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IRCT20201004048920N1 IRCT 2020-11-18 The University of Semnan Effectiveness of mindfulness-based cognitive therapy separately and combined with TDCS (device treatment) on Worry, Emotion regulation, Pain severity and quality of life in Chronic muscle pain patients. Effectiveness of mindfulness-based cognitive therapy separately and combined with TDCS on Worry, Emotion regulation, Pain severity and quality of life in Fibromyalgia patients 2020-10-11 anticipated 48 Complete https://irct.ir/trial/51434 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used. unit of randomization: individual. randomization tool: random number table. A random number table is a series of digits (0 to 9) arranged randomly in rows and columns. The table usually contains 5-digit numbers, arranged in rows and columns, for ease of reading. Typically, a full table may extend over as many as four or more pages. we have a population of 48 patients and each patient has been assigned a number from 1 to 48. we wish to sample 12 patients to out for each group. Since 48 is a two-digit number, we need to use the first two digits of the numbers listed on the random table. We close our eyes and randomly point to a spot on the table. For this example, we will assume that we selected 50631 in the first column. We interpret that number as 50 (first two digits). Since we don’t have a member of our population with that number, we go down to the next number 29 (29990). We choose this number as 1st sample for first group. Continuing down the chart to select other 11 subjects for the first group. After completing the first group, start this procedure to select next 12 samples for the next group and in this way, we select members of all four sample groups. (during this process, we will ignore duplicate numbers). N/A Fibromyalgia. Intervention 1: Intervention group: Mindfulness-Based Cognitive Therapy (MBCT): Accomplished in groups of 12 people in 2 hours sessions per week. (2 sessions per week) during 1 month on 12 patients. Training includes both formal exercises (e.g. body checkout, sitting meditation, walking meditation and yoga) and informal exercises (such as bringing present awareness to daily activities), Cognitive - behavioral technics such as education, activity supervision and planning, negative spontaneous thoughts recognition and planning response prevention program. Intervention 2: Intervention group: 8 Sessions tDCS treatment (3 sessions per week). 20 minutes each session. During treatment sessions, cathode electrode will be placed at FP2 area and anode electrode at F3 area. 2mA current will be used. Intervention 3: Intervention group: Combination group (MBCT and tDCS). Intervention 4: Control group: Receive artificial stimulation: Electrode will be placed on patient's head. but as soon as sense of irritation, the device will be turned off and he/she will not receive any stimulation. 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 more information
public Maryam Akbarzadeh
Darband, Mahdishahr
Semnan Iran (Islamic Republic of) 3564111556 +98 23 3362 4250 m_akbarzadeh66@yahoo.com The University of Semnan scientific Maryam Akbarzadeh
Darband, Mahdishahr
Semnan Iran (Islamic Republic of) 3564111556 +98 23 3362 4250 m_akbarzadeh66@yahoo.com The University of Semnan Iran (Islamic Republic of) Fibromyalgia disorder. Pain period: at least 6 months. Pain is not related to another disease such as cancer or MS. Ability to attend treatment sessions and not attended in any psychological treatment program during last 6 months 30 years 55 years Both suffering from a Rheumatologic or acute psychological disorder which lead to pain. have past epilepsy, seizure disease, Traumatic Brain Injury, brain tumor and brain implant and Mental retardation. Acute heart patients using drug pump. Pregnant people. Substance abuse and addicted patients. M79.7 Fibromyalgia Treatment - Other Treatment - Devices Treatment - Other Treatment - Other Intervention group: Mindfulness-Based Cognitive Therapy (MBCT): Accomplished in groups of 12 people in 2 hours sessions per week. (2 sessions per week) during 1 month on 12 patients. Training includes both formal exercises (e.g. body checkout, sitting meditation, walking meditation and yoga) and informal exercises (such as bringing present awareness to daily activities), Cognitive - behavioral technics such as education, activity supervision and planning, negative spontaneous thoughts recognition and planning response prevention program. Intervention group: 8 Sessions tDCS treatment (3 sessions per week). 20 minutes each session. During treatment sessions, cathode electrode will be placed at FP2 area and anode electrode at F3 area. 2mA current will be used. Intervention group: Combination group (MBCT and tDCS) Control group: Receive artificial stimulation: Electrode will be placed on patient's head. but as soon as sense of irritation, the device will be turned off and he/she will not receive any stimulation. Worry. Timepoint: Before treatment, Maximum a week after treatment, two months after treatment. Method of measurement: Pennsylvania State Worry Questionnaire. Emotion regulation. Timepoint: Before treatment, Maximum a week after treatment, two months after treatment. Method of measurement: Cognitive Emotion Regulation Questionnaire. Pain severity. Timepoint: Before treatment, Maximum a week after treatment, two months after treatment. Method of measurement: Short-form McGill Pain Questionnaire. Quality of life. Timepoint: Before treatment, Maximum a week after treatment, two months after treatment. Method of measurement: Short-Form 36 (SF-36) questionnaire. The University of Semnan Approved 2020-09-22 Ethics committee of Semnan University of Medical Sciences Darband Blvd., Mahdishahr. Semnan Semnan Iran (Islamic Republic of)