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IRCT20220813055677N1 IRCT 2022-09-08 Bojnourd University of Medical Sciences The method of progressive muscle relaxation on the level of anxiety and vital signs of the elderly Investigating the effect of progressive muscle relaxation on the level of anxiety and vital signs of hospitalized elderly 2022-08-23 anticipated 76 Complete https://irct.ir/trial/65274 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: In this study, the Block Randomization method with blocks of 4 to 6 will be used. We will use Excel software and function (rand) to prepare random sequences. A specific numerical code will be assigned to each of the randomly generated sequences. When each individual enters the study, the group to which the individual belongs will be announced by contacting the epidemiologist of the study. The names and surnames of the patients along with the code created for them and the type of intervention received are registered and kept by the epidemiologist of the study who has the random chain, Blinding description: This study is one-sided blind in that the research assistant who is responsible for completing the questionnaires and measuring vital signs is unaware of the group to which the patient belongs. This research is a one-way blinded randomized clinical trial study on the elderly hospitalized in Rasoul Akram Hospital, in such a way that after receiving the code of ethics and registration on the IRCT website and receiving the registration code at the clinical trial center, we will start recruiting patients. did Individuals after obtaining written informed consent from the patients which is in Appendix 5 (it should be noted that patients must sign two consent forms, one of which must be given to the researcher and the other to the patients) and after meeting the entry and non-entry criteria. , will enter the study and after receiving the initial information by the researcher's assistant, the people will be randomly and completely hidden and blinded as described above, placed in one or two intervention and control groups. The information of these people will be collected in CRF (Clinical Report Forms) which is in Appendix 6. The participants were divided into two intervention and control groups, the control group at 10-11 in the morning and 17-18 in the evening on two occasions for 3 consecutive days with an interval of 20 minutes, the vital signs (blood pressure, heart rate, respiration) are controlled and recorded in 24 4 shifts (three days in total 12 times) will be controlled and recorded by the researcher's assistant and at first the study vans will complete the existing questionnaire. It should be noted that the questionnaires are completed by the participants themselves in the study with them, but if they are unable to complete them with the help of the researcher, it will be completed in the form of an interview. N/A Investigating the effect of progressive muscle relaxation on the level of anxiety and vital signs of hospitalized elderly. Intervention 1: Intervention group: The control group will be monitored and recorded vital signs (blood pressure, heart rate, breathing) at 10-11 am and 17-18 pm on two occasions for 3 consecutive days at 20 minutes intervals. In 24 hours, 4 times (three days in total 12 times) are controlled and recorded by the assistant of the researcher and he completed the existing questionnaire at the beginning and end of the study. It should be noted that the questionnaires are completed by the study participants themselves or with them, but if they are unable to complete it with the help of the researcher, it is completed in the form of an interview. Blood, caffeinated drinks, feeling of elimination, consumption of heavy meals) and with a digital sphygmomanometer in a semi-sitting position, blood pressure of the patients from the right hand, heart rate by a pulse oximeter device (Beaver model) by the help of the researcher who has been trained by the researcher. And the correctness of the work of the researcher's assistant and the devices used and the method of measurement by him have been ensured and controlled and tested, and no intervention was done in these people. In the intervention group, the technique was performed on the patient's bed for 3 consecutive days in such a way that step by step along with the researcher, he was first taught step by step relaxation by progressive muscle relaxation method and he was asked to relax each of his muscles. Contract for 5 seconds. then release it for 10 seconds, in this way, first for the right hand and right forearm, right arm, left hand and forearm, left arm, forehead, eyes and cheeks, mouth and chin, neck, shoulders, shoulder girdle and the back of the neck, chest and abdomen, hips, right leg thigh, right leg leg, left thigh leg, left leg leg, then be completely relaxed and do deep tennis for 2 minutes in relaxation and relaxation and repeat this process twice a day. And from the second day of hospitalization (according to the approval of the attending physician), they were allowed to do relaxation exercises. Before performing the technique, all the additional equipment of the patient, such as watches, bracelets, rings, and fittings, and all equipment that could be separated, were separated from the patient and placed next to the patient. The patient is in a semi-sitting position with an angle of 30 degrees, according to the conditions of the inpatient department, this case is available for all subjects of the study. This technique is performed for the patient at 10-11 in the morning and 17-18 in the evening for 3 consecutive days for 20 minutes each time. After performing the technique, the vital signs (blood pressure, heart rate, breathing) are controlled and recorded by the assistant of the researcher after 20 minutes. In 24 hours, 4 times (three days in total 12 times) before and after the implementation of the technique, the patients' vital signs are monitored and recorded. Intervention 2: Control group: Individual characteristics questionnaire at the beginning of the study, anxiety questionnaire at the beginning of the study vans will be completed. Vital signs will be measured every day between 10-11 in the morning and 17-18 in the evening on two occasions with an interval of 20 minutes for 3 consecutive days by the researcher's assistant and recorded in the relevant checklist. Yes - There is a plan to make this available What will be shared: In this study, all clinical and demographic information is coded in SPSS software for sharing. When: The access period starts 6 months after the publication of the results To whom: Doctors and nurses working in academic institutions related to medical sciences Conditions: Use of this research data will be permitted in meta-analysis studies Where to obtain: Contact: alisoheily70@gmail.com to receive the data How to obtain: The applicant will be contacted within 48 hours, and if the academic and employment records of the research environment are properly submitted, research data will be provided to the applicant upon confirmation of the identity of the originator. Comments:
public Fateme Khorashadizadeh
Faculty of Nursing building, south side of Imam Ali Hospital, Shahriar St.
Bojnurd Iran (Islamic Republic of) 94176-96786 009858332297096 khorashadizadehf891@gmail.com Bojnourd University of Medical Sciences scientific Fateme Khorashadizadeh
Faculty of Nursing building, south side of Imam Ali Hospital, Shahriar St.
Bojnurd Iran (Islamic Republic of) 94176-96786 009858332297296 khorashadizadehf891@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Age 60 years and above Having at least mild anxiety upon entering the study Consent of the individual to participate in the study Absence of unstable chronic diseases Absence of neurological defects such as (stroke, Parkinson's disease and paralysis) Not taking anti-anxiety drugs Absence of limiting musculoskeletal disorders Absence of severe congenital defects (vision, hearing and mental disorders, etc.) People who have not participated in similar research. Doctor's approval to participate in the study and no other medical restrictions Absence of previously known mental disorder 60 years no limit Both Unstable chronic diseases Neurological defects such as (stroke, Parkinson's disease and paralysis) Taking anti-anxiety drugs Existence of restrictive musculoskeletal disorders Existence of severe congenital defects (vision, hearing and mental disorders, etc.) Participation in similar research Users of anti-anxiety drugs before hospitalization Hospitalization due to complementary treatments and surgery Disinterested in participating in the study Rehabilitation N/A Intervention group: The control group will be monitored and recorded vital signs (blood pressure, heart rate, breathing) at 10-11 am and 17-18 pm on two occasions for 3 consecutive days at 20 minutes intervals. In 24 hours, 4 times (three days in total 12 times) are controlled and recorded by the assistant of the researcher and he completed the existing questionnaire at the beginning and end of the study. It should be noted that the questionnaires are completed by the study participants themselves or with them, but if they are unable to complete it with the help of the researcher, it is completed in the form of an interview. Blood, caffeinated drinks, feeling of elimination, consumption of heavy meals) and with a digital sphygmomanometer in a semi-sitting position, blood pressure of the patients from the right hand, heart rate by a pulse oximeter device (Beaver model) by the help of the researcher who has been trained by the researcher. And the correctness of the work of the researcher's assistant and the devices used and the method of measurement by him have been ensured and controlled and tested, and no intervention was done in these people. In the intervention group, the technique was performed on the patient's bed for 3 consecutive days in such a way that step by step along with the researcher, he was first taught step by step relaxation by progressive muscle relaxation method and he was asked to relax each of his muscles. Contract for 5 seconds. then release it for 10 seconds, in this way, first for the right hand and right forearm, right arm, left hand and forearm, left arm, forehead, eyes and cheeks, mouth and chin, neck, shoulders, shoulder girdle and the back of the neck, chest and abdomen, hips, right leg thigh, right leg leg, left thigh leg, left leg leg, then be completely relaxed and do deep tennis for 2 minutes in relaxation and relaxation and repeat this process twice a day. And from the second day of hospitalization (according to the approval of the attending physician), they were allowed to do relaxation exercises. Before performing the technique, all the additional equipment of the patient, such as watches, bracelets, rings, and fittings, and all equipment that could be separated, were separated from the patient and placed next to the patient. The patient is in a semi-sitting position with an angle of 30 degrees, according to the conditions of the inpatient department, this case is available for all subjects of the study. This technique is performed for the patient at 10-11 in the morning and 17-18 in the evening for 3 consecutive days for 20 minutes each time. After performing the technique, the vital signs (blood pressure, heart rate, breathing) are controlled and recorded by the assistant of the researcher after 20 minutes. In 24 hours, 4 times (three days in total 12 times) before and after the implementation of the technique, the patients' vital signs are monitored and recorded. Control group: Individual characteristics questionnaire at the beginning of the study, anxiety questionnaire at the beginning of the study vans will be completed. Vital signs will be measured every day between 10-11 in the morning and 17-18 in the evening on two occasions with an interval of 20 minutes for 3 consecutive days by the researcher's assistant and recorded in the relevant checklist. Anxiety score. Timepoint: At the beginning and end of the study. Method of measurement: Beck's anxiety questionnaire. Blood pressure. Timepoint: Four times a day for three days before and 20 minutes after the intervention. Method of measurement: KD 595 digital easy life blood pressure monitor. Breathing rate. Timepoint: Four times a day for three days before and 20 minutes after the intervention. Method of measurement: It is counted by the research assistant in one minute. Number of heartbeats. Timepoint: Four times a day for three days before and 20 minutes after the intervention. Method of measurement: Measurement with pulse oximeter. Bojnourd University of Medical Sciences Approved 2022-07-06 Ethics Committee of North Khorasan University of Medical Sciences Faculty of Nursing building, south side of Imam Ali Hospital, Shahriar St Bojnurd North Khorasan Iran (Islamic Republic of)