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IRCT20211110053030N1 IRCT 2021-12-27 Ilam University of Medical Sciences Kegel exercise effect on incontinence, Frailty index, and Self-esteem in elderly men after Prostatectomy Effects of Kegel exercise effect on urinary incontinence, frailty index and self-esteem in elderly men after Transurethral Resection of Prostate (TURP) in Ilam county in 2021 (a randomized, single-blinded, controlled clinical trial) 2021-12-11 anticipated 76 Complete https://irct.ir/trial/59950 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After entering the research based on the inclusion criteria, Balance-block randomization with 4 permutations will be used to assign individuals to control and intervention groups as random allocation 1.CCII, 2. CICI, 3. CIIC, 4. IICC, 5. ICIC and 6. ICCI were in which the letter C (control) and the letter I (intervention). RAS (Research Analysis and Statistics) software will be used to generate random blocks, and a random number table will be used to select each block. Envelopes will be embedded to hide the created sequence, which will be exactly the same. They are written random codes and each code will represent a type of a block that will contain 4 letters (P or G). The list of codes prepared for each envelope will be determined by the research team and the final list will be at the discretion of the lead researcher. This method will ensure that the doctor or nurse prescribing the training does not know the type of intervention, Blinding description: We blind interviewers the have rule for data gathering form participants as he/she just access of codes prepared for each envelope (randomization step) and no other information may lead to leak of random sequences. N/A Condition 1: Urinary Incontinence. Condition 2: Frailty Index. Condition 3: Self esteem. Intervention 1: Intervention group: Kegel exercise includes a series of contractions that target the pelvic floor muscles (bladder muscles, valvular muscles, pelvic muscles). After being eligible for the study, the people in the intervention group will be asked how to do the Kegel exercise. First, to identify the location of the pelvic floor muscles, we explain to the person that when you are urinating, try to cut off and connect your urine flow. It is the pelvic floor muscles that cut and connect the flow of your urine. Do this for two or three times to find out the exact location and work of these muscles. Then, after the patient identifies his pelvic floor muscles, we ask him to contract these muscles for five seconds (count from one thousand and one to one thousand and five) and relax these muscles after counting. This move is a Kegel sport. The intervention group will perform sixty of these contractions daily three times a day (20 in the morning, 20 at noon, and 20 at bedtime) for 12 weeks. In the eighth week of the intervention group, the questionnaires on fragility, self-esteem, and urinary incontinence will be completed again. Then, one month after the end of the Kegel exercise, in the twelfth week of the presence of individuals in the intervention group, the three mentioned questionnaires will be completed again and the data will be entered into SPSS V.21 software for analysis. The intervention group will receive a pamphlet introducing the pelvic floor muscles and how the Kegel exercise was performed by the research team using credible sources, as well as a checklist in which the Kegel exercise is expected to be counted and counted. Placed, will receive. In addition, the members of the intervention group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also be in contact with the members of the intervention group on a weekly basis to check the manner and number of Kegel exercises performed to check the eligibility of individuals to participate in the continuation of the study.In addition, the informed consent form will be obtained from individuals at the beginning of the research. Intervention 2: Control group: The subjects in the control group did not do any kegel exercises after entering the study, and the subjects in this group after the eighth week and one month after the twelfth week of the study, fragility questionnaires, self-esteem, and urinary incontinence were complete the option and the data will be entered into SPSS V.21 software for analysis. Of course, in order not to be deprived of the benefits of research, the pamphlet will receive how to do Kegel exercise, with the difference that in this pamphlet, the number of Kegel exercises to do, the reason for doing Kegel exercise is not written. In addition, people in the control group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also check the absence of Kegel exercise and the control group's awareness of the existence of such exercise by being in contact with the control group on a weekly basis to check the eligibility of individuals to participate in the continuation of the research.In addition, the informed consent form will be obtained from individuals at the beginning of the research. Yes - There is a plan to make this available What will be shared: All potential data can be shared after identifying individuals. When: Access period starts 6 months after the results are published To whom: Doctors, nurses, surgeons, and staff of health centers Conditions: Prerequisites for submitting an application include use for referral for reference, faculty or student being a researcher or working in a hospital or surgical clinic. Where to obtain: The responsible author can be contacted at the email address: mozafaric@yahoo.com and the student's email address: rezawest10@gmail.com How to obtain: After completing the study and publishing the results, by sending an email to the responsible author, he can access the documents for a maximum of 6 weeks. Comments:
public Mosayeb Mozafari
Bangangab, Ilam University of Medical Sciences, Educational Management
ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 rezawest10@gmail.com Ilam University of Medical Sciences scientific Mosayeb Mozafari
Bangangab, Ilam University of Medical Sciences, Educational Management
Ilam Iran (Islamic Republic of) 6939177143 +98 84 3222 7134 rezawest10@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Transurethral Resection of Prostate (TURP) in at least one day and at most 3 days Age 65 years and older Lack of other history of pelvic surgery Failure to diagnose prostate cancer after surgery based on biopsy and pathology Willingness to participate in research and to have Informed Consent Primary and higher literacy rates Achieving a score of 24 and above in the Mini-Mental State Examination (MMSE) to determine whether he is teachable and has no dementia Score 4 or higher on the Urinary Incontinence Diagnosis Questionnaire (QUID) Score higher than 5 on the Edmonton Frailty Scale (EFS) 65 years no limit Male Having a urinary tract infection immediately after surgery Having a heart attack and stroke after entering the intervention N39.4 Other specified urinary incontinence Treatment - Other Treatment - Other Intervention group: Kegel exercise includes a series of contractions that target the pelvic floor muscles (bladder muscles, valvular muscles, pelvic muscles). After being eligible for the study, the people in the intervention group will be asked how to do the Kegel exercise. First, to identify the location of the pelvic floor muscles, we explain to the person that when you are urinating, try to cut off and connect your urine flow. It is the pelvic floor muscles that cut and connect the flow of your urine. Do this for two or three times to find out the exact location and work of these muscles. Then, after the patient identifies his pelvic floor muscles, we ask him to contract these muscles for five seconds (count from one thousand and one to one thousand and five) and relax these muscles after counting. This move is a Kegel sport. The intervention group will perform sixty of these contractions daily three times a day (20 in the morning, 20 at noon, and 20 at bedtime) for 12 weeks. In the eighth week of the intervention group, the questionnaires on fragility, self-esteem, and urinary incontinence will be completed again. Then, one month after the end of the Kegel exercise, in the twelfth week of the presence of individuals in the intervention group, the three mentioned questionnaires will be completed again and the data will be entered into SPSS V.21 software for analysis. The intervention group will receive a pamphlet introducing the pelvic floor muscles and how the Kegel exercise was performed by the research team using credible sources, as well as a checklist in which the Kegel exercise is expected to be counted and counted. Placed, will receive. In addition, the members of the intervention group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also be in contact with the members of the intervention group on a weekly basis to check the manner and number of Kegel exercises performed to check the eligibility of individuals to participate in the continuation of the study.In addition, the informed consent form will be obtained from individuals at the beginning of the research. Control group: The subjects in the control group did not do any kegel exercises after entering the study, and the subjects in this group after the eighth week and one month after the twelfth week of the study, fragility questionnaires, self-esteem, and urinary incontinence were complete the option and the data will be entered into SPSS V.21 software for analysis. Of course, in order not to be deprived of the benefits of research, the pamphlet will receive how to do Kegel exercise, with the difference that in this pamphlet, the number of Kegel exercises to do, the reason for doing Kegel exercise is not written. In addition, people in the control group will have the contact number of the researcher to contact him in case of questions or need guidance. The researcher will also check the absence of Kegel exercise and the control group's awareness of the existence of such exercise by being in contact with the control group on a weekly basis to check the eligibility of individuals to participate in the continuation of the research.In addition, the informed consent form will be obtained from individuals at the beginning of the research. Urinary incontinence. Timepoint: Before enrollment, 8 weeks after enrollment, one month after enrollment. Method of measurement: Abridged Form of the International Urinary Incontinence Counseling Questionnaire (ICIQ). Frailty Index. Timepoint: Before enrollment, 8 weeks after enrollment, one month after enrollment. Method of measurement: Edmonton Frailty scale(EFS). Self-esteem. Timepoint: Before enrollment, 8 weeks after enrollment, one month after enrollment. Method of measurement: Rosenberg Self-Esteem Scale (RSES). No - possible costs are paid by the student himself. Approved 2021-12-06 Ethics Committee of Ilam University of Medical Sciences Bangangab, Ilam University of Medical Sciences, Research and Technology Building Ilam Ilam Iran (Islamic Republic of)