Determining and comparing the mean total score of fatigue, pain and quality of life in dialysis patients before and three months after the implementation of progressive muscle relaxation technique in the intervention and control groups
Design
The clinical trial has a control group and parallel design and it is performed on 60 patients. Randomization will be done by card.
Settings and conduct
The above project is performed in the dialysis ward of Ali Ibn Abitaleb and Khatam Al-Anbia hospitals in Zahedan and the technique of progressive muscle relaxation is given individually to the intervention group at the patient's home by the researcher
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 18 years old referred to the dialysis ward of the relevant hospitals; suffering from chronic kidney failure; living in Zahedan; having a minimum level of education; willing to participate in the study. Non-inclusion criterion: Need to be hospitalized
Intervention groups
In the intervention group, progressive muscle relaxation technique 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). These people should do relaxation exercises twice a day (morning and evening) for 12 weeks according to the schedule set at home.
In the control group, nothing will be done except routine care.
Main outcome variables
General quality of life, quality of public life, quality of private life, fatigue, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201021049107N1
Registration date:2022-02-14, 1400/11/25
Registration timing:registered_while_recruiting
Last update:2022-02-14, 1400/11/25
Update count:0
Registration date
2022-02-14, 1400/11/25
Registrant information
Name
Mojtaba Kazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5772 5390
Email address
kazaeim2@moums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2022-03-11, 1400/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive muscle relaxation technique on fatigue, pain and quality of life patients undergoing dialysis
Public title
The effect of progressive muscle relaxation technique on fatigue, pain and quality of life of dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Need to be hospitalized
Functional disability (musculoskeletal)
Known mental illness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Campus of Medical School; Dr. Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.ZAUMS.REC.1399.539
Health conditions studied
1
Description of health condition studied
Dialysis patients
ICD-10 code
Y84.1
ICD-10 code description
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
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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.
5
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital; Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Street address
Ali Ibn Abitaleb Hospital; Salamat Boulevard; Khalij-e-Fars Highway; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
ghaljeh.m@gmail.com
2
Recruitment center
Name of recruitment center
Khatam Al-Anbia Hospital, Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Street address
Khatam Al-Anbia Hospital; Khatam Square; Jam Jam Boulevard; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3322 0501
Email
ghaljeh.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noor Mohammad Bakhshani
Street address
Campus of Medical School; Dr. Hesabi square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
+98 54 3337 2116
Email
public@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
University faculty member, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus; Dr. Hesabi Square; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
University faculty member, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus; Dr. Hesabi Square; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahnaz Ghaljeh
Position
University faculty member, assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus; Dr. Hesabi Square; Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available