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IRCT20191021045178N4 IRCT 2021-06-15 Shiraz University of Medical Sciences The effect of self-management program on quality of life, health status and self-management of scleroderma patients The effect of self-management intervention on quality of life, health status and self-management in patients with scleroderma 2021-09-23 anticipated 60 Complete https://irct.ir/trial/56731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, first, according to the list of patients in the clinic, a list of patients who meet the inclusion criteria is determined. Then sampling will be done by systematic random method. Select the appropriate distance (k) and select the names at equal intervals along the list. The distance or k is obtained by dividing the number of members of the study population by the number of members in the sample. It should be noted that the starting point for this regular selection process is random and is done from a table of random numbers. To include people in the study as an example. Then, using blocking software, people will be randomly placed in two blocks, A and B. Using this method, the number of people assigned to each block will be equal. Finally, by tossing coins, each block will be placed in two groups of control and intervention, Blinding description: To blind the study, participants are given a full explanation of how to perform the intervention before the intervention, but participants are unaware of the allocation of study groups. Also, in collecting data and completing questionnaires, the help of a researcher who is not aware of the division of groups will be used. Also, the statistician who analyzes the data will not know about the allocation of groups. N/A Self-managment. Intervention 1: Intervention group: Self-management education program-Get routine care. Intervention 2: Control group: Get routine care. Yes - There is a plan to make this available What will be shared: Providing information without personal details of the participants will be confidential When: After studying and printing the results To whom: The results of the research will be provided to the participants and relevant organizations upon request. Conditions: Obtaining permission from the relevant authorities in the faculty, university and hospital. Keeping participants' information confidential Where to obtain: Shiraz. Zand St., Library of Shiraz School of Nursing and Midwifery How to obtain: The request for the results will be sent to the library of Shiraz School of Nursing and Midwifery. It will be provided to them with the coordination done. Comments:
public Niloofar Pasyar
زند، روبروی خیابان فلسطین، ساختمان مرکزی دانشگاه علوم پزشکی شیراز
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3212 2713 pasyarn@yahoo.com Shiraz University of Medical Sciences scientific Niloofar Pasyar
Shiraz, Namazi Square, Hazrat Fatemeh School of Nursing
Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3647 4254 Npasyar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 1. Patients referred to the rheumatology department and rheumatology clinic with a definite medical diagnosis of scleroderma.2. Patients who have been diagnosed with scleroderma for one year and have sufficient experience of the details and problems of the disease3. Have the desired physical, mental and cognitive ability to participate in research.4. Be able to express and speak in Persian.5. People who want to participate in the study. no limit no limit Both 1. If they do not want to continue cooperation at any stage of the research, they can be excluded from the study.2. Illness and inability of the patient to lead to hospitalization and the person is not able to continue participating in the research.3. Occurrence of any physical or mental accident during the last six months and during the study period that affects his physical and mental condition.4. Having a chronic mental illness Other Other Intervention group: Self-management education program-Get routine care Control group: Get routine care Quality of life before and after the intervention, Quality of life questionnaire score 2: Health status assessment before and after the intervention, Health status assessment questionnaire score 3: Self-management before and after the intervention, Self-management questionnaire score. Timepoint: before and after the intervention. Method of measurement: Quality of Life Questionnaire Health Status Assessment Questionnaire Self-Management Questionnaire. Quality of Life. Timepoint: Before and after the intervention. Method of measurement: Quality of life questionnaire for patients with scleroderma. General health assessment. Timepoint: Before and after the intervention. Method of measurement: Stanford General Health Scale. Self management. Timepoint: Before and after the intervention. Method of measurement: Self-efficacy questionnaire for self-management in chronic patients. Shiraz University of Medical Sciences Approved 2021-02-07 Ethics Committee of Shiraz University of Medical Sciences Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)