]>
IRCT20250609066134N1 IRCT 2025-09-29 Yazd University of Medical Sciences 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. 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. 2025-07-11 anticipated 76 Complete https://irct.ir/trial/84307 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: Our study has no unique design features, Randomization description: 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. N/A stress. Intervention 1: Intervention group: In this group, in addition to regular NICU visits, a guided visit is held daily for 45 to 60 minutes for 14 days. In these sessions, training is provided on understanding the NICU environment, prematurity, infection control, mental health, life skills, stress management, and relaxation techniques (such as deep breathing and mindfulness). The sessions also include questions and answers and a summary. Intervention 2: Control group: In this group, fathers simply had routine NICU visits and did not receive any educational or guided interventions. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: 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. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public zahra pourmovahed
Shahrekord, Saadi Street, Alley 71
Shahrekord Iran (Islamic Republic of) 8817714684 +98 38 3326 4821 movahed446@yahoo.com Yazd University of Medical Sciences scientific zahra pourmovahed
Shahrekord, Saadi Street, Alley 71
Shahrekord Iran (Islamic Republic of) 8817714684 +98 38 3326 4821 movahed446@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study No previous history of the baby being admitted to the NICU Being able to read and write in Persian Premature baby between 28 and 36 weeks of age The father must have Iranian citizenship Absence of any mental illness in the past 6 months No significant abnormalities in the baby No separation or divorce between parents Current NICU admission of the newborn no limit no limit Male Use of sedatives and psychotropic drugs Participating in care and stress management courses in the past F43.0 Acute stress reaction Other Other Intervention group: In this group, in addition to regular NICU visits, a guided visit is held daily for 45 to 60 minutes for 14 days. In these sessions, training is provided on understanding the NICU environment, prematurity, infection control, mental health, life skills, stress management, and relaxation techniques (such as deep breathing and mindfulness). The sessions also include questions and answers and a summary. Control group: In this group, fathers simply had routine NICU visits and did not receive any educational or guided interventions. Stress scores of fathers of premature infants in the Cohen Stress Questionnaire. Timepoint: Before the intervention, immediately after the intervention, and one month after the intervention. Method of measurement: Cohen Stress Questionnaire. Yazd University of Medical Sciences Approved 2025-05-13 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Shahrekord, Saadi Street, Alley 71 yazd Yazd Iran (Islamic Republic of)