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IRCT20251108067908N1 IRCT 2025-11-15 Tarbiat Modares University Investigating the effect of application-based education on preventive behaviors against pediculosis infection in students Investigating the effect of application-based education on preventive behaviors against pediculosis infection in students 2025-12-06 anticipated 90 Complete https://irct.ir/trial/87354 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Education/Guidance, Randomization description: In this study, stratified cluster randomization was used. The school was considered the unit of randomization to prevent the transfer and exchange of information between students of different groups. For this purpose, first, a list of primary girls' schools in Aliabad Katul city was received from the Education Department. Then, the schools were divided into two classes, east and west of the city, based on geographical location, to ensure a balanced geographical distribution of the samples. In each class, two schools that had similar conditions in terms of the number of students, socio-economic level, and willingness to cooperate with the research were selected; a total of four schools were included in the study. In each class (east and west), schools were randomly assigned to the intervention and control groups. For this purpose, Excel software and the RAND function were used to generate random numbers. Each school was assigned a random number, and the school with the smaller number was designated as the intervention group (app-based education) and the other school as the control group (regular school education). The random sequence generation process was performed by a research associate who was unaware of the purpose of the study and the nature of the groups. The file containing the random sequence was stored in encrypted form and was unchangeable after finalization. To maintain allocation concealment, the randomization results were kept in sealed, coded envelopes. Until the pretest was completed at each school, none of the research team members were aware of the school allocation type. After the pretest was completed, the envelope for each school was opened and the group type was determined. This process helped maintain impartiality in data collection and prevent allocation bias. N/A Pediculosis. Intervention group: Intervention group: Students in this group received training based on the pediculosis educational app. The content of the app included: short educational videos infographics health tips, preventive behaviors and early detection methods interactive activities and questions. Students used the app with their parents for a specific period of time and had full access to all educational sections. No pharmaceuticals or therapeutic interventions were provided and only structured e-learning was implemented.. Yes - There is a plan to make this available What will be shared: In this study, individual participant data files including knowledge scores, health model constructs, and preventive behaviors were collected at three time points. These data are available for sharing after removing any identifiable information (fully de-identified). Sharing will only include data related to the main study outcomes and will not release identifying information, school details, or any other sensitive data. When: De-identified study data will be available 6 months after the publication of the final research results. The data access period will continue for at least three years after the date of publication of the results. To whom: De-identified study data will be available to researchers and university faculty members. Applicants must have a valid institutional affiliation and provide a clear research objective. Data will not be available to individuals outside of academic and research settings—including industry. Conditions: The conditions for use and access to de-identified data are as follows: Submission of a formal request including the title of the research, the purpose of using the data, and the type of analyses desired. Use only for research and non-commercial purposes; any commercial or promotional use is prohibited. Permitted analyses are limited to statistical analyses related to the scientific purposes specified in the request; analyses that lead to the inference of the identity of individuals are strictly prohibited. No re-sharing of data with other individuals or organizations without written permission. Use of data in accordance with the principles of research ethics and with full confidentiality. Appropriate citation to the original study in any scientific output (article, thesis, report, etc.). Where to obtain: Applicants can apply for de-identified data or study documentation through the following channels: 1. Email contact (mehdizaheriyotub@gmail.com Name of the responsible person: Mehdi Zaheri Niko (Principal Investigator) Email: [mehdizaheriyotub@gmail.com 2. Postal correspondence (second priority) Address: Tehran, Intersection of Jalal Al-Ahmad and Chamran Highways, Tarbiat Modares University, Postal Code: 1411713116, P.O. Box: 111-1 3. Telephone call (third priority) Contact number: [09051436545] In the submitted request, the following information must be provided: Research title, purpose of data use, proposed type of analysis, applicant's organizational affiliation, and confidentiality agreement. How to obtain: The process of receiving data is step-by-step and transparent as follows: Submitting a formal request The applicant must send their request along with the title of the study, purpose of use, type of analysis, and an institutional introduction via the principal investigator’s email. Time required: 1–2 days to register the request. Reviewing the request The request is reviewed by the principal investigator to ensure that the use of the data is consistent with ethical principles and study conditions. Time required: approximately 7–10 business days. Sending a confidentiality undertaking In case of initial approval, the applicant will be sent a confidentiality and non-sharing undertaking form that must be completed and signed. Time required: 3–5 days (depending on the speed of return of the form). Final approval and data preparation After receiving the signed undertaking, the de-identified data are prepared and reviewed for final review. Time required: 5–7 business days. Sending data to the applicant Files will be provided to the applicant via email or secure storage. Estimated total time to receive data: Approximately 2-4 weeks from the time of initial request to final delivery of data. Comments:
public Fadlallah Ghafranipour
Intersection of Jalal Al-Ahmad and Chamran Highways, Tarbiat Modares University
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 8288 2009 ghofranf@modares.ac.ir Tarbiat Modares University scientific Hassan Shahbazi
Intersection of Jalal Al-Ahmad and Chamran Highways, Tarbiat Modares University
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۱۶ +98 21 8288 2009 h.shahbazi@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Female students in grades four to six of elementary school in Aliabad Katul County Written consent from the student and parents to participate in the research Access to a mobile phone or tablet to use the educational app (with parental supervision) Not having chronic diseases or specific physical conditions that prevent participation in training No history of pediculosis or active treatment within one month prior to the start of the study. 10 years 12 years Female Lack of written consent from students and parents to participate in the research Having chronic illnesses or specific physical conditions that prevent participation in training Having a history of pediculosis or active treatment within one month prior to the start of the study Lack of access to a mobile phone or tablet to use an educational app (with parental supervision) Female students other than fourth to sixth graders of primary school in Aliabad Katul County B85.0 Pediculosis due to Pediculus humanus capitis Prevention Intervention group: Intervention group: Students in this group received training based on the pediculosis educational app. The content of the app included: short educational videos infographics health tips, preventive behaviors and early detection methods interactive activities and questions. Students used the app with their parents for a specific period of time and had full access to all educational sections. No pharmaceuticals or therapeutic interventions were provided and only structured e-learning was implemented. In this study, the pediculosis preventive behaviors score was considered as the primary outcome variable. This variable was measured using the Pediculosis Prevention Behaviors Questionnaire in three stages (before, immediately, and three months after the intervention) and was used as the basis for determining the study sample size. Timepoint: The primary outcome variable (prevention behavior score) is measured at three time points:Pretest — before the intervention begins (before training).Immediate posttest — immediately after the end of the training program (up to one week after the end of the intervention).Three-month follow-up — three months after the end of the intervention (approximately 90 days after the end).Each measurement is made with the same prevention behavior questionnaire and is used to analyze changes between these time points. Method of measurement: The primary outcome variable, the pediculosis preventive behaviors score, was measured using the Pediculosis Prevention Behaviors Questionnaire. This questionnaire includes a set of standard items about health behaviors related to pediculosis prevention and was completed by students at all three time points. Tarbiat Modares University Approved 2025-11-15 Research Ethics Committee of Tarbiat Modares University Intersection of Jalal Al-Ahmad and Chamran Highways, Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)