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IRCT20230304057605N1 IRCT 2023-04-11 Shahed University The effect of Benson relaxation technique on sleep quality, anxiety, stress and depression in the elderly with knee osteoarthritis The effect of Benson relaxation technique on sleep quality, anxiety, stress and depression in the elderly with knee osteoarthritis 2023-04-19 anticipated 86 Complete https://irct.ir/trial/68964 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are included in the study by block randomization and parallel allocation. First, by assigning the letter A to the test group and the letter B to the control group, the six states ABBA, BABA, ABAB, BBAA, AABB, BAAB are written on separate sheets and thrown into a container. By chance, one of these sheets is taken out of the container and the combination written on it is remembered, and that sheet is thrown into the container again. Because the sample size in this study is 86 patients, this procedure is repeated 22 times and each time the composition written on each sheet is noted in the sequence of the composition written on the previous sheet. Then, a number from 1 to 86 is assigned to each of the letters in the order of the letters noted in a row. Each letter is placed in an envelope and the number of that letter is written on the envelope. Every time a disease is selected, one of these envelopes is opened according to the number written on the envelope and the patient is placed in the test or control group, Blinding description: Participants. N/A Osteoarthritis. Intervention 1: Intervention group: The patient is asked to sit, close his eyes, gradually relax his body muscles from the tip of the toes to the face, inhale through the nose and slowly exhale through the mouth. Be aware of your breathing and repeat in your mind the word that always reminds you of peace in every exhalation. The patient continues these exercises for 20 minutes. After this period, they keep their eyes closed for a few minutes and then open their eyes. This exercise is done twice a day for 1 month. Intervention 2: Control group: No intervention is performed in the control group. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Documents published in articles Where to obtain: mheidari@shahed.ac.ir How to obtain: Apply via academic email Comments:
public Mohammad Reza Keyhani Dehnavi
Shahed University, in front of the holy shrine of Imam Khomeini (RA), at the beginning of Tehran-Qom highway
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 3560 info@shahed.ac.ir Shahed University scientific Mohammad Reza Heidari
Shahed University, facing the Holy Shrine Imam Khomeini, Persian Gulf highway (Tehran-Qom),
Tehran Iran (Islamic Republic of) 18735/136 +98 21 5121 2146 mheidari@shahed.ac.ir Shahed University Iran (Islamic Republic of) Age over 60 years old Ability to complete the questionnaire Obtaining a total score of more than 5 (meaning low sleep quality) by PSQI 60 years no limit Both Dementia M19.90 Unspecified osteoarthritis, unspecified site Treatment - Other N/A Intervention group: The patient is asked to sit, close his eyes, gradually relax his body muscles from the tip of the toes to the face, inhale through the nose and slowly exhale through the mouth. Be aware of your breathing and repeat in your mind the word that always reminds you of peace in every exhalation. The patient continues these exercises for 20 minutes. After this period, they keep their eyes closed for a few minutes and then open their eyes. This exercise is done twice a day for 1 month. Control group: No intervention is performed in the control group. Sleep quality score in Pittsburgh Sleep Quality Index. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Depression score in Depression, Anxiety and Stress Scale. Timepoint: Before and after the intervention. Method of measurement: Depression, Anxiety and Stress Scale. Anxiety score in Depression, Anxiety and Stress Scale. Timepoint: Before and after the intervention. Method of measurement: Depression, Anxiety and Stress Scale. Stress score in Depression, Anxiety and Stress Scale. Timepoint: Before and after the intervention. Method of measurement: Depression, Anxiety and Stress Scale. Shahed University Approved 2023-01-02 Ethics Committee of Shahed University Shahed University, At the beginning of Tehran- Qhom Road Tehran Tehran Iran (Islamic Republic of)