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IRCT20220703055351N3 IRCT 2024-02-11 Arak University of Medical Sciences The effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and illness Perception in women with multiple sclerosis The effect of training based on Leventhal's self-regulation model on anxiety, stress, depression and illness Perception in women with multiple sclerosis 2024-02-19 anticipated 64 Complete https://irct.ir/trial/74935 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, random blocks will be used in order to conceal the randomized allocation of concealment and balance during and after the study. For this purpose, the site sealedenvelope is used. The total sample size, the number of studied groups, and the number of blocks in question (blocks of 4) will be entered on the mentioned site, and its output will be a randomized list including the number of samples separated by the studied groups (control and intervention). Then, the eligible research samples will be selected and based on the priority of reference, each of them will be assigned a code, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to theintervention group and the control group. N/A Multiple sclerosis. Intervention 1: Intervention group: In addition to routine training, people in the intervention group will receive self-regulation training based on the Levantal model in four to five offline sessions through virtual networks as a group and two to three online sessions through Skype as a group. did Each offline session will be multimedia and average 20 minutes, and each online session will be lecture and average 15 minutes. All sessions will be designed based on the two cognitive and emotional dimensions of Leventhal's self-regulation model and will be designed within 5 weeks. Intervention 2: Control group: Only the usual training provided by the clinic's treatment staff is received. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no further information".
public Mahsa Hosseini
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3503 smahsahosseini99@gmail.com Arak University of Medical Sciences scientific mahsa hosseini
Arak,Arak University of Medical Sciences,Basij Square, Shazand Boulevard
Arak Iran (Islamic Republic of) smahsahosseini99@gma +98 86 3221 9498 mahsahoseiny2018@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Examination of the disease based on the medical record and expert diagnosis Age between 18-50 years A history of illness of at least one year Access to a smartphone and having media literacy (ability to work with a smartphone) Not being in the relapse stage Not suffering from any other acute or chronic disease based on self-report and medical record, ability to speak (speech and hearing) Not having dementia and known mental disorders based on the person's statements and medical record Patients should not receive other education related to methods of dealing with stress, anxiety and depression Minimum literacy Obtaining a score of 0-5.5 on the Extended Disability Status Scale Not suffering from other autoimmune diseases (psoriasis, myasthenia gravis) Not suffering from neurological diseases (Parkinson, epilepsy) 18 years 50 years Female Inability of the patient to continue participating in the research for any reason (accident, death or migration to another city) Unwillingness to continue cooperation pregnancy drug use Physical limitations Making specific changes during the study in people's lifestyle or treatment process G35 Multiple sclerosis Other Other Intervention group: In addition to routine training, people in the intervention group will receive self-regulation training based on the Levantal model in four to five offline sessions through virtual networks as a group and two to three online sessions through Skype as a group. did Each offline session will be multimedia and average 20 minutes, and each online session will be lecture and average 15 minutes. All sessions will be designed based on the two cognitive and emotional dimensions of Leventhal's self-regulation model and will be designed within 5 weeks. Control group: Only the usual training provided by the clinic's treatment staff is received. Stress is one of the consequences of MS. Timepoint: Once before the intervention, once immediately after the intervention, four weeks after the intervention. Method of measurement: stress, anxiety and depression questionnaire. Anxiety is one of the consequences of MS. Timepoint: Once before the intervention, once immediately after the intervention, four weeks after the intervention. Method of measurement: stress, anxiety and depression questionnaire. Depression is one of the consequences of MS. Timepoint: Once before the intervention, once immediately after the intervention, four weeks after the intervention. Method of measurement: stress, anxiety and depression questionnaire. The understanding of the disease is the influencing factor on how patients deal with their disease. Timepoint: Once before the intervention, once immediately after the intervention, four weeks after the intervention. Method of measurement: Brief Illness Perception Questionnaire. Arak University of Medical Sciences Approved 2024-01-10 Research Ethics Committees of Arak University of Medical Sciences Malek St.Arak Arak Markazi Iran (Islamic Republic of)