Protocol summary
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Study aim
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evaluate the effect of Benson relaxation on fatigue, depression and daily activities in hemodialysis patients.
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Design
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This study was a clinical trial with control group with parallel design. The sample size of 65 patients was randomly divided into two equal groups.
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Settings and conduct
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Vasei Hospital in Sabzevar
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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, Beck depression and Nottingham Questionnaire 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.
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Main outcome variables
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Fatigue, depression and daily activities
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014011115393N2
Registration date:
2014-01-19, 1392/10/29
Registration timing:
registered_while_recruiting
Last update:
2019-05-19, 1398/02/29
Update count:
1
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Registration date
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2014-01-19, 1392/10/29
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Sabzevar University of Medical Sciences
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Expected recruitment start date
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2013-12-31, 1392/10/10
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Expected recruitment end date
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2014-03-20, 1392/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of benson relaxation on fatigue, depression and Daily Activities in hemodialysis patients
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Public title
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Effect of benson relaxation on fatigue, depression and Daily Activities
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
Kidney transplant
Death
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
65
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation with random numbers
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2013-12-06, 1392/09/15
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Ethics committee reference number
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92.7.medsab.Rec
Health conditions studied
1
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Description of health condition studied
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End stage renal failure
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ICD-10 code
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N18.9
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ICD-10 code description
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Chronic kidney disease, unspecified
Primary outcomes
1
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Description
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Fatigue in hemodialysis patients
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Timepoint
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before, 2week and 4 week after intervention
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Method of measurement
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Brief Fatigue Inventory (BFI), Beck Depression and Nottingham
Intervention groups
1
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Description
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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), Depression and daily activities 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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sabzevar University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available