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IRCT20210119050079N2 IRCT 2023-02-21 Kermanshah University of Medical Sciences Examining the effectiveness of amygdala and insula retraining (AIR) program on psychological indicators and sleep patterns in fibromyalgia patients Examining the effectiveness of amygdala and insula retraining (AIR) program on psychological indicators and sleep patterns in fibromyalgia patients. 2023-02-25 anticipated 70 Complete https://irct.ir/trial/68687 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on a randomized table with 15 blocks designed using Random allocation software, patients are placed in three equal groups (1. Amygdala and Insula recovery intervention, 2. Physical activity, 3. control). In order to randomly assign 50 patients to three groups, first, 10 blocks of 5 different letters A, B, and C are created, which indicate intervention groups for amygdala and insula recovery, physical activity, and control. Then these blocks are numbered from one to ten. In the next step, each of these blocks is randomly selected by drawing 10 times from numbers one to ten. Thus, in each lottery, by choosing a block, a combination of 5 letters A, B, and C is obtained, and at the end of 10 stages of the lottery, after choosing 10 blocks, a total of 50 combinations of letters A and B are obtained, and C will be obtained from the blocks. The obtained combination of letters A, B, and C are placed one by one in 50 separate and sealed envelopes, and one envelope is opened with each patient's visit to determine which group the patient belongs to, Blinding description: Outcome examiners (people who distribute questionnaires among patients) are blind to the type of groups. N/A Fibromyalgia. Intervention 1: Intervention group: In the Amygdala and Insula recovery intervention, the hypothesis is that changing emotion and cognition is more effective when the body moves. This psychotherapy approach focuses on improving coping skills and strategies for stressful situations by supposedly interrupting conditioned anxiety or fear responses from the Amygdala. This intervention consists of behavioral and psychological techniques such as cognitive therapy, breathing, meditation and neuro-linguistic programming. The amygdala and insula recovery technique will be practiced in 8 weeks based on the table below. Intervention 2: Intervention group: The group will receive aerobic exercise in two months. The exercises will include two parts: static aerobic exercise and dynamic aerobic exercise. In general, the exercises will consist of 4 main parts. 1) warm up; It will include stretching movements, hypothetical line movements, cross-arm movements, arm rotations, neck rotations, cross-leg movements, sit-ups, 2) static aerobic exercise; Includes climbers walking, Palank, Palank with knee touch, and ski movement. 3) Dynamic aerobic exercise; It will include jogging at 70% of your maximum heart rate. 4) cooling down; It will include stretching, cross-linking, sitting, lying down and cradle movement. Exercises are performed with behavioral techniques and with the guidance of sports instructors and in a modified manner in accordance with the physical fitness of patients. The intervention will done in 8 weeks and 2 sessions per week. Patients engage in aerobic exercise for 30 to 45 minutes per session. Intervention 3: Control group: Participants in the control condition meet at least once a week at the research center and can talk about their illness and daily life. If they wish, they may also talk to nurses and doctors. No - There is not a plan to make this available Justification or reason for not sharing IPD is In order to protect the subjects' rights and keep their details confidential
public Habibolah Khazaie
Sleep Disorders Research Center, Farabi Hospital, Doulatabad Blvd., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 1824 9353 hakhazaie@gmail.com Kermanshah University of Medical Sciences scientific Habibolah Khazaie
Sleep Disorders Research Center, Farabi Hospital, epartment of Psychiatry, Kermanshah University of Medical Sciences, Dolatabad Blvd, PO box: 6719851151, Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6719851151 +98 83 1824 9353 hakhazaie@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 year Having an FM diagnostic in accordance with the American College of Rheumatology (ACR) 1990 criteria and provided by a rheumatologist working for the Iranian National Health Service Being able to read and understand Persian 18 years 70 years Both Presence of severe Axis I psychiatric/somatic disorder, autoimmune disease, or the use of corticosteroid medication Participation in a concurrent RCT. As long as the patients agreed not to change their medication dosage during the RCT period, they were not asked to discontinue their regular pattern of medication which was considered part of their usual care. Medication was maintained stable 3 months prior the study and throughout the study. M79.7 Fibromyalgia Behavior Behavior Behavior Intervention group: In the Amygdala and Insula recovery intervention, the hypothesis is that changing emotion and cognition is more effective when the body moves. This psychotherapy approach focuses on improving coping skills and strategies for stressful situations by supposedly interrupting conditioned anxiety or fear responses from the Amygdala. This intervention consists of behavioral and psychological techniques such as cognitive therapy, breathing, meditation and neuro-linguistic programming. The amygdala and insula recovery technique will be practiced in 8 weeks based on the table below. Intervention group: The group will receive aerobic exercise in two months. The exercises will include two parts: static aerobic exercise and dynamic aerobic exercise. In general, the exercises will consist of 4 main parts. 1) warm up; It will include stretching movements, hypothetical line movements, cross-arm movements, arm rotations, neck rotations, cross-leg movements, sit-ups, 2) static aerobic exercise; Includes climbers walking, Palank, Palank with knee touch, and ski movement. 3) Dynamic aerobic exercise; It will include jogging at 70% of your maximum heart rate. 4) cooling down; It will include stretching, cross-linking, sitting, lying down and cradle movement. Exercises are performed with behavioral techniques and with the guidance of sports instructors and in a modified manner in accordance with the physical fitness of patients. The intervention will done in 8 weeks and 2 sessions per week. Patients engage in aerobic exercise for 30 to 45 minutes per session Control group: Participants in the control condition meet at least once a week at the research center and can talk about their illness and daily life. If they wish, they may also talk to nurses and doctors. Symptoms of Depression. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Beck Questionnaire. Symptoms of Anxiety. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Beck Questionnaire. Perceived Stress. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Cohen Questionnaire. Emotion Regulation. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Emotion Regulation Problems Questionnaire. Sleep Quality. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Pittsburgh Questionnaire. Sleep Pattern. Timepoint: Before intervention- 8 weeks later- 4 weeks later. Method of measurement: Insomnia Severity Scale and Sleep tables. Kermanshah University of Medical Sciences Approved 2023-01-30 Kermanshah University of Medical Sciences Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)