Effect of a Trauma-Informed Mobile-Based Education-Support Program Compared with Usual Care on Stress, Anxiety, and Maternal Self-Efficacy among Mothers of Preterm Infants

To determine the effect of a trauma-informed mobile-based education and support program, compared with usual care, on parental stress, anxiety, and perceived maternal self-efficacy among mothers of preterm infants hospitalized in the neonatal intensive care unit.

Randomized, two-arm, parallel-group clinical trial of 60 mothers (30 per group), with 1:1 block randomization using blocks of four and concealed allocation; statistical analysis will be blinded.

Randomized clinical trial with two parallel groups, 60 mothers (30 per group), block randomization with blocks of four at a 1:1 ratio, unblinded participants, and a blinded data analyst; trial phase not applicable.

Participants/Inclusion and Exclusion Criteria ـ English Key inclusion criteria: Mothers of preterm infants born at less than 37 weeks of gestation; infant hospitalized in the neonatal intensive care unit for at least 72 hours at the beginning of the study; maternal age of 18 years or older; ability to read and write; access to a smartphone and ability to use WhatsApp or telephone communication; written informed consent. Key exclusion criteria: Major congenital anomalies, genetic disorders, or severe neurological disorders in the infant; critical and unstable clinical condition of the infant; severe psychiatric disorders or cognitive impairment in the mother; lack of access to a smartphone.

Intervention Groups Intervention group: Receiving a trauma-informed mobile-based education and support program for 4 consecutive weeks, comprising educational text content, audio guidance files, and supportive messages via a mobile messenger, in addition to routine neonatal intensive care unit care.

Maternal stress, anxiety, and self-efficacy at the end of the fourth week of the intervention

Participants will be allocated to the intervention and control groups using blocked randomization. Permuted blocks of four will be used with a 1:1 allocation ratio between the be performed control groups. The unit of randomization will be the individual eligible mother, and allocation will be performed at the individual level. No stratified randomization will be used in this study. The randomization sequence will be generated using statistical software by a person independent of the intervention implementation team, preferably a statistician. After completion of the pretest, group allocation will be performed using sequentially numbered, sealed, opaque envelopes. The contents of the envelopes will remain concealed from the researcher and the participant until the time of allocation. Due to the educational nature of the intervention, blinding of the participants and the interventionist will not be possible. However, the statistical analysis will be conducted by a statistician who will be unaware of the participants’ group assignments.

Due to the thesis-based and single-center nature of the study, limited resources, and the requirements of the Ethics Committee of Dezful University of Medical Sciences regarding the protection of participants’ privacy and confidentiality, there is no plan to share individual participant data (IPD). Data will only be reported at the group level in a summarized form in the final thesis report and any related publications.