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IRCT20190813044527N1 IRCT 2020-01-29 Esfahan University of Medical Sciences The Effect of Mindfulness Based Stress Management on Glycemic Control and Mental Health in Patients with Diabetes Mellitus Evaluation of the effects of mindfulness meditation on glycemic control and mental health in patients with diabetes type II , Imam Ali City Comprehensive Health Center , 2018 2018-07-23 anticipated 110 Complete https://irct.ir/trial/41518 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, 108 diabetic patients with inclusion criteria will be selected by convenient sampling from the Imam Ali Comprehensive Health care Center in Isfahan. All participants will be invited to an introduction session, and a code will be assigned to each patient in front of their name and contact number. These codes will be randomly divided into two groups of 54 people using random allocation software v. 2.0 developed by Mahmood Saghaei and downloaded for free from Google. Then, based on the resulting list and contact numbers provided during the introduction session, we will contact with the intervention group patients, and the necessary coordination will be done. N/A DIABETES. Intervention 1: Intervention group: Eight 2-hour sessions once a week are taught by an expert psychologist, followed by 4 weeks homework which will be weekly reported by the patient. The topics of these sessions include explanations of mindfulness, physical activity and yoga exercises, receiving feedback and answering the questions, breathing exercises, and sleep hygiene education. Intervention 2: Control group: This group is under routine care based on national guidelines for diabetes mellitus management. Yes - There is a plan to make this available What will be shared: Whole data will be available When: Immediately after publishing manuscript To whom: To whom is in need to this data Conditions: Email to Dr Anahita Babak, Email: babakanahita@yahoo.com Where to obtain: Dr Anahita Babak Email: babakanahita@yahoo.com How to obtain: Send an Email to Dr Anahita Babak Comments:
public Dr Anahita Babak
Isfahan University of Medical Sciences , Hezar Jerib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8112 babakanahita@yahoo.com Esfahan University of Medical Sciences scientific Dr Anahita Babak
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 8112 babakanahita@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Diabetes Mellitus with the approval of a physician having a health record in the health center Age between 30-59 years HbA1c ranged between 7-9% History of diabetes for at least 6 months informed consent 30 years 59 years Female acute psychological disorders Chronic diseases such as cancer or any other serious medical condition pregnancy and lactation alcohol and substance abuse end organ damage caused by diabetes psychological treatment in the past year E08 Diabetes mellitus due to underlying condition Other Other Intervention group: Eight 2-hour sessions once a week are taught by an expert psychologist, followed by 4 weeks homework which will be weekly reported by the patient. The topics of these sessions include explanations of mindfulness, physical activity and yoga exercises, receiving feedback and answering the questions, breathing exercises, and sleep hygiene education. Control group: This group is under routine care based on national guidelines for diabetes mellitus management Anxiety, Depression and Stress. Timepoint: Beginning of the study and 13 weeks after the intervention. Method of measurement: DASS21 questionnaire. Fasting Blood Sugar. Timepoint: Beginning of the study and 13 weeks after the intervention. Method of measurement: fasting venous blood sample. HbA1c. Timepoint: Beginning of the study and 13 weeks after the intervention. Method of measurement: fasting venous blood sample. Sleep quality. Timepoint: before and 13 weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality questionnaire. Esfahan University of Medical Sciences Approved 2018-12-12 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)