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IRCT20241113063699N1 IRCT 2024-11-20 Mashhad University of Medical Sciences Investigating the effects of mindfulness-based stress reduction (MBSR) in groups and online setting on the severity of pemphigus vulgaris disease and treatment compliance in patients with pemphigus vulgaris Investigating the effects of mindfulness-based stress reduction (MBSR) in groups and online setting on the severity of pemphigus vulgaris disease and treatment compliance in patients with pemphigus vulgaris 2024-12-11 anticipated 26 Complete https://irct.ir/trial/80222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Patients are randomly assigned to two groups: intervention and control. They are randomly allocated (using random blocks) to either the intervention or control group (via the Sealed Envelope website). The assigned codes (A/B) are written separately on pieces of paper, which are folded in a way that prevents the code from being visible (allocation concealment). It is important to note that, with the enrollment of each eligible patient and after obtaining informed consent, one piece of paper is randomly selected, and based on the code inside (A/B), the patient is placed in either the intervention or control group, Blinding description: control group. Randomization is carried out through a randomization system (for example, using the Sealed Envelope website), where the allocations are written as concealed codes (A/B). The allocation codes (A/B) are written on separate pieces of paper, which are then folded and kept concealed from the researchers. These papers are randomly drawn from the envelope by the researchers, and based on the code inside, the patient is assigned to either the intervention or control group. Patients are unaware of which group (intervention or control) they belong to. They only know that they are receiving an intervention or treatment but are not informed of which specific treatment group they are in. Those assessing the outcomes, such as disease severity or treatment compliance, do not know which group the patient belongs to. This ensures that the evaluations are carried out impartially and without any preconceived bias. 2-3 Pemphigus Vulgaris. Intervention 1: Intervention group: week program, with one 90-minute online session per week, conducted in groups of five participants. These sessions will be led by a psychiatry resident trained in Mindfulness-Based Stress Reduction (MBSR) and supervised by the relevant instructor. Intervention 2: Control group: session providing necessary education on pemphigus vulgaris, its symptoms, disease progression, both pharmacological and non-pharmacological treatments, required care, and follow-up procedures. This session will be conducted based on the dermatologist’s advice and will include answering the patient’s questions. 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 Zahra Ghaseminejad
Ebne sina Psychiatric Hospital Mashhad, Hor Ameli North Street
Mashhad Iran (Islamic Republic of) 9183665411 +98 51 3844 5600 Zahraghaseminejad1372@gmail.com Mashhad University of Medical Sciences scientific Zahra Ghaseminejad
Ebne sina Psychiatric Hospital Mashhad, Hor Ameli North Street
Mashhad Iran (Islamic Republic of) 9183665411 +98 51 3844 5600 Zahraghaseminejad1372@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Pemphigus Vulgaris Based on Clinical Examination and Cytopathological Evaluation Age Range: 20 to 60 Years Minimum Education: At least a middle school diploma A score above 8 on the stress scale and a score above 15 on the anxiety scale of the DASS-21 questionnaire No current or past history of major psychiatric disorders Consent to participate in the study and completion of the informed consent form 20 years 60 years Both Absence of more than two sessions. L10.0 Pemphigus vulgaris Lifestyle Lifestyle Intervention group: week program, with one 90-minute online session per week, conducted in groups of five participants. These sessions will be led by a psychiatry resident trained in Mindfulness-Based Stress Reduction (MBSR) and supervised by the relevant instructor Control group: session providing necessary education on pemphigus vulgaris, its symptoms, disease progression, both pharmacological and non-pharmacological treatments, required care, and follow-up procedures. This session will be conducted based on the dermatologist’s advice and will include answering the patient’s questions. Morisky Medication Adherence Scale score. Timepoint: Before the intervention and 4 weeks after the completion of the intervention. Method of measurement: Morisky Medication Adherence Scale. Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) score. Timepoint: Before the intervention and 4 weeks after the completion of the intervention. Method of measurement: Depression, Anxiety, and Stress Scale - 21 Items (DASS-21). Mashhad University of Medical Sciences Approved 2024-09-17 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences School of Medicine, University pardis, Eastern Entrance at Azadi Square, Kalantari Highway, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)