This study will be done with aim to investigation of effectiveness and non-effectiveness of progressive muscle relaxation technique on fatigue in hemodialysis patients. The study population will be included all patients undergoing hemodialysis referring to Imam Reza Hospital of Kermanshah city. The number of 60 eligible patients will selected and randomly will assigned to two experimental and control groups. Beginning of the study, BFI fatigue checklist will be provided for both groups. Then a relaxation CD derived from Relax in depth book that is written by Bahadurani and Poornaseh, will be put to the experimental group. Each relaxation step lasts about 15 minutes. Relaxation technique is taught to the patient during two consecutive sessions and the patients will be asked to do relaxation exercises at home according to the set out schedule, 2 times a day for 30 days; That means a time of relaxation be before the main bedtime. No special intervention will be done in the control group and routine process will be carried out. At the end of the study BFI fatigue checklist will be provided for both groups and both groups are compared.
Inclusion criteria: Hemodialysis for at least 6 months; Age above 15 years; Having full consciousness.
Exclusion criteria: Failure to do trained relaxation program schedule.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092514333N59
Registration date:2016-10-31, 1395/08/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of effectiveness of progressive muscle relaxation technique on fatigue in hemodialysis patients
Public title
Effect of progressive muscle relaxation technique on fatigue in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hemodialysis for at least 6 months; Age above 15 years; Having full consciousness; Listening and speaking ability for learning relaxation technique; no known mental illness.
Exclusion criteria: Failure to do trained relaxation program schedule; Hospitalization from any cause during the study
Age
From 15 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
kums.rec.1395.53
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
N18
ICD-10 code description
Chronic renal failure
Primary outcomes
1
Description
Fatigue
Timepoint
Baseline, the end of the study (a month later)
Method of measurement
BFI fatigue checklist
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will do the relaxation exercises at home according to the set out schedule, 2 times a day for 30 days
Category
Behavior
2
Description
No special intervention will be done in the control group and routine process will be carried out
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Fereshteh Jalalvandi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Hadaddin
Position
Master of Nursing, Internal Surgical trends
Other areas of specialty/work
Street address
School of Paramedical Sciences, Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
F.Hadadian@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fereshteh Jalalvandi
Position
Msc. of Surgical Internal Nursing
Other areas of specialty/work
Street address
School of Paramedical Sciences, Dolatabad Boulvard, Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
fjalalvandi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)