Comparison of the effect of progressive muscle relaxation and physical exercises on subjective well-being and Fatigue of patients undergoing hemodialysis
Comparison of the effect of progressive muscle relaxation and physical exercises on subjective well-being and Fatigue of patients undergoing hemodialysis
Design
This study will be a two-group randomized clinical trial with a pre-test and post-test design. Using SPSS software, the sequence of allocations will be determined and will be randomly assigned to two intervention groups by even and odd time blocking
Settings and conduct
Performing progressive muscle relaxation and physical exercises in hemodialysis centers of Montaserieh and Shahrivar hospitals in Mashhad
In both groups, the intervention will be performed for 4 weeks and then the post-test with the same pre-test tools will be taken one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
6 months history of hemodialysis
• Age 18- 65 years
• Literacy for reading and writing
• Willingness to participate in the study
No visual, auditory or speech impairments
• No mental illness
• Do not have a physical disability or neuromuscular diseases or debilitating and chronic diseases
• Serious accident or bad experience in the last 6 months
• Ability to use the training file
• Not participating in a regular exercise program in the last 6 months
Do not take antidepressants and sedatives
Exclusion criteria:
• Lack of cooperation in the study
• Do not do more than 2 sessions a week
• Death of a patient or travel
• Change the dialysis center
• Kidney transplantation or the use of peritoneal dialysis
Intervention groups
First group: the Jacopsen progressive muscle relaxation technique will be taught individually in 2 face-to-face sessions for 50 to 60 minutes.
Second group: Stretching and balance exercises will be taught to the patient in one session. Then, patients will do 4 times a week (at home) using video training for 1 month
Main outcome variables
Subjective well-being - fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201227049856N1
Registration date:2021-02-15, 1399/11/27
Registration timing:registered_while_recruiting
Last update:2021-02-15, 1399/11/27
Update count:0
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
Mohammadreza Hasanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3282 9783
Email address
hasanzadehmr981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of progressive muscle relaxation and physical exercises on subjective well-being and Fatigue of patients undergoing hemodialysis
Public title
Comparison of the effect of progressive muscle relaxation and physical exercises on subjective well-being and Fatigue
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
6 months history of hemodialysis
Age 18 to 65 years
Literacy for reading and writing
Willingness to participate in the study
No vision, hearing or speech impairments
Ability to participate in interventions
Lack of mental illness
Lack of physical disability or neuromuscular diseases or debilitating and chronic diseases
No serious accidents or bad experiences in the last 6 months
Ability to use the training file
Not participating in a regular exercise program in the last 6 months
Do not take antidepressants and sedatives
Exclusion criteria:
Lack of cooperation in the study
Do not do more than 2 sessions a week
Death of a patient or travel
Change the dialysis center
Kidney transplantation or the use of peritoneal dialysis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized clinical trial of time-pair and single-group block with pre- and post-test design
Randomization unit: individually
Randomization tool: Sealed Envelopes
Random sequence construction: SPSS software
After random allocation, the allocations will be placed in sealed envelopes in order, and after selecting the research sample, it will come out of the sealed envelope and the person will be included in the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst will not be aware of the presence of patients in the intervention groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad School of Nursing and Midwifery, Doctoral Crossroads, University Street
subjective well-being of patients undergoing hemodialysis
Timepoint
Before and one month after the intervention
Method of measurement
Keyes and Magyar-moe subjective well-being questionnaire
2
Description
Fatigue
Timepoint
Before and one month after the intervention
Method of measurement
Multidimensional fatigue inventory questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group, Jacopsen's progressive muscle relaxation technique will be taught individually for 2 to 50 minutes in 2 face-to-face sessions, and a video file of relaxation movements will be provided to patients with the approval of the relevant respected consultant. People in this group will be asked to do relaxation exercises twice a day for 4 weeks, according to a set schedule during hemodialysis and at home. The researcher will examine patients each week by making a phone call or attending hemodialysis sessions.
Category
Lifestyle
2
Description
Intervention group: In the physical exercises group, first suitable stretching and balance exercises are designed under the supervision of a specialized consultant, then these exercises will be taught to the patient in one session for 50 to 60 minutes, and the video file of how to perform the exercises will be provided to patients with the approval of the relevant consultant. Will be placed. 4 sessions of 45 minutes each week (on non-hemodialysis days and on Fridays) and for 4 weeks these exercises will be performed by patients and at home. The researcher will then examine the patients each week by making a phone call or attending hemodialysis sessions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh Hospital
Full name of responsible person
Dr. Mahin Ghorban Sabbagh
Street address
in front of the Radio and Television Conference Hall، Golestan St. ، Imam Khomeini 25، Imam Khomeini St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3229 1963
Fax
+98 51 3229 1960
Email
mh.manager@mums.ac.ir
2
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Dr. Hossein Hosseinpour
Street address
Koohsangi 14,Koohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9175973884
Phone
+98 51 3840 3015
Email
١٧shahrivar_razavi.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Khalil Abnos
Street address
Deputy of Research and Technology، Gharashi Building, next to Hoveyzeh Cinema, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Hasanzadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.,, Ph.D. Intersection,University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051 38591511-3
Email
HasanzadehMR981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebe PourGhaznein
Position
Assistant Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.,, Ph.D. Intersection,University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051 38591511-3
Email
PourghazneinT@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammadreza Hasanzadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Ibn Sina St.,, Ph.D. Intersection,University St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
051 38591511-3
Email
HasanzadehMR981@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
After printing the results
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Permission from the person in charge
From where data/document is obtainable
To Mr. Mohammad Reza Hassanzadeh
HasanzadehMR981@mums.ac.ir
What processes are involved for a request to access data/document