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IRCT20251020067698N4 IRCT 2026-08-26 Dezfoul University of Medical Sciences Effect of a Trauma-Informed Mobile-Based Education-Support Program on Mental Health of Mothers of Preterm Infants 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 2026-09-22 anticipated 60 Complete https://irct.ir/trial/92770 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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. N/A Stress and Anxiety in Mothers of Preterm Infants. Intervention 1: Intervention group: A 4-week trauma-informed mobile-based supportive educational program delivered via smartphone (WhatsApp or similar messaging platform). The program includes daily notifications, text/audio/visual educational content, a digital emotion journal, and researcher responses to educational and supportive questions during specified daily hours. Content is designed based on trauma-informed care principles (safety, trustworthiness, choice, collaboration, empowerment, and cultural sensitivity) and is structured weekly as follows:Week 1 (Familiarization and recognition of trauma responses): Education on traumatic reactions after preterm birth and NICU admission, postpartum anxiety, and recording feelings in a digital journal.Week 2 (Creating safety): Familiarization with the NICU environment, deep breathing and relaxation techniques (audio files), and reducing feelings of loss of control.Week 3 (Empowerment): Education on preterm infant care (touch therapy, feeding, interpreting infant behavioral cues), enhancing maternal self-efficacy, and positive mother-infant interaction.Week 4 (Discharge preparation): Home care plan, warning signs, personal care planning, and ongoing support.In addition to mobile content, an initial 20–30-minute face-to-face session is conducted by the researcher on the first day of study entry to introduce the program and the NICU environment. Daily 5–10-minute follow-ups, teach-back assessment of understanding, and empathic support using the NURSE framework in cases of severe anxiety are provided. After post-test completion, the educational content is provided to the control group for educational equity.Control group: Routine NICU care. This includes general and usual information about the infant’s condition provided by the shift healthcare staff (nurse or responsible physician). No structured educational package, audio files, digital journal, daily notifications, or planned educational sessions similar to the intervention group are provided. Intervention 2: Control group:Routine and usual care provided in the Neonatal Intensive Care Unit (NICU) of Dr. Ganjavian Hospital, Dezful. This includes general and day-to-day information about the infant’s clinical condition given by the shift healthcare staff (responsible nurse or physician) according to the standard unit protocol. Mothers in this group do not receive any structured educational package, educational audio files, digital emotion journal, daily notifications, trauma-informed mobile-based content, planned educational sessions, or regular supportive responses from the researcher. After completion of the post-test phase and to ensure educational equity, the full educational-supportive program content will also be provided to the mothers in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Mohammad Danehchin
Faculty of Nursing, Department of Nursing, Azadegan Campus, Dezful University of Medical Sciences, Dezful, Khuzestan Province, Iran
Dezful Iran (Islamic Republic of) 6461665145 +98 936 989 1730 Bahare.kord132@gmail.com Dezfoul University of Medical Sciences scientific Sara Kord
Dezful University of Medical Sciences and Health Services, Azadegan Boulevard, next to the Traffic Police Department, Dezful, Iran.
Dezfoul Iran (Islamic Republic of) 6461634534 +98 937 674 1216 bahare.kord132@gmail.com Dezfoul University of Medical Sciences Iran (Islamic Republic of) Being the mother of a preterm infant born at less than 37 weeks of gestation The infant having been hospitalized in the neonatal intensive care unit for at least 72 hours at the beginning of the studyBeing at least 18 years oldHaving the ability to read and write Having a smartphone and access to WhatsApp or telephone communication Willingness to participate in the study and signing the written informed consent form Not having a severe mental illness or cognitive impairment that could affect cooperation 18 years no limit Female The infant having a major congenital anomaly The infant having a known genetic disorder The infant having a severe neurological disorder The infant having a critical and unpredictable medical condition at the initial assessment Lack of access to a smartphone or inability to use WhatsApp or telephone communication The mother being unable to read and write The mother having a severe mental illness or cognitive impairment that could prevent study completion or effective cooperation Unwillingness to participate in the study or refusal to sign the written informed consent form P00.5 Newborn (suspected to be) affected by maternal injury Behavior Behavior Intervention group: A 4-week trauma-informed mobile-based supportive educational program delivered via smartphone (WhatsApp or similar messaging platform). The program includes daily notifications, text/audio/visual educational content, a digital emotion journal, and researcher responses to educational and supportive questions during specified daily hours. Content is designed based on trauma-informed care principles (safety, trustworthiness, choice, collaboration, empowerment, and cultural sensitivity) and is structured weekly as follows:Week 1 (Familiarization and recognition of trauma responses): Education on traumatic reactions after preterm birth and NICU admission, postpartum anxiety, and recording feelings in a digital journal.Week 2 (Creating safety): Familiarization with the NICU environment, deep breathing and relaxation techniques (audio files), and reducing feelings of loss of control.Week 3 (Empowerment): Education on preterm infant care (touch therapy, feeding, interpreting infant behavioral cues), enhancing maternal self-efficacy, and positive mother-infant interaction.Week 4 (Discharge preparation): Home care plan, warning signs, personal care planning, and ongoing support.In addition to mobile content, an initial 20–30-minute face-to-face session is conducted by the researcher on the first day of study entry to introduce the program and the NICU environment. Daily 5–10-minute follow-ups, teach-back assessment of understanding, and empathic support using the NURSE framework in cases of severe anxiety are provided. After post-test completion, the educational content is provided to the control group for educational equity.Control group: Routine NICU care. This includes general and usual information about the infant’s condition provided by the shift healthcare staff (nurse or responsible physician). No structured educational package, audio files, digital journal, daily notifications, or planned educational sessions similar to the intervention group are provided. Control group:Routine and usual care provided in the Neonatal Intensive Care Unit (NICU) of Dr. Ganjavian Hospital, Dezful. This includes general and day-to-day information about the infant’s clinical condition given by the shift healthcare staff (responsible nurse or physician) according to the standard unit protocol. Mothers in this group do not receive any structured educational package, educational audio files, digital emotion journal, daily notifications, trauma-informed mobile-based content, planned educational sessions, or regular supportive responses from the researcher. After completion of the post-test phase and to ensure educational equity, the full educational-supportive program content will also be provided to the mothers in the control group. Maternal stress score measured using the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS:NICU) before the intervention and four weeks after the intervention. Timepoint: Before the intervention and four weeks after the end of the intervention. Method of measurement: Parental Stressor Scale for the Neonatal Intensive Care Unit. Maternal anxiety score measured using the State-Trait Anxiety Inventory (STAI) before the intervention and four weeks after the intervention. Timepoint: Before the intervention and four weeks after the end of the intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory. Maternal self-efficacy score measured using the Perceived Maternal Self-Efficacy Scale (PMSE) before the intervention and four weeks after the intervention. Timepoint: Before the intervention and four weeks after the end of the intervention. Method of measurement: Perceived Maternal Self-Efficacy Scale. Dezfoul University of Medical Sciences Approved 2026-07-23 Ethics Committee of Dezful University of Medical Sciences Central Building, Dezful University of Medical Sciences, Payam-e Noor Blvd., Dezful Dezful Khouzestan Iran (Islamic Republic of)