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IRCT20191229045933N1 IRCT 2021-03-19 Trabiat Modares University Effect of a patient decision aid to select for myopia correction surgery method Design, implementation, and evaluation of educational intervention through the patient decision making aid (PDA) to select correction method for patients with myopia 2021-04-04 anticipated 30 Complete https://irct.ir/trial/44617 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the block (quadruple) randomization method will be performed. Thus, by referring to the hospital, the researcher identifies the eligible individuals to participate in the study and divides them into two experimental and control groups by random allocation by quadruple block method. It considers the letter A for the intervention group and the letter B for the control group. Then all the permutation combinations of the letters AA and BB, which are six different combinations, and from combinations 1 to 6, one combination is randomly selected. This operation continues continuously until the sample size is reached. N/A Myopia. Intervention 1: Intervention group: The intervention includes three phases: pre-test, content training, and post-test. The test is sent to their mobile phone in the form of an online questionnaire including assessment of feelings, knowledge and decision stage. The link of the website designed for the patients of the intervention group, i.e. the patients who are candidates for three surgical methods, will be sent and the way of working with the tool will be explained to the people. Each person has access to educational content for 48 hours at any time and place. At the end of 48 hours, access to the educational content is automatically disabled. At the end of the process of using the tool, pre-test questions are asked again. Intervention 2: Control group: The test is sent to their mobile phone in the form of an online questionnaire including evaluation of feelings, knowledge and decision stage. This group does not receive any training. At the end of the educational intervention, they receive a post-test questionnaire. Yes - There is a plan to make this available What will be shared: Part of the data on the main consequences can be shared. When: Access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Frequent measurement analysis to evaluate the effect of education and patient decision, 6 months after the intervention Where to obtain: By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir How to obtain: One week after sending the email by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered. Comments:
public Fatemeh Zarei
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
Tehran Iran (Islamic Republic of) 14115111 +98 21 8288 4546 f.zarei@modares.ac.ir TehranTarbiat Modares University scientific Fatemeh Zarei
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
Tehran Iran (Islamic Republic of) 14115111 +98 21 8288 4546 f.zarei@modares.ac.ir TehranTarbiat Modares University Iran (Islamic Republic of) All patient with enough vision for reviewing the decision aid content All Patient with enough literacy for reviewing the decision aid content All Nearsighted patient proved by ophthalmologist and optometrist Candidates for all three surgical procedures: Smile, Femto-LASIK and PRK 15 years 40 years Both Patients have not received formal education on myopia correction H52.13 Myopia, bilateral N/A N/A Intervention group: The intervention includes three phases: pre-test, content training, and post-test. The test is sent to their mobile phone in the form of an online questionnaire including assessment of feelings, knowledge and decision stage. The link of the website designed for the patients of the intervention group, i.e. the patients who are candidates for three surgical methods, will be sent and the way of working with the tool will be explained to the people. Each person has access to educational content for 48 hours at any time and place. At the end of 48 hours, access to the educational content is automatically disabled. At the end of the process of using the tool, pre-test questions are asked again. Control group: The test is sent to their mobile phone in the form of an online questionnaire including evaluation of feelings, knowledge and decision stage. This group does not receive any training. At the end of the educational intervention, they receive a post-test questionnaire. Knowledge of laser correction methods for myopia. Timepoint: 48 after educational intervention. Method of measurement: Through knowledge assessment questions about the three eye surgery methods listed in the patient decision aid. The patient's decision in choosing the method of laser surgery for myopia. Timepoint: 48 after educational intervention. Method of measurement: From the decision assessment questions of choosing the surgical method, contained in the patient decision aid. Tehran University of Medical Sciences Trabiat Modares University Tehran University of Medical Sciences Approved 2019-11-27 Trabiat Modares University Jalal Al-Ahmad St., Nasr Bridge, Tarbiat Modares University, School of Medicine Tehran Tehran Iran (Islamic Republic of)