Protocol summary

Summary
Hemodialysis is the most common medical management of patients affected by End-stage renal disease. For hemodialysis to be successful, strict fluid compliance and weight control is mandatory. Education, in terms of self-care activities, is an important intervention for improving patients’ outcomes in this disease. Self-efficacy promotion program training is an effective strategy for behavioral change. The aim of this study was to investigate the effect of a self-efficacy promotion program on the body weight changes in patients undergoing hemodialysis. Methods: In this single-blind quasi-experimental study, we recruited a convenience sample of 63 patients undergoing hemodialysis from two teaching hospitals and allocated them randomly to the experimental or control group. Patients in the experimental group received a 6-session Self-efficacy promotion program training while the control group received the routine care of the institute. Mean body weight gain and self-efficacy were measured before, immediately and two months after the study. Findings: the groups did not differ significantly regarding the study variable before the study. However, immediately and two months after the study, the mean body weight gain and self-efficacy in the experimental group were significantly lower and higher, respectively, than the control group (P< 0.05). Conclusion: implementing the Self-efficacy promotion program training is effective in decreasing weight gain and increasing self-efficacy in patients undergoing hemodialysis. Nurses in hemodialysis ‌units can use Self-efficacy promotion program training as an effective intervention for improving patients’ outcomes. Inclusion criteria: 1) age between 18-65 years 2)able to speak Persian or Turkish 3) at Least one years haemodialysis 4) no physical limitation in self-care 5) Receiving routine haemodialysis three times in week of four hours Exclusion criteria 1-no psycholosical or cognitive disorders. 2- no affected to congestive heart failure ,no affected to cirrhosis of the Liver.

General information

Acronym
selfefficacy
IRCT registration information
IRCT registration number: IRCT138805032226N1
Registration date: 2012-04-27, 1391/02/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-27, 1391/02/08
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2009-11-07, 1388/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of self efficacy training on wight alteration hemodialysis patients
Public title
self efficacy training and wight alteration hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) age between 18-65 years 2)able to speak Persian or Turkish 3) at Least one years haemodialysis 4) no physical limitation in self-care 5) Receiving routine haemodialysis three times in week of four hours Exclusion criteria 1-no psycholosical or cognitive disorders. 2- no affected to congestive heart failure ,no affected to cirrhosis of the Liver.
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: 104
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
Ethics committee nursing&midwifery Tehran University of Medical Sciences
Street address
squar toohid-nursing&midwifery facultyTehran University of Medical Sciences-tehran-iran
City
Tehran
Postal code
1419733171
Approval date
2009-06-19, 1388/03/29
Ethics committee reference number
305/250/د

Health conditions studied

1

Description of health condition studied
Weight alteration haemodialysis patients
ICD-10 code
N18.9
ICD-10 code description
Chronic kidney disease, unspecified

Primary outcomes

1

Description
Self efficacy training reduce to weight control patients 1-2 kg during heamodialyis sessions
Timepoint
3 times in week
Method of measurement
Measurment of the patients weight by scale

Secondary outcomes

empty

Intervention groups

1

Description
In interventionall group questionnaires at the beginning, a month later and was completed two months later.Intervention (teaching efficacy) in this group was done.
Category
Prevention

2

Description
In control group questionnaires at the beginning, a month later and was completed two months later.Intervention (teaching efficacy) in this group was not done.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Beheshti & Valiasre hospital of zanjan university of medical sciences
Full name of responsible person
mansooreh aliasgarpour
Street address
Tehran University of Medical Sciences
City
zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
nursing&midwifery faculty -Tehran University of Medical Sciences
Full name of responsible person
Dr Reza Negarandeh
Street address
nosrat East street-squar toohid-nursing&midwifery faculty - Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
nursing&midwifery faculty -Tehran 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
nursing&fmidwifery aculty - Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
academic member
Other areas of specialty/work
Street address
nosrat East street- square toohid-nursing&midwifery faculty- Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 66937120
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
nursing& midwiferyfaculty - Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
academic member
Other areas of specialty/work
Street address
nosrat East street-squar toohid-nursing&midwifery faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 66937120
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
nosrat East street-nursing& midwifery faculty - Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
academic member
Other areas of specialty/work
Street address
squar toohid-nursing& midwifery faculty - Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 66937120
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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