The Effect of Orem-Based Education on Care Self-Efficacy in Adolescents Engaging in Non-Suicidal Self-Injury
Design
This is a parallel-group, randomized controlled clinical trial with 36 patients. Randomization is performed using SPSS software.
Settings and conduct
Participants were recruited through Ibn Sina Hospital and Imam Reza Clinic and were randomly assigned to the intervention and control groups. Links to the questionnaires were sent to all participants before and after the study. The intervention group received educational content tailored to their physical, social, emotional, and psychological needs in the form of audio and video materials delivered via a social media platform. The control group continued their usual psychological treatments, if any, during the study period and received the educational materials after completion of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
History of self-injurious behavior
Living with parents
Willingness to participate in the study
Parental consent for adolescent participation in the study
Exclusion criteria:
Presence of Psychotic Disorders in the Adolescent.
Intervention groups
The intervention group consisted of 18 adolescents with self-injurious behavior who received Orem-based self-care intervention tailored to their physical, social, emotional, and psychological needs. The control group included 18 adolescents with self-injurious behavior who continued their usual psychological treatments, if any, during the intervention period, and were provided with the educational materials after completion of the study.
Main outcome variables
Caring self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250810066806N1
Registration date:2025-08-24, 1404/06/02
Registration timing:registered_while_recruiting
Last update:2025-08-24, 1404/06/02
Update count:0
Registration date
2025-08-24, 1404/06/02
Registrant information
Name
Elham Mirshah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3738 3895
Email address
mirshah70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2025-09-11, 1404/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Orem-Based Education on the Care Self-Efficacy of Adolescents Engaging in Non-Suicidal Self-Injury
Public title
The Effect of Education on the Care Self-Efficacy of Adolescents Engaging in Non-Suicidal Self-Injury
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
History of Self-Injury Behavior
Living with Parents
Willingness to Participate in the Study
Parental Consent for the Adolescent’s Participation in the Study
Exclusion criteria:
Presence of Psychotic Disorders in the Adolescent
Age
From 11 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Namazi Square, Entrance of Namazi Hospital, Faculty of Nursing and Midwifery, Hazrat Fatemeh(S)
City
Shiraz
Province
Fars
Postal code
۱۳۱۱۹ - ۷۱۹۳۶
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1403.052
Health conditions studied
1
Description of health condition studied
Self-injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Care self-efficacy
Timepoint
Pre-intervention and immediately post-intervention
Method of measurement
Questionnaire for Assessing Care Self-Efficacy in Adolescents with Mental Disorders
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Lifestyle
2
Description
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.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital
Full name of responsible person
Shahrzad Yektatalab
Street address
Hafez St., Ibn-e-Sina Hospital
City
Shiraz
Province
Fars
Postal code
71466-76541
Phone
+98 71 3228 9601
Email
sinahosp@sums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Shahrzad Yektatalab
Street address
Imam Reza Specialized and Subspecialized Clinic, next to Namazi Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14734
Phone
+98 71 3212 7000
Email
emamreza@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, opposite Palestine Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, at the entrance of Namazi Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
nurs_midwif@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahrzad Yektatalab
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, at the entrance of Namazi Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
nurs_midwif@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Mirshah
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, at the entrance of Namazi Hospital, Namazi Square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
mirshah70@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 data will become available and for how long
The access period begins six months after the publication of the results.
To whom data/document is available
Researchers affiliated with scientific institutes and universities
Under which criteria data/document could be used
The data can be utilized for longitudinal and retrospective research purposes.
From where data/document is obtainable
Elham Mirshah
Email: mirshah70@gmail.com
Hazrat Fatemeh (S) Faculty of Nursing and Midwifery, Namazi Square, Shiraz, Iran
What processes are involved for a request to access data/document
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.