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IRCT20120215009014N440 IRCT 2022-09-09 Hamedan University of Medical Sciences Effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes Effect of mindfulness-based group counseling versus control group on perceived stress in pregnant women with gestational diabetes: a double-blind randomized clinical trial 2022-10-23 anticipated 80 Complete https://irct.ir/trial/65780 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached. N/A Gestational diabetes mellitus. Intervention 1: Intervention group: Routine care for diabetic patients, in addition to group counseling based on mindfulness, including 8 sessions of 60 to 90 minutes once a week (including the concept of mindfulness, automatic guidance system, facing obstacles, breathing meditation practice, sitting meditation practice, breathing space practice, body inspection awareness of breathing and body and sounds and thoughts, anxiety and its relationship with stress, awareness of pleasant and unpleasant events, self-care, conscious yoga, sleep hygiene, and preparing a list of enjoyable activities). Intervention 2: Control group: Just routine care for diabetic patients. 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 It depends on the situation and the results of the study as well as the approval of the financial supporting organization.
public Niloofar Anajafi Marzijani
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 niloofaranajafi@yahoo.com Hamedan University of Medical Sciences scientific Dr. Zahra Masoomi
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 zahramid2001@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age 16 to 45 years Gestational age of 28 weeks and more Gestational Diabetes Having stress 16 years 45 years Female History of mental illness Occurrence of fetal complications O24.4 Gestational diabetes mellitus Other Other Intervention group: Routine care for diabetic patients, in addition to group counseling based on mindfulness, including 8 sessions of 60 to 90 minutes once a week (including the concept of mindfulness, automatic guidance system, facing obstacles, breathing meditation practice, sitting meditation practice, breathing space practice, body inspection awareness of breathing and body and sounds and thoughts, anxiety and its relationship with stress, awareness of pleasant and unpleasant events, self-care, conscious yoga, sleep hygiene, and preparing a list of enjoyable activities) Control group: Just routine care for diabetic patients Perceived stress score. Timepoint: Before the intervention and 8 weeks later. Method of measurement: Using Cohen's Perceived Stress Questionnaire. Hamedan University of Medical Sciences Approved 2022-08-20 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)