Examining the impact of mental health education through guided visits on the stress levels of fathers with preterm infants hospitalized in the neonatal intensive care unit.

Determining the effect of mental health education through guided visits on the stress of fathers of premature infants hospitalized in the neonatal intensive care unit

Randomization: Participants randomly assigned using numbered envelopes based on a random number table (odd = intervention, even = control). Sampling: Convenience sampling of eligible fathers of premature infants in NICU, Shahid Sadoughi Hospital, Yazd. Sample size: 38 per group (total 76). Trial phase: Phase 2.

This clinical psychology study at Shahid Sadoughi Hospital’s NICU involves fathers of premature infants divided into intervention and control groups. The intervention group receives stress-reduction training, while the control group receives standard care. Data are collected via questionnaires over a 14-day intervention with one-month follow-up.

Inclusion criteria: Father's consent to participate in the study, current hospitalization of the premature infant (28 to 36 weeks) in the NICU, no history of previous hospitalization of the infant, father's proficiency in Persian, Iranian nationality, father's mental and physical health in the past 6 months, no significant abnormality in the infant, and no separation or divorce of the parents. Exclusion criteria: Use of psychotropic or sedative medications, and father's history of participation in stress management courses.

Control group:Routine NICU visits (3 times/week, 45 minutes); stress measured before and after.Intervention group:Routine plus daily guided visits (45-60 minutes for 14 days) with education; stress measured before, immediately after, and one month later.

Perceived stress levels of fathers of premature infants

To select the samples, a simple random sampling method was used using a random number table. First, the starting point of the table was randomly selected. Then, to assign the samples to the test and control groups, the table was moved horizontally. The numbers in the table were extracted in four digits and assigned to the samples. If the extracted number was greater than the total number of samples, that number was eliminated and we moved on to the next number. The samples that were assigned odd numbers were assigned to the test group and the samples that were assigned even numbers were assigned to the control group. This process was carried out using sealed envelopes to completely preserve the random assignment process.

Individual participant data will be shared as an SPSS file after all identifiable information has been removed. This file contains all variables used in the study and allows researchers to use and re-analyze. Data sharing will occur after the study is fully completed.

Access to de-identified data will be available six months after the publication of the final study results and will continue for three years thereafter.

Data and documentation are provided only to researchers and faculty members active in universities and medical science research centers. Requests for access by other individuals or organizations are subject to review and approval by the ethics committee and research team.

In addition to the above requirements, applicants must provide their research objectives in writing and commit that the data will be used solely for research purposes. Any commercial use, publication, or sharing without written permission is prohibited. Applicants must also commit to maintaining the confidentiality of the data and adhering to research ethics. The use of the data will be limited to analyses related to the study topic, and any use beyond this will require re-approval from the research team.

First respondent: Ms. Zahra Pourmovahed, faculty member of the Faculty of Nursing and Midwifery, Shahid Sadoughi University of Medical Sciences, Yazd. Email: movahed446@yahoo.com Mobile: +989133511600. Second respondent: Ms. Sanaz Nikbakht Asl, master's student in neonatal intensive care nursing. Email: sanaznikbakht1379@yahoo.com Mobile: +989380771335. Postal address: Shahrekord, Saadi Gharbi Street, Alley 71.

After submitting the request to one of the above-mentioned responders, the request will be reviewed and approved. If approved, the preparation and submission of data or documentation will begin. This process usually takes between 2 and 4 weeks and depends on the volume of the request and the amount of data preparation. If more information or final approval is needed, the responder will contact the applicant.