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IRCT20201021049107N1 IRCT 2022-02-14 Zahedan University of Medical Sciences The effect of progressive muscle relaxation technique on fatigue, pain and quality of life of dialysis patients The effect of progressive muscle relaxation technique on fatigue, pain and quality of life patients undergoing dialysis 2021-03-10 anticipated 60 Complete https://irct.ir/trial/55013 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling will be done by available method. Then the selected patients are randomly divided into control and intervention groups. In this way, some envelopes containing the names of the groups are prepared and randomly arranged for the total number of participants. By referring each patient one of the envelops will be assigned to them subsequently. N/A Dialysis patients. Intervention 1: Intervention group: First, a questionnaire of demographic characteristics, fatigue, pain and quality of life for patients is completed by the researcher. Then, the technique of progressive muscle relaxation individually face to face in 2 to 3 sessions for one hour, on the day after dialysis, the time of which is determined in coordination with the patient and family, in the presence of a first-degree member of the patient (child, spouse) is taught at the patient's home by the researcher (If the patient is not able to perform the technique independently during the designated sessions, the training will continue until the learning is complete and the technique is performed independently). The first session will be technique training; the second session will be performing the technique by the patient in the presence of the researcher and the repetition of the technique training if necessary. The third session will be training with questions from the patient and answers to his questions during practice relaxation technique at home and performance and performing technique by the patient in the presence of the researcher. The audio file is provided to the intervention group through a compact disc with the researcher's own voice and an educational booklet containing images of the first and second steps of relaxation. The intervention group is asked to do relaxation exercises twice a day (morning and evening) for 12 weeks according to the schedule set at home. Each relaxation step takes about 20 minutes. The family member is also asked to supervise the patient performing the technique at home. Prior to the intervention, the researcher will undergo theoretical and practical training in relaxation techniques in several stages under the full supervision of a clinical psychologist. The technique is performed by first closing the patient's eyes, relaxing them as much as possible, and focusing all their attention on their breathing, taking five deep breaths, and each time filling the lungs with air and empty slowly. After this stage, patients perform muscle contraction and expansion for 14 groups of facial muscles (forehead, eyelids, jaws, and lips), neck muscles, fingers and palms, forearms, arms and shoulders, back and chest, abdomen, buttock, thighs, legs and soles of the feet. Each muscle contracts for 5 seconds and expands for 10 seconds. Also, when the muscles contract, they should not tighten too much, and shouldn't put pressure on themselves rather, normal contraction will be sufficient. Finally, the patient relaxes his whole body, takes 5 deep breaths, opens his eyes slowly, and returns to normal. During this period, to ensure the implementation of the relaxation technique on the prescribed days, a checklist is provided to the patient's family member to record the day, hour and duration of the technique by the patient and if not, the cause. Also, in order to solve possible problems in the implementation of the technique, during the research, the researcher made telephone calls to the patient or family member twice a week to ensure the implementation of the technique and the completion of the checklist. After 12 weeks, the researcher completes the fatigue, pain and quality of life questionnaire for the intervention group. Intervention 2: Control group: First, to start the pre-test, a questionnaire of demographic information, fatigue, pain and quality of life was completed by the researcher. This group does not receive any intervention except for routine care. The post-test is completed within 12 weeks during a telephone call by the researcher whose time and place are based on the wishes and opinions of the patient and his family. At the end of the intervention, the audio file on a CD with the researcher's own voice and an educational booklet with an image containing the first and second steps of relaxation will be provided to patients in the control group and family. 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 more information
public Mahnaz Ghaljeh
Medical Sciences Campus; Dr. Hesabi Square; Zahedan
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 public@zaums.ac.ir Zahedan University of Medical Sciences scientific Mahnaz Ghaljeh
Medical Sciences Campus; Dr. Hesabi Square; Zahedan
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 public@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age over 18 years Performing dialysis 2 to 3 times a week Ability to access and control the patient during the study Resident of Zahedan Having a cell phone by the participant or a family member or having a landline telephone at home Have a minimum degree of literacy At least 6 months have passed since the first dialysis 18 years no limit Both Need to be hospitalized Functional disability (musculoskeletal) Known mental illness Y84.1 Kidney dialysis as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Rehabilitation Rehabilitation Intervention group: First, a questionnaire of demographic characteristics, fatigue, pain and quality of life for patients is completed by the researcher. Then, the technique of progressive muscle relaxation individually face to face in 2 to 3 sessions for one hour, on the day after dialysis, the time of which is determined in coordination with the patient and family, in the presence of a first-degree member of the patient (child, spouse) is taught at the patient's home by the researcher (If the patient is not able to perform the technique independently during the designated sessions, the training will continue until the learning is complete and the technique is performed independently). The first session will be technique training; the second session will be performing the technique by the patient in the presence of the researcher and the repetition of the technique training if necessary. The third session will be training with questions from the patient and answers to his questions during practice relaxation technique at home and performance and performing technique by the patient in the presence of the researcher. The audio file is provided to the intervention group through a compact disc with the researcher's own voice and an educational booklet containing images of the first and second steps of relaxation. The intervention group is asked to do relaxation exercises twice a day (morning and evening) for 12 weeks according to the schedule set at home. Each relaxation step takes about 20 minutes. The family member is also asked to supervise the patient performing the technique at home. Prior to the intervention, the researcher will undergo theoretical and practical training in relaxation techniques in several stages under the full supervision of a clinical psychologist. The technique is performed by first closing the patient's eyes, relaxing them as much as possible, and focusing all their attention on their breathing, taking five deep breaths, and each time filling the lungs with air and empty slowly. After this stage, patients perform muscle contraction and expansion for 14 groups of facial muscles (forehead, eyelids, jaws, and lips), neck muscles, fingers and palms, forearms, arms and shoulders, back and chest, abdomen, buttock, thighs, legs and soles of the feet. Each muscle contracts for 5 seconds and expands for 10 seconds. Also, when the muscles contract, they should not tighten too much, and shouldn't put pressure on themselves rather, normal contraction will be sufficient. Finally, the patient relaxes his whole body, takes 5 deep breaths, opens his eyes slowly, and returns to normal. During this period, to ensure the implementation of the relaxation technique on the prescribed days, a checklist is provided to the patient's family member to record the day, hour and duration of the technique by the patient and if not, the cause. Also, in order to solve possible problems in the implementation of the technique, during the research, the researcher made telephone calls to the patient or family member twice a week to ensure the implementation of the technique and the completion of the checklist. After 12 weeks, the researcher completes the fatigue, pain and quality of life questionnaire for the intervention group. Control group: First, to start the pre-test, a questionnaire of demographic information, fatigue, pain and quality of life was completed by the researcher. This group does not receive any intervention except for routine care. The post-test is completed within 12 weeks during a telephone call by the researcher whose time and place are based on the wishes and opinions of the patient and his family. At the end of the intervention, the audio file on a CD with the researcher's own voice and an educational booklet with an image containing the first and second steps of relaxation will be provided to patients in the control group and family. Total fatigue score based on the fatigue questionnaire. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: The Fatigue Questionnaire is a short questionnaire to measure the level of fatigue, it consists of 9 sentences that each sentence is scored according to the severity of the symptoms. The range of scores for each question is between 7-1. Giving the lowest score, 1 indicates strong opposition to the sentence and 7 indicates strong agreement with the sentence. In order to obtain the total score of the questionnaire, the total score of each question is calculated. A higher score indicates the greater the severity of the respondent's fatigue, and vice versa. This score ranges from 9 to 63. In general, the patient with a total score below 36 indicates no fatigue and if the total score is 36 or above 36, indicates fatigue. The total pain score based on the pain questionnaire. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: Visual Analogue Scale, or VAS, is a scale used to measure pain intensity. It is the most widely used pain measuring tool in the world. The most important feature of this instrument is its ease of use. The number zero on the left indicates absolute painlessness and the number 10 on the right indicates unbearable pain. A score of 1-3 indicates mild pain, 4-7 indicates moderate pain, and 8-10 indicates severe pain. The total quality of life score that is measured by the quality of life questionnaire. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: The standard quality of life questionnaire for kidney patients is a questionnaire of 79 questions and is divided into two subscales, specific and general. General dimension includes 8 areas of general health (6 questions) with a score of 5-1, physical function (10 questions) and a score of 3-1, physical pain (2 questions) with a score of 1-1, playing an emotional role (3 questions) With a score of 2-1, social performance (2 questions) with a score of 1-1, vitality (4 questions) with a score of 6-1, mental health (5 questions) with a score of 6-1 and physical role playing (4 questions) with a score It is 2-1. Specific dimension includes 12 burden areas of kidney disease (4 questions) with a score of 1-5, cognitive function (3 questions) with a score of 1-5, quality of social interactions (3 questions) with a score of 1-5, symptoms (12 questions) with a score of 5-1, Effect of kidney disease (8 questions) with score 5-1, Sexual issues (2 questions) with score 5-1 Sleep (4 questions) with score 5-1, Social support (2 questions) with score 4-1 , Work status (2 questions) with a score of 2-1, Patient satisfaction (1 question) with a score of 1-7, Satisfaction with the care of ward staff (2 questions) with a score of 1-5 and General health rating (1 question) with a score It is 10-0. According to the standard guidelines for quality of life in kidney patients, a score of 0 to 100 is assigned for each dimension. In addition, the total scores from both subscales were classified as poor (0–33), moderate (34–66) and good above 66. General quality of life score that is measured by the quality of life questionnaire and its score range is from 0-100. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: The standard quality of life questionnaire for kidney patients is a questionnaire of 79 questions and is in 2 subscales. The general dimension includes 8 areas of general health (6 questions) with a score of 1-1, physical function (10 questions) and a score of 3-1, physical pain (2 questions) with a score of 6-1, playing an emotional role (3 questions) with a score of 2-1, social performance (2 questions) with a score of 5-1, vitality (4 questions) with a score of 6-1, mental health (5 Question) with a score of 1-6 and playing a physical role (4 questions) with a score of 1-2. According to the standard guidelines for quality of life in kidney patients, a score of 0 to 100 is assigned for each dimension. In addition, the total scores from both subscales were classified as poor (0–33), moderate (34–66) and good above 66. Specific quality of life score that is measured by the quality of life questionnaire and its score range is from 0-100. Timepoint: Before the intervention and three months after the end of the intervention. Method of measurement: The standard quality of life questionnaire for kidney patients is a questionnaire of 79 questions and is in 2 subscales, which includes a specific dimension including 12 areas of kidney disease burden (4 questions) with a score of 1-5, cognitive function (3 questions) with a score of 1-5, quality of social interactions (3 questions) with a score of 5-1, symptoms (12 questions) with a score of 1-1, the effect of kidney disease (8 questions) with a score of 1-1, sexual issues (2 questions) with a score of 1-1, sleep (4 questions) With a score of 5-1, social support (2 questions) with a score of 4-1, working status (2 questions) with a score of 1-2, patient satisfaction (1 question) with a score of 7-1, satisfaction with the care of ward staff (2 questions) ) With a score of 5-1 and the overall health rating (1 question) with a score of 10-0. According to the standard guidelines for quality of life in kidney patients, a score of 0 to 100 is assigned for each dimension. In addition, the total scores from both subscales were classified as poor (0–33), moderate (34–66) and good above 66. Zahedan University of Medical Sciences Approved 2021-03-07 Ethics Committee of Zahedan University of Medical Sciences Campus of Medical School; Dr. Hesabi square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)