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IRCT20230511058152N1 IRCT 2023-05-19 Mashhad University of Medical Sciences Investigating The Effect Of Physical Activity On Adolescents With Juvenile Idiopathic Arthritis Investigating The Effect Of Using Smartphone-Based Home Physical Activity On the level of Anxiety and Depression Of Adolescents With Juvenile Idiopathic Arthritis 2023-06-22 anticipated 60 Complete https://irct.ir/trial/70096 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done in a Simple Way. Randomization Tool: https://www.Randomization.com The Randomization Website Will be Used to Perform Simple Randomization. The System Completely Impartially Assigns the Samples to Two Control and Intervention Groups, Blinding description: In this study, blinding has been done for the data analyst. They are unaware of which group each sample belongs to. After randomization, the participants will be informed which group they are in and what intervention they will receive. The main researcher of the project is also fully aware of which group the patients belong to. The sports doctor and the rheumatologist of the patients are also aware of the grouping of the patients. N/A Juvenile idiopathic arthritis. Intervention 1: Intervention group: In addition to routine care, people in the intervention group will receive a home exercise program based on a smartphone in the context of a sports application. This program uses a pre-designed application called "Sworkit Kids". Teenagers who have received permission to enter the program from their rheumatologist will be visited individually by a sports doctor in the presence of the researcher. For every teenager, a suitable exercise regime will be prepared and adjusted, including the type of movements, the number and time required for each movement. The application suitable for each patient's exercise regimen is adjusted by the researcher and installed on the patient's smartphone, and how to work with it is taught. Finally, after 8 weeks of intervention, depression and anxiety questionnaires will be completed again by both the intervention and control groups. Intervention 2: Control group: People in this group will receive routine care including drug care, physical therapy and diet. Yes - There is a plan to make this available What will be shared: After publishing the results of the research and completing the evaluations, the data of the research, including the level of anxiety and depression in adolescents with idiopathic arthritis of the youth before the intervention and also its changes after the intervention, the difference in the levels of depression and anxiety in male and female patients, the level of adherence to physical activities in Patients with chronic diseases will be published without mentioning the patient's profile. When: After the end of the study, all the medical data of the patients can be shared. To whom: Researchers working in academic, scientific and industrial institutions Conditions: Other than the main researcher, no one is allowed to use the documents. Where to obtain: The desired request should be sent to Ms. Mitra Gholami's email: gholamimt3@mums.ac.ir How to obtain: The desired request should be sent to Ms. Mitra Gholami's email: gholamimt3@mums.ac.ir Comments:
public Mitra Gholami
School of Nursing and Midwifery, Ibn Sina St, Doctor's Crossroads, Daneshgah St. Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9137913199 00985138591511 051 gholamimt3@mums.ac.ir Mashhad University of Medical Sciences scientific Mitra Gholami
School of Nursing and Midwifery, Ibn Sina St, Doctor's Crossroads, Daneshgah St. Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9137913199 00985138591511 051 gholamimt3@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients Should be in the Age Range of 12-18 Years. Declare the Consent of Adolescents and their Parents Patients should not be in the Acute Phase of the Disease. Patients have less than 5 Joints Involved. A Smart Mobile Phone with at least Android 4.0 and the Ability to Use It. Do not have other Underlying Diseases, Including Cardiovascular, Neurological, and Musculoskeletal diseases. Have Permission to Exercise and Physical Activity from a Rheumatologist. Having Access to the Internet Obtaining a Score less than 20 from the CDI Questionnaire and less than 78 from the MASC Questionnaire in the Initial Screening 12 years 18 years Both Parents or adolescents do not agree to participate in the study. Intolerance of exercises do to severe pain M08 Juvenile arthritis Rehabilitation N/A Intervention group: In addition to routine care, people in the intervention group will receive a home exercise program based on a smartphone in the context of a sports application. This program uses a pre-designed application called "Sworkit Kids". Teenagers who have received permission to enter the program from their rheumatologist will be visited individually by a sports doctor in the presence of the researcher. For every teenager, a suitable exercise regime will be prepared and adjusted, including the type of movements, the number and time required for each movement. The application suitable for each patient's exercise regimen is adjusted by the researcher and installed on the patient's smartphone, and how to work with it is taught. Finally, after 8 weeks of intervention, depression and anxiety questionnaires will be completed again by both the intervention and control groups. Control group: People in this group will receive routine care including drug care, physical therapy and diet. The anxiety score is checked using the Multidimensional Anxiety Scale for Children questionnaire, which includes a total of 39 questions in 4 dimensions of anxiety. The scoring range in this questionnaire is 0 to 117. With the increase in the score, the degree of anxiety disorder will be more likely. Timepoint: Baseline phase and also with the purpose of screening and then after 8 weeks of intervention. Method of measurement: Multidimensional Anxiety Scale for Children questionnaire. The depression score is evaluated using the Children's Depression Inventory questionnaire, which includes 27 items. By answering them, the subject gets a score between 0 and 54. The higher this number, the higher the level of depression. Timepoint: Baseline phase and also with the purpose of screening and then after 8 weeks of intervention. Method of measurement: Children's Depression Inventory questionnaire. Mashhad University of Medical Sciences Approved 2023-04-11 Ethics Committee of Mashhad University of Medical Sciences Vice President of Research and Technology, Qurashi building, Next to Hoveizeh cinema, Daneshgah St Mashhad Razavi Khorasan Iran (Islamic Republic of)