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IRCT20181002041202N1 IRCT 2018-11-10 Mashhad University of Medical Sciences The Effect of couples supportive counseling on gestational diabetes The Effect of couples supportive counseling on self-care and blood sugar level in pregnant women with gestational diabetes 2018-11-06 anticipated 72 Complete https://irct.ir/trial/34201 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: - Randomized Method: Blocked Block. - Random unit: Individual. - Randomization Tool: Random Number Tables using www.randomization.com, Packet Envelopes, Statistical Software. - How to create a random sequence: For this method, firstly, the size of each specified block (for example, the quadruple block). Then write the blocks list and assign them numbers (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select random numbers between one to six (E.g., 1 4 5, etc.) and finally determine the allocation allocation based on random numbers (... AABB-BBAA-BABA-).. - Explanation about the concealment concealment method: The envelope method is that envelopes are prepared and printed by a member of the research team and random numbers with the help of the Randomaize.com site and inside the envelope. The door packs will be closed and its contents are not visible from the outside. Then, the purpose of the study is explained to the person who follows the conditions, and the person, if desired, signs the informed consent form and removes an envelope, then opens it and, based on the contents of the envelope, enters into the intervention or control group, Blinding description: The sample allocator to groups and data analyzers are blinded in this study. N/A Gestational Diabetes Mellitus. Intervention 1: Intervention group: In addition to the usual gestational diabetes education provided in Hospital, three sessions of supportive counseling with the husbands of research units in three consecutive weeks, each week for 60 minutes using the approach Based on the evacuation of emotions, support for coping strategies, problem solving and practical guidance. Intervention 2: Control group: Typical gestational diabetes education in diet, physical activity, blood glucose monitoring, Drug use by a gynecologist at the hospital's diabetes clinic or in individual and group sessions in the training sessions Will be received by the midwife. The number of sessions will vary depending on the needs of the people. 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 Is under review.
public Rostampour, Sahar
Mashad
Mashad Iran (Islamic Republic of) 000 +98 51 3278 2261 Rostamps951@mums.ac.ir Mashhad University of Medical Sciences scientific Rostampour, Sahar
Mashad
Mashad Iran (Islamic Republic of) 00000 +98 51 3278 2261 Rostamps951@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Type A2 gestational diabetes Husband's willingness to accompany the research Minimum fifth degree elementary education The gestational age is 26-30 weeks based on the first trimester ultrasound or precise LMP Iranian nationality Written informed consent Residence in Mashhad Phone Access Able to communicate verbally no limit no limit Female Tobacco and alcohol use Mental disorders before Pregnancy Obesity Cure for medical conditions highRisk pregnancy and taking corticoids Stressful events over the past 6 months Couples are among the staff working in the hospital O24.4 Diabetes mellitus arising in pregnancy Behavior Behavior Intervention group: In addition to the usual gestational diabetes education provided in Hospital, three sessions of supportive counseling with the husbands of research units in three consecutive weeks, each week for 60 minutes using the approach Based on the evacuation of emotions, support for coping strategies, problem solving and practical guidance. Control group: Typical gestational diabetes education in diet, physical activity, blood glucose monitoring, Drug use by a gynecologist at the hospital's diabetes clinic or in individual and group sessions in the training sessions Will be received by the midwife. The number of sessions will vary depending on the needs of the people Self-Care and Blood suger. Timepoint: Measure self-care scores and blood suger level at the beginning of the intervention and one month after the intervention. Method of measurement: Self-care diabetes questionnaire and fasting blood glucose and 2 hour plasma glucose test. Social support. Timepoint: At the beginning of the study and one month after the end of the intervention. Method of measurement: Social Support Questionnaire. Mashhad University of Medical Sciences Approved 2018-09-18 Ethics committee of Mashad University of Medical Sciences Mashad Mashad Razavi Khorasan Iran (Islamic Republic of)