This randomized control clinical trial will be conducted on 65 hemodialysis patients in Vasei hospitals in Sabzevar. This study is planned to evaluate the effect of Benson relaxation on fatigue and depression in hemodialysis patients. the trail will be performed in 65 patients between 18 to 65 years of age Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease Exclusion criteria: Reluctance to continue participating in the exercises; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Kidney transplant; Death . After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month. No intervention will be made in control group. Brief Fatigue Inventory (BFI) questionnaire and Beck depression questionnaire will complete by all patients before and 2 week and 4 week after intervention. In cases that the patients can't able to read or write, the researcher will complete the questionnaire based on exact patient's statements.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014011115393N2
Registration date:2014-01-19, 1392/10/29
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2014-01-19, 1392/10/29
Registrant information
Name
Narjes Heshmati Far
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
nheshmatifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2013-12-31, 1392/10/10
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of benson relaxation on fatigue and depression in hemodialysis patients
Public title
Effect of benson relaxation on fatigue and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged between 18 to 65 years; History of hemodialysis more than 6 months; Patients with dialysis charts in the hemodialysis centers and regular referring to the centers; Absent of disability or chronic disease
Exclusion criteria: Reluctance to continue participating in the exercises; Presence of disability or chronic disease, Except diabetes or hypertension; Dieing the patient; Kidney transplant; Death
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
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
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2013-12-06, 1392/09/15
Ethics committee reference number
92.7.medsab.Rec
Health conditions studied
1
Description of health condition studied
End stage renal failure
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified
Primary outcomes
1
Description
Fatigue in hemodialysis patients
Timepoint
before, 2week and 4 week after intervention
Method of measurement
Brief Fatigue Inventory (BFI)
Secondary outcomes
empty
Intervention groups
1
Description
After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups: 33 patients in experimental and 32 in control group. The experimental group will receive supportive intervention and get education of Benson relaxation with video tape and every patient will get one CD and pamphlet for use in home. Patients in experimental group will do Benson relaxation for 15 minute, twice a day during one month.Brief Fatigue Inventory (BFI) questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements.
After approving of the study by sciences vice chancellor of Sabzevar University of medical sciences and completing of written consent form by all participants in the study, patients will be divided randomly into two equal groups:33 patients in experimental and 32 in control group.NO intervention in control group. Brief Fatigue Inventory (BFI) questionnaire will complete by experimental group before, 2 week and 4 week after intervention. the researcher will complete the questionnaire based on exact patient's statements.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Vasei hospital
Full name of responsible person
Mehran Hosseini
Street address
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Name of organization / entity
Sabzevar University of Medical Science
Full name of responsible person
Narjes Heshmatifar
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 915 174 1810
Fax
Email
nheshmatifar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Scinces
Full name of responsible person
Mohsen Koushan
Position
MSc./Member of Faculty
Other areas of specialty/work
Street address
Sabzevar University of Medical Science
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
mkoushan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Scinces
Full name of responsible person
Narjes Heshmati Far
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
00
Fax
Email
nheshmatifar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)