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IRCT20250605066079N1 IRCT 2025-07-04 Khomein Faculty of Medical Sciencesا Investigating the effect of progressive muscle relaxation technique on fatigue, depression, and quality of life in patients with hypothyroidism Investigating the effect of progressive muscle relaxation technique on fatigue, depression, and quality of life in patients with hypothyroidism 2025-07-16 anticipated 64 Complete https://irct.ir/trial/84129 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: In this study, the control group receives only routine treatments, Randomization description: Patients are randomly assigned to two groups: intervention and control, using simple random numbers generated by software, Blinding description: In fact, this study is double-blind, so that the physician, members of both the intervention and control groups, the researcher who is responsible for administering the questionnaires at the end, and the analyst are blinded to the members of the groups. N/A Hypothyroid. Intervention 1: Intervention group:Patients in the intervention group will be taught the PMRT technique by the researcher in a separate room for 40 minutes. Then, they will be asked to perform this technique twice a day (morning and evening) for 20 minutes each time for 4 weeks based on the educational video sent to them. Patients will be instructed to take levothyroxine tablets in the morning on an empty stomach and not to eat anything for one hour after taking it that may interfere with the absorption of the drug and aggravate the symptoms of hypothyroidism. Patients will be instructed to avoid taking dietary supplements containing iodine and selenium, which affect the activity of the thyroid gland, during the intervention period without consulting a doctor and informing the researchers. Patients will be asked to avoid changing their diet or taking herbal medicines without consulting a doctor and informing the researchers during the intervention period, and they will be instructed to keep their diet constant during this period. In addition, these patients are monitored by telephone every week to ensure that the instructions and training given are carried out correctly. At the end of 4 weeks, the questionnaires are completed by making a telephone call to the members of the intervention group by researcher number 2, who is outside the study group and blinded to the members of both groups, and the information obtained is compared. Intervention 2: Control group: Patients in this group are not given any information about PMRT and receive their routine treatments during the study period. They are only asked to complete the demographic information questionnaire, the Pepper Fatigue Questionnaire, and the ThyPRO-39 Quality of Life Questionnaire at the beginning and end of this period. These patients are monitored every week via telephone call and information about their health status is obtained. 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 There is no further information.
public Sara Mohammadi Farsani
Quds Street
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 sara.mohammadi.fars@gmail.com Khomein Faculty of Medical Sciences scientific Mehdi Safarabadi
Quds Street
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences Iran (Islamic Republic of) No communication problems Not having a physical problem that prevents you from exercising. Complete fluency in Persian No medical record indicating neurological or mental problems and no use of medications related to this problem Voluntary consent to participate in the study Over 18 years old Not being pregnant for women Confirmation of clinical hypothyroidism by a specialist physician Absence of cognitive problems or impairment No previous experience using this technique Having a personal cell phone or having someone in the house who has a cell phone No drug addiction 18 years no limit Both Unwillingness to continue participating in the study for any reason The occurrence of any disabling physical disorder during the study that prevents movement Pregnancy during the study period ایجاد هر گونه مشکل در طول مطالعه برای بیمار The occurrence of a psychological crisis such as bereavement or divorce during the intervention period Patients with clinically confirmed hypothyroidism Rehabilitation N/A Intervention group:Patients in the intervention group will be taught the PMRT technique by the researcher in a separate room for 40 minutes. Then, they will be asked to perform this technique twice a day (morning and evening) for 20 minutes each time for 4 weeks based on the educational video sent to them. Patients will be instructed to take levothyroxine tablets in the morning on an empty stomach and not to eat anything for one hour after taking it that may interfere with the absorption of the drug and aggravate the symptoms of hypothyroidism. Patients will be instructed to avoid taking dietary supplements containing iodine and selenium, which affect the activity of the thyroid gland, during the intervention period without consulting a doctor and informing the researchers. Patients will be asked to avoid changing their diet or taking herbal medicines without consulting a doctor and informing the researchers during the intervention period, and they will be instructed to keep their diet constant during this period. In addition, these patients are monitored by telephone every week to ensure that the instructions and training given are carried out correctly. At the end of 4 weeks, the questionnaires are completed by making a telephone call to the members of the intervention group by researcher number 2, who is outside the study group and blinded to the members of both groups, and the information obtained is compared. Control group: Patients in this group are not given any information about PMRT and receive their routine treatments during the study period. They are only asked to complete the demographic information questionnaire, the Pepper Fatigue Questionnaire, and the ThyPRO-39 Quality of Life Questionnaire at the beginning and end of this period. These patients are monitored every week via telephone call and information about their health status is obtained. Fatigue. Timepoint: At the beginning of the study and at the end of the study (4 weeks). Method of measurement: Piper Fatigue Scale. Depression. Timepoint: At the beginning of the study and at the end of the study (4 weeks). Method of measurement: BDI-2 depression questionnaire. Quality of life. Timepoint: At the beginning of the study and at the end of the study (4 weeks). Method of measurement: Quality of Life Questionnaire for Patients with Hypothyroidism (ThyPRO39IR). Khomein Faculty of Medical Sciencesا Approved 2025-06-09 Ethics Committee of Khomein Faculty of Medical Sciences Khomein, Qods Blvd., Faculty of Medical Sciences Khomein Markazi Iran (Islamic Republic of)