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IRCT20190119042409N1 IRCT 2019-04-19 Shahid Beheshti University of Medical Sciences The Effectiveness of relaxation exercises in elderly people with type 2 diabetes The Effectiveness of relaxation exercises on decreasing depression, anxiety and stress in elderly people with type 2 diabetes 2019-02-04 anticipated 84 Complete https://irct.ir/trial/36947 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sampling method is block Randomization, using four blocks. The elderly people From four urban centers which are covered by Health Center number one in Isfahan, with diabetes type 2 who are eligible to enter the study, are randomly divided into two groups of control and intervention. Next the first elderly person who is eligible to enter the study is determined into control or intervention group by the division according to the following table. The sampling is started from right to left respectively. First in block 3 with the admission of the first elderly person who is eligible to enter the study and according to block 3 tabale, the people are placed according following order: the first in the control group, the second in the intervention group, The third in the control group and the fourth in the intervention group. The next block for sampling is number one. The first person placed in the intervention group, the second in the intervention group too, the third and fourth in the control group. As the same way the sampling is done according to the table and specified block from right to left and based on the division of the control and intervention group to reach the sample size to 84 people. Arrangement of the blocks are right to left 3 3 3 1 3 2 1 4 3 2 4 3 3 2 1 4 2 4 4 1 2 4 4 3 2 block1 block2 block3 block4 (Blocks table A: Treatment B: Control ) A A B B A B A B B A B A B B A A. N/A Type 2 diabetes. Intervention 1: Intervention group: Relaxation exercises are taught to the elderly people in 3 sessions by the researcher and then these exercises are practiced twice a day by the elderly people at home for six weeks. Intervention 2: Control group: Relaxation exercises are not done in this group and DASS-21 questionnaire is completed once in the baseline and then 6 weeks after the baseline. 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 No more information
public Bahareh khajeheyan
Faiz Valley
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3438 0025 bkhajeheyan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Bahareh khajeheyan
Faiz Valley
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3438 0025 bkhajeheyan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Being volunteer to participate in the study Age 60 years old and over Type 2 diabetes for at least six months Acceptable listening and speaking ability to learn relaxation techniques The ability to read educational materials or the presence of a family member who agrees to read it for the elderly Mild to moderate stress, anxiety and depression based on the DASS-21 questionnaire scale 60 years no limit Both Severe diabetes complications Not having alcohol and drug addiction No use of antidepressants and no known mental illness, including severe depression Not having a history of receiving relaxation training E11 Type 2 diabetes mellitus Lifestyle Lifestyle Intervention group: Relaxation exercises are taught to the elderly people in 3 sessions by the researcher and then these exercises are practiced twice a day by the elderly people at home for six weeks. Control group: Relaxation exercises are not done in this group and DASS-21 questionnaire is completed once in the baseline and then 6 weeks after the baseline. Depression Score. Timepoint: Measurement of depression at the beginning of the study and 6 weeks after the intervention. Method of measurement: DASS-21 questionnaire. Anxiety Score. Timepoint: Measurement of Anxiety at the beginning of the study and 6 weeks after the intervention. Method of measurement: DASS-21 questionnaire. Stress Score. Timepoint: Measurement of stress at the beginning of the study and 6 weeks after the intervention. Method of measurement: DASS-21 questionnaire. Shahid Beheshti University of Medical Sciences Approved 2019-01-15 Ethics Committee of Shahid Beheshti University of Medical Sciences Thirteenth floor block A- Headquarters of the Ministry of Health and Medical Education- Between South Falamak and Zarafshan- Ghods Town (West)- Tehran Tehran Tehran Iran (Islamic Republic of)