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IRCT20210104049937N1 IRCT 2021-04-21 Esfahan University of Medical Sciences The effect of mindfulness on diabetes The effectiveness of online Mindfulness-Based Stress Reduction (MBSR) intervention on physical, psychological and cognitive health indicators in adolescents with type 1diabetes in Isfahan 2021-04-19 anticipated 50 Complete https://irct.ir/trial/53533 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the restricted randomization method of the type of "random allocation law" will be implemented by a person separate from other researchers. In this way, in the first stage, the required number of specified samples (50 people) will be selected from the people who meet the inclusion criteria. And in the second step, we assign a number from 1 to 50 to each of these people, respectively. In the third step, we produce 50 random numbers without repetition between 1 and 50 by Excel software and this is the random sequence we want. Each of these numbers corresponds to the number assigned to each of the people we have specified in the initial list of 50 selected. In this study, we consider even numbers for the intervention group and odd numbers for the control group, and of course this is not obvious to the participant before performing random allocation. N/A Type one diabetes. Intervention 1: Intervention group: Intervention group: Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The regular agenda of each session will include reviewing the homework of the previous session, feedback, troubleshooting questions, teaching content and techniques, meditation skills, discussing stress, coping method and homework. The material presented during the 8 sessions includes the following: Introduction of mindfulness training, training and exercises related to the state of mindfulness exercises, attention to breathing, body scanning exercises, doing sitting care, doing yoga movements, doing mind eating exercises Consciously, taking care of conscious mind walking, preparing a personal mindfulness program. Participants are asked to do mindfulness exercises for 45 minutes on a daily basis as homework. Intervention 2: Control group: The control group is under routine care and no intervention is performed on them. Yes - There is a plan to make this available What will be shared: Part of the patients' demographic information and the main outcome can be shared. When: One year after printing the results To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Scientific uses Where to obtain: Zahra Nouri Sari z.noooori1994@gmail.com How to obtain: The data is sent by official request and by email Comments:
public Zahra Nouri Sari
No. 15, Moin Alley, Farrokhi St.
Najaf Abad Iran (Islamic Republic of) 8514758994 +98 31 4264 4635 z.noooori1994@gmail.com Esfahan University of Medical Sciences scientific Dr. Maryam Esmaili
Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 31 3793 5500 mar_yam_es@yahoo.com University of Esfahan Iran (Islamic Republic of) Adolescents with type 1 diabetes who have had diabetes for more than a year. Adolescents with type 1 diabetes who have a hemoglobin A1C above 7%. Adolescents with type 1 diabetes who have the ability to work with e-learning software and access the Internet. Adolescents with type 1 diabetes who live in Isfahan province. 15 years 25 years Both People with severe psychiatric illnesses. People with other autoimmune diseases in addition to diabetes. Those who use psychotropic drugs or substance abuse. Those with physical and mental disabilities. Those who are pregnant. E10 Type 1 diabetes mellitus Behavior Behavior Intervention group: Intervention group: Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The regular agenda of each session will include reviewing the homework of the previous session, feedback, troubleshooting questions, teaching content and techniques, meditation skills, discussing stress, coping method and homework. The material presented during the 8 sessions includes the following: Introduction of mindfulness training, training and exercises related to the state of mindfulness exercises, attention to breathing, body scanning exercises, doing sitting care, doing yoga movements, doing mind eating exercises Consciously, taking care of conscious mind walking, preparing a personal mindfulness program. Participants are asked to do mindfulness exercises for 45 minutes on a daily basis as homework. Control group: The control group is under routine care and no intervention is performed on them. Diabetes distress. Timepoint: Before and after the intervention. Method of measurement: Problem Areas in Diabetes Questionnaire; Iranian version. Blood sugar control. Timepoint: Before and after the intervention. Method of measurement: Blood test for hemoglobinA1C. Psychological well-being. Timepoint: Before and after the intervention. Method of measurement: Ryff's Scales of Psychological Well-being; Short Form. Attentional bias. Timepoint: Before and after the intervention. Method of measurement: Modified Stroop Test (emotional). Esfahan University of Medical Sciences Approved 2020-11-18 Ethics Committee of Isfahan University Room 325, 3rd Floor, Central Building, University of Isfahan, Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)