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IRCT20180722040555N6 IRCT 2026-05-18 Islamic Azad University Effect of Orem-Based Care on Mothers’ Self-Efficacy and Mother–Infant Bonding The Effect of a Care Model Based on Orem's Theory on Self-Efficacy and Attachment in Mothers of Infants Attending Health Centers in Shahrekord: A Clinical Trial 2026-08-11 anticipated 60 Recruiting https://irct.ir/trial/89904 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Implementation of Orem’s self-care model for the intervention group is designed as a six-session program. Each session lasts 60 to 90 minutes and is held weekly at the comprehensive health service center or, based on the mother’s preference, either face-to-face at the health centers (in compliance with health protocols) or in a virtual or hybrid format according to the mothers’ choice.The content of the sessions is structured based on the three levels of Orem’s nursing system wholly compensatory, partly compensatory, and supportive educative and aims to empower mothers in caring for their infants, Randomization description: Participants will be randomly allocated into intervention and control groups after completing the baseline questionnaire. Randomization will be performed using a random number table. Each participant will be assigned a specific code, and based on the random numbers, she will be allocated to either the intervention or control group. Allocation will be performed with an equal ratio (1:1) between the two groups. To reduce selection bias, group allocation will be carried out by a person other than the main researcher/intervention provider.Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes. Due to the nature of the educational/supportive intervention, blinding of participants and the intervention provider is not feasible. However, if possible, the outcome assessor/data analyst will be kept unaware of group allocation. N/A Maternal self-care Maternal, self-efficacy Mother–infant, bonding Orem’s self-care theory–based, education Maternal and child health / infant care. Intervention 1: Intervention group: The intervention consists of implementing Orem’s self-care model through six weekly sessions, each lasting 60 to 90 minutes, delivered in person or virtually. The sessions aim to empower primiparous mothers in infant care, including education on feeding, daily care, recognition of danger signs, infant developmental needs, maternal self-care, and anxiety reduction. Educational booklets and weekly home practice assignments complement the sessions. Intervention 2: Control group: In this study, mothers in the control group will receive only the routine care provided by health centers, and no additional educational intervention will be administered to them during the study period. Routine care includes the standard maternal and infant care services delivered according to the current guidelines of the national health system at comprehensive health service centers. To address ethical considerations and ensure equal access to educational materials, an educational booklet related to the study topic will be provided to the mothers in the control group after the completion of the intervention period and data collection. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Currently, no definite decision has been made regarding sharing the de-identified individual participant data (IPD). After study completion and ethical and legal considerations, data sharing may be planned if feasible.
public Forogh Okhovat
Rahmatiyeh – Islamic Azad University
Shahrekord Iran (Islamic Republic of) 8813733395 +98 913 287 5717 foroghokhovat92@gmail.com Islamic Azad University scientific Forogh Okhovat
Rahmatiyeh – Islamic Azad University
Shahrekord Iran (Islamic Republic of) 8813733395 +98 913 287 5717 foroghokhovat92@gmail.com Islamic Azad University Iran (Islamic Republic of) Primiparous mothers (first-time mothers) Having an infant aged 0 to 6 months Infant without any chronic disease, congenital anomaly, or neurological problem Infant born at term (gestational age 37–42 weeks No known psychiatric disorders in the mother (based on health records or self-report) No history of hospitalization of the mother or infant during the postpartum period due to serious medical conditions Ability to read and write in Persian (for completing questionnaires) Residence in Shahrekord or its suburbs (for accessibility and follow-up) Willingness to participate and completion of the informed consent form No concurrent participation in other similar studies No use of psychotropic medications no limit no limit Female Absence from more than one educational session Hospitalization of the infant during the study period Development of acute mental or physical illness in the mother during the study Voluntary withdrawal from participation in the study Other Other Intervention group: The intervention consists of implementing Orem’s self-care model through six weekly sessions, each lasting 60 to 90 minutes, delivered in person or virtually. The sessions aim to empower primiparous mothers in infant care, including education on feeding, daily care, recognition of danger signs, infant developmental needs, maternal self-care, and anxiety reduction. Educational booklets and weekly home practice assignments complement the sessions. Control group: In this study, mothers in the control group will receive only the routine care provided by health centers, and no additional educational intervention will be administered to them during the study period. Routine care includes the standard maternal and infant care services delivered according to the current guidelines of the national health system at comprehensive health service centers. To address ethical considerations and ensure equal access to educational materials, an educational booklet related to the study topic will be provided to the mothers in the control group after the completion of the intervention period and data collection. Maternal self-efficacy score measured by the Maternal Self‑Efficacy Questionnaire at the end of the intervention, assessing the mother’s ability to care for her infant. Mother–infant bonding score measured by the Postpartum Bonding Questionnaire at the end of the intervention, evaluating the emotional connection between mother and infant. Timepoint: At the baseline, before the intervention begins,At the end of the intervention after completion of the educational sessions. Method of measurement: Maternal self-efficacy is measured using the Maternal Self-Efficacy Questionnaire, a validated tool assessing the mother’s confidence in caring for her infant.Mother–infant bonding is measured using the Postpartum Bonding Questionnaire, a standardized instrument evaluating the emotional connection between mother and infant. This secondary outcome assesses the mother’s quality of life after the educational intervention, measured by a validated questionnaire covering physical, emotional, and mental health aspects. Timepoint: At baseline before the intervention,At the end of the intervention. Method of measurement: The secondary outcome of quality of life is measured using the Short Form Health Survey with 12 questions, which assesses the mother’s physical and mental health. Islamic Azad University Approved 2026-04-08 Research Ethics Committees of Islamic Azad University Shahrekord Branch Rahmatieh, Islamic Azad University of Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)