal social support. In session 4, the previously presented content will be reviewed, followed by discussion of mother–infant interaction, parental communication skills with the infant, and maternal self-efficacy. The session will also provide a supportive environment in which mothers can express their feelings, concerns, and questions. Positive thinking and maternal strengths will be encouraged, and participants’ questions and concerns will be addressed at the end of the session. Intervention 2: Second Intervention Group (Self-Learning Group):Participants assigned to this group will receive a printed version of the structured educational package developed for the study from the researcher on a weekly basis. The educational content will be provided in four consecutive sections over a 4-week period, such that the participants will receive the complete educational package by the end of the fourth week. The educational content provided to this group will be identical in terms of topics and educational materials to that delivered to the researcher-led education group. However, unlike the researcher-led education group, participants in the self-learning group will receive the educational materials in printed form and will study the content independently without attending face-to-face educational sessions. Participants will be instructed to study and review each section during the corresponding week. Intervention 3: Control Group: Participants assigned to the control group will receive routine post-discharge care for their infants according to the usual practice of the hospital and high-risk infant clinic. This care will consist of the standard care routinely provided by nursing staff and the healthcare team in accordance with the usual institutional procedures and practices. No additional structured educational intervention from the study educational package will be provided to participants in the control group. Yes - There is a plan to make this available What will be shared: The anonymized raw data from the maternal functioning and motherhood adjustment questionnaires, along with the variable coding file and research protocol, will be made available to researchers after the publication of the main study results. When: All identifying information about participants is removed and the data is presented in aggregated or anonymized form. Data will be available for 5 years from the publication of the original article or the end of the study, upon reasonable request from researchers and after approval by the principal investigator. To whom: Researchers, faculty members, and research students who submit a justified scientific request and accept the commitment to maintain the confidentiality of participant information. Conditions: The anonymized data will be used for research and educational purposes only. Use of the data is subject to formal request, approval from the principal investigator, and adherence to the principles of confidentiality and research ethics. Publication or commercial use of the data will not be permitted without written permission. Where to obtain: Applicants can submit their application through the principal investigator of the project or the faculty/research center conducting the study. How to obtain: The applicant must submit a written request including the purpose of using the data and their research plan. After the request is reviewed by the principal investigator and the principles of confidentiality and research ethics are ensured, the anonymized data will be made available to the applicant. The response time to requests will be a maximum of two weeks. m.banaei@hums.ac.ir Comments: All shareable data will be anonymized before being released to applicants, and no identifying information about participants will be made available to third parties. Data sharing will be conducted in accordance with research ethics and university regulations.
public Mojdeh Banaei
Hormozgan University of Medical Sciences and Health Services, Shahid Chamran Blvd., Bandar Abbas
Bandar Abbas Iran (Islamic Republic of) 13885-79166 +98 76 3333 3280 m.banaei@hums.ac.ir HoHormozgan University of Medical Sciences scientific Mojdeh Banaei
Bandar Abbas, Shahid Chamran Blvd, Hormozgan University of Medical Sciences and Health Services
Bandar Abbas Iran (Islamic Republic of) 13885-79166 +98 76 3333 3280 m.banaei@hums.ac.ir Hormozgan University of Medical Sciences Iran (Islamic Republic of) Iranian nationality Resident of Hormozgan province Ability to read and write Married Mothers with premature babies born with a gestational age of 28 weeks to 33 weeks and 6 days Mothers whose babies were less than 4 months old at the time of study entry Mothers with babies discharged from the neonatal ward and neonatal intensive care unit of Shariati Hospital, Bandar Abbas city, referring to the hospital's high-risk clinic Having a contact number for follow-up Singleton baby Willingness to participate in the study Having a healthy premature baby Mother as the primary caregiver of the baby after discharge Barkin maternal functioning score <80 no limit no limit Female A history of cardiovascular disease, hypertension, liver disease, or other chronic medical conditions in the mother, based on self-report. A current psychiatric or neurological disorder in the mother, based on self-report. Current substance misuse in the mother, based on self-report. A major personal or family crisis experienced by the mother within the preceding 6 months, based on self-report. A major adverse life event, such as the death of a close relative or divorce, experienced by the mother within the preceding 3 months, based on self-report. A severe and unresolved breastfeeding problem at the time of enrollment. A confirmed high-risk status for intraventricular hemorrhage in the infant. P07.3 Preterm [premature] newborn [other] Rehabilitation Rehabilitation Rehabilitation First Intervention Group (Researcher-Led Education Group): Participants assigned to this group will receive the structured educational package developed for the study through four weekly group-based sessions, each lasting 60–90 minutes. Each session will be conducted in groups of five participants and delivered directly by the researcher. In session 1, the characteristics of preterm infants, their specific needs following hospital discharge, and common health problems encountered by preterm infants will be discussed. In session 2, the content will focus on the importance and significance of the maternal role, the mother’s role in caring for a preterm infant, and empowerment-oriented education on providing care for the preterm infant at home. In session 3, the educational content will address maternal psychological well-being, mothers’ physical and psychological preparedness, self-care, and sources of maternal social support. In session 4, the previously presented content will be reviewed, followed by discussion of mother–infant interaction, parental communication skills with the infant, and maternal self-efficacy. The session will also provide a supportive environment in which mothers can express their feelings, concerns, and questions. Positive thinking and maternal strengths will be encouraged, and participants’ questions and concerns will be addressed at the end of the session. Second Intervention Group (Self-Learning Group):Participants assigned to this group will receive a printed version of the structured educational package developed for the study from the researcher on a weekly basis. The educational content will be provided in four consecutive sections over a 4-week period, such that the participants will receive the complete educational package by the end of the fourth week. The educational content provided to this group will be identical in terms of topics and educational materials to that delivered to the researcher-led education group. However, unlike the researcher-led education group, participants in the self-learning group will receive the educational materials in printed form and will study the content independently without attending face-to-face educational sessions. Participants will be instructed to study and review each section during the corresponding week. Control Group: Participants assigned to the control group will receive routine post-discharge care for their infants according to the usual practice of the hospital and high-risk infant clinic. This care will consist of the standard care routinely provided by nursing staff and the healthcare team in accordance with the usual institutional procedures and practices. No additional structured educational intervention from the study educational package will be provided to participants in the control group. Maternal Functioning. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Barkin Index of Maternal Functioning (BIMF). Maternal Role Adaptation. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Maternal role adaptation questionnaire. Postpartum maternal bonding. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Postpartum Bonding Questionnaire. Infant Weight. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Infant Growth and Clinical Follow-up Checklist. Infant Length. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Infant Growth and Clinical Follow-up Checklist. Infant Head Circumference. Timepoint: Before the start of the intervention and at weeks 4 and 8 after initiation of the intervention. Method of measurement: Infant Growth and Clinical Follow-up Checklist. The Hormozgan University of Medical Sciences Approved 2025-12-06 Ethics Committee of Hormozgan University of Medical Sciences Hormozgan University of Medical Sciences and Health Services, Shahid Chamran Blvd., Bandar Abbas Bandar Abbas Hormozgan Iran (Islamic Republic of)