Objective: This study was conducted aimed at determining the effect of quality of life training on self-efficacy of patients under hemodialysis treatment.
Procedure: This research is a clinical trial. The Sample consists of 90 subjects (two groups, 45 subjects each), who were selected at random from among patients referring to dialysis centers of the city of Kerman.
Participants’ inclusion and exclusion major eligibility criteria:
Inclusion criteria were: At least 6 months ought to be passed from the start of their dialysis; have no history of mental health diseases and problems; have no physical problem other than chronic kidney disease; do not have a history of kidney transplantation.
Exclusion criteria were: The subject’s intention to undergo a kidney transplant and intention to emigrate and his/her suffering from acute physical and psychological problems during the intervention and implementation of the study plan
Intervention: Both groups took the first round test. In the study group, quality of Life training program was implemented in the forms of speech, question and answer and giving educational pamphlets in sessions, 45 min each, while the time interval between two consecutive sessions was 10 min. Two months after the first test, the second test was conducted for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061513677N1
Registration date:2013-11-22, 1392/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-22, 1392/09/01
Registrant information
Name
Somayeh Soltani Nejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3366 5500
Email address
s.soltaninejad@iauba.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Bandar abbas Branch
Expected recruitment start date
2011-10-16, 1390/07/24
Expected recruitment end date
2012-03-14, 1390/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of quality of life training on self-efficacy of patients under hemodialysis treatment
Public title
Effect of quality of life training on self-efficacy hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The subjects ought to be older than 18 years; at least 6 months have been passed from their start of dialysis; have a minimum level of literacy (reading and writing); be willing to participate in the investigation; have no history of mental health problems, suffer from no physical problem other than chronic kidney disease; do not have a history of kidney transplantation; have not participated in other similar studies.
Exclusion criteria: Intending to undergo a kidney transplant and emigration during the intervention and implementation of the study plan; suffering from acute physical and psychological problems during the study plan.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Taking note of the criteria of the study, 90 subjects were selected and were divided into two groups after casting lots, each consisting of 45 subjects.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bandar Abbas University of Medical Sciences
Street address
Islamic Azad University Campus, Universities Blvd, Bandar abbas
City
Bandar abbas
Postal code
7915893144
Approval date
2011-10-02, 1390/07/10
Ethics committee reference number
518660/11/15
Health conditions studied
1
Description of health condition studied
End stage renal disease treat with hemodialysis
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Self-efficacy
Timepoint
Before and 2 months after intervention
Method of measurement
Strategies used by people to promot health questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and 2 months after intervention
Method of measurement
The world health organization quality of life (WHOQOL) -BREF questionnaire
Intervention groups
1
Description
A Pamphlet in (physical, mental, social, and family) dimensions was prepared and was approved by 10 authoritative instructors from various departments of nursing, medicine and the nephrologist. During three 45-minute sessions with an interval of 10 days between any two of them, training was given individually in the form of speech, and questions and answers were given individually, too.
Category
Behavior
2
Description
The control group received no intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specific Diseases Center
Full name of responsible person
Mrs. Fatemeh Hosseini
Street address
Shahid Rajai St ,Kerman
City
Kerman
2
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mrs. Ashraf Haghdoost
Street address
Shafa Blvd, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Islamic Azad University Bandar abbas Branch
Full name of responsible person
Dr. Mohsen Dehghani
Street address
Islamic Azad University Campus, University Blvd, Bandar abbas
City
Bandar abbas
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, Islamic Azad University Bandar abbas Branch
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
Islamic Azad University Bandar abbas Branch
Full name of responsible person
Somayeh Soltani Nejad
Position
MSc in nursing - Faculty member
Other areas of specialty/work
Street address
Islamic Azad University Campus, University Blvd, Bandar abbas
City
Bandar abbas
Postal code
7915893144
Phone
+98 76166655004
Fax
+98 66702486665510
Email
s.soltaninejad@iauba.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Bndar abbas Branch
Full name of responsible person
Somayeh Soltani Nejad
Position
MSc in nursing - Faculty member
Other areas of specialty/work
Street address
Islamic Azad University Campus, University Blvd, Bandar abbas
City
Bandar abbas
Postal code
7915893144
Phone
+98 76166655004
Fax
+98 66702486665510
Email
s.soltaninejad@iauba.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Bandar abbas Branch
Full name of responsible person
Somayeh Soltani Nejad
Position
MSc in nursing- Faculty member
Other areas of specialty/work
Street address
Islamic Azad University Campus, University Blvd, Bandar abbas
City
Bandar abbas
Postal code
7915893144
Phone
+98 76166655004
Fax
+98 66702486665510
Email
s.soltaninejad@iauba.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)