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IRCT20150713023190N14 IRCT 2023-07-22 Rafsanjan University of Medical Sciences The effect of breathing yoga “Bhramary Pranayama” on fatigue and depression in patients with multiple sclerosis Investigation the effect of breathing yoga “Bhramary Pranayama” on fatigue and depression in patients with multiple sclerosis 2023-07-01 anticipated 80 Complete https://irct.ir/trial/70708 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as scores from fatigue severity scale and depression questionnaires. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables. The variables will stratify according to the following table : Variables Category Intervention group Control group Depression questionnaire score 14-19 20-28 29-63 Fatigue Severity Scale (FSS) questionnaire score 36-49 50-63. 2-3 Multiple Sclerosis. Intervention 1: Intervention group: For 4 weeks, they will do Bramari Pranayama yoga twice a day (morning and evening) for 20 minutes each time. In the Bramari Pranayama, the participants will sit in a comfortable position with eyes closed and will instructed to close both ears using their index fingers. The subjects will instructed to concentrate on their breathing pattern and maximum inhalation through both the nostrils followed by maximum exhalation. During exhalation, the subject will asked to chant the word “Mmmm” in such a way that the humming bee sound brought vibration in their laryngeal walls. Intervention 2: Control group: Will receive the usual care (Medical, pharmaceutical and financial support, recreational programs) of the M.S association. 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 Confidentiality of data
public Tabandeh Sadeghi
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences scientific Tabandeh Sadeghi
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 0098 34 342555900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Having relapsing-remitting M.S EDSS score less than 4 Age between 18-60 years old Confirmation of M.S by a neurologist Getting a score above 36 from the FSS questionnaire Getting a score above 14 from Beck questionnaire Ability to do yoga independently 18 years 60 years Both Having other neurological diseases except M.S Suffering from other diseases such as cancer, autoimmune diseases and cognitive problems. Use of drugs or alcohol G35 Multiple sclerosis Treatment - Other Treatment - Other Intervention group: For 4 weeks, they will do Bramari Pranayama yoga twice a day (morning and evening) for 20 minutes each time. In the Bramari Pranayama, the participants will sit in a comfortable position with eyes closed and will instructed to close both ears using their index fingers. The subjects will instructed to concentrate on their breathing pattern and maximum inhalation through both the nostrils followed by maximum exhalation. During exhalation, the subject will asked to chant the word “Mmmm” in such a way that the humming bee sound brought vibration in their laryngeal walls. Control group: Will receive the usual care (Medical, pharmaceutical and financial support, recreational programs) of the M.S association. Fatigue. Timepoint: Before the intervention and 28 days after the intervention. Method of measurement: Fatigue Severity Scale. Depression. Timepoint: Before the intervention and 28 days after the intervention. Method of measurement: Beck Depression Scale. Rafsanjan University of Medical Sciences Approved 2023-06-14 Ethics Committee of Rafsanjan University of Medical Sciences Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)