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IRCT20250810066806N1 IRCT 2025-08-24 Shiraz University of Medical Sciences The Effect of Education on the Care Self-Efficacy of Adolescents Engaging in Non-Suicidal Self-Injury The Effect of Orem-Based Education on the Care Self-Efficacy of Adolescents Engaging in Non-Suicidal Self-Injury 2025-08-23 anticipated 36 Complete https://irct.ir/trial/85606 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The random sequence was generated by an independent statistician using block randomization with variable block sizes (4 and 6) and stratified by gender in SPSS software. To ensure allocation concealment, the sequence was placed in opaque, sealed, and sequentially numbered envelopes to prevent any prediction of group assignments in advance. Screening and enrollment of eligible participants were conducted by Researcher 1. After completion of the enrollment process and obtaining informed consent, the next envelope in sequence was opened, and group allocation was determined by Researcher 2, after which participants were assigned to the intervention or control groups. N/A Self-injury. Intervention 1: Intervention group: The questionnaires will be provided to the study participants via an online link. After completing the questionnaires, participants assigned to the intervention group will be enrolled in a virtual messaging network. Following an orientation session, the prepared educational materials—based on Orem’s Self-Care Model in the physical, social, psychological, and emotional domains—will be delivered in the form of video files, podcasts, and narrated PowerPoint presentations, developed by the Virtual Faculty. The materials will be shared with participants at a rate of two files per week over a four-week period.In the physical self-care domain, the training will focus on regular sleep, timely screening, exercise, proper medication use, and healthy nutrition, with the aim of improving the overall well-being of patients.In the emotional self-care domain, which emphasizes the recognition and processing of emotions in a healthy manner, the goal is to support patients in coping more effectively with life challenges, enhancing resilience, and fostering self-compassion. Topics include mindfulness, journaling, establishing healthy boundaries, and improving emotional communication.In the social self-care domain, with the aim of strengthening the sense of belonging, participants will receive training in areas such as joining groups and associations, active listening, and communication management.In the psychological self-care domain, targeting mental health promotion, the educational content will cover stress management, anger management, positive thinking, and goal setting.For each domain, four video files will be prepared by a specialist and shared with participants through the virtual network. After the four-week intervention, the questionnaires will again be distributed by the researcher to both the intervention and control groups, and the data will be collected for analysis. Intervention 2: Control group: Participants in the control group, after completing the baseline questionnaires, will continue to receive their usual care, such as visits with a psychologist or psychiatrist, if these services are already part of their routine treatment plan. At the end of the intervention period, the post-test questionnaires will be distributed to them via an online link. After data collection is completed, the educational materials provided to the intervention group will also be made available to the control group. Yes - There is a plan to make this available What will be shared: The de-identified individual data collected during the trial, including baseline characteristics and outcome measures, will be available upon reasonable request. No personally identifiable information will be shared. The datasets will be provided in electronic format after de-identification. When: The access period begins six months after the publication of the results. To whom: Researchers affiliated with scientific institutes and universities Conditions: The data can be utilized for longitudinal and retrospective research purposes. Where to obtain: Elham Mirshah Email: mirshah70@gmail.com Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Iran How to obtain: The requester can specify the reason and extent of access to the data, state the objectives of their study, and submit the request via email. Within one week after the request is received, the data will be provided if no specific issues exist. Comments:
public Shahrzad Yektatalab
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, at the entrance of Namazi Hospital, Namazi Square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3647 4254 nurs_midwif@sums.ac.ir Shiraz University of Medical Sciences scientific Shahrzad Yektatalab
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, at the entrance of Namazi Hospital, Namazi Square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 71936-13119 +98 71 3647 4254 nurs_midwif@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) History of Self-Injury Behavior Living with Parents Willingness to Participate in the Study Parental Consent for the Adolescent’s Participation in the Study 11 years 20 years Both Presence of Psychotic Disorders in the Adolescent Lifestyle Lifestyle Intervention group: The questionnaires will be provided to the study participants via an online link. After completing the questionnaires, participants assigned to the intervention group will be enrolled in a virtual messaging network. Following an orientation session, the prepared educational materials—based on Orem’s Self-Care Model in the physical, social, psychological, and emotional domains—will be delivered in the form of video files, podcasts, and narrated PowerPoint presentations, developed by the Virtual Faculty. The materials will be shared with participants at a rate of two files per week over a four-week period.In the physical self-care domain, the training will focus on regular sleep, timely screening, exercise, proper medication use, and healthy nutrition, with the aim of improving the overall well-being of patients.In the emotional self-care domain, which emphasizes the recognition and processing of emotions in a healthy manner, the goal is to support patients in coping more effectively with life challenges, enhancing resilience, and fostering self-compassion. Topics include mindfulness, journaling, establishing healthy boundaries, and improving emotional communication.In the social self-care domain, with the aim of strengthening the sense of belonging, participants will receive training in areas such as joining groups and associations, active listening, and communication management.In the psychological self-care domain, targeting mental health promotion, the educational content will cover stress management, anger management, positive thinking, and goal setting.For each domain, four video files will be prepared by a specialist and shared with participants through the virtual network. After the four-week intervention, the questionnaires will again be distributed by the researcher to both the intervention and control groups, and the data will be collected for analysis. Control group: Participants in the control group, after completing the baseline questionnaires, will continue to receive their usual care, such as visits with a psychologist or psychiatrist, if these services are already part of their routine treatment plan. At the end of the intervention period, the post-test questionnaires will be distributed to them via an online link. After data collection is completed, the educational materials provided to the intervention group will also be made available to the control group. Care self-efficacy. Timepoint: Pre-intervention and immediately post-intervention. Method of measurement: Questionnaire for Assessing Care Self-Efficacy in Adolescents with Mental Disorders. Shiraz University of Medical Sciences Approved 2024-06-01 Ethics committee of Shiraz University of Medical Sciences Shiraz, Namazi Square, Entrance of Namazi Hospital, Faculty of Nursing and Midwifery, Hazrat Fatemeh(S) Shiraz Fars Iran (Islamic Republic of)