Patients undergoing haemodialysis experience many changes in their quality of life. Despite of these changes they should actively manage their clinical problems for which they are not prepared. The aim of this quasi-experimental study was to determine the impact of empowerment on the quality of life, self efficacy, clinical and laboratory indicators of patients under hemodialysis.
Subjects participated in this interventional study were 48 patients treated with haemodialysis at least for 3months who referred to Boo Ali Sina dialysis center located at Shiraz-in the south of Iran .Quality of life, self efficacy, clinical and laboratory indicators of all patients were measured by questionnaire ,interview and lab tests. Then they were randomly divided into two equal groups as control & experimental groups. In the next stage the experimental group participated in a 6 week empowerment program in which self management was enhanced by individual & group counselling. Quality of life, self efficacy, clinical and laboratory indicators in both groups were assessed 6 weeks after the implementation of intervention as post-test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901172621N4
Registration date:2011-05-19, 1390/02/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-19, 1390/02/29
Registrant information
Name
Marzieh Moattari
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
moattarm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-09-29, 1388/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment on quality of life, self efficacy and clinical and lab indicators of patients under hemodialysis treatment
Public title
The effect of empowerment on quality of life of paitents under hemodialyse
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:1-18-60 year old 2-abilityto read and write 3- three times dialysis in a week 4-giving permission to participate in the study 5-living in Shiraz 6-living along with family members7-able to walk & eat without help 9-being under haemodialysis at least for three months. Exclusion criteria: lack of interest to continue hospitalization due to acute illness during the study diagnosed as having mental disorder being in waiting list for transplantation
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:
48
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
Shiraz univercity of medical sciences
Street address
Zand blvd
City
Shiraz
Postal code
Approval date
2009-11-01, 1388/08/10
Ethics committee reference number
ct-88-4785
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
quality of life
Timepoint
before and 6 weeks after intervention
Method of measurement
Questionnaire
2
Description
clinical indicators
Timepoint
before and 6 weeks after intervention
Method of measurement
paitent chart
3
Description
lab indicators
Timepoint
before and 6 weeks after intervention
Method of measurement
paitent chart
4
Description
self efficacy
Timepoint
6 weeks after intervention
Method of measurement
questionaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention program consisted of two parts including individual and group counselling for 6 weeks. Individual counselling focused on educating, supporting and helping patients develop skills and self-awareness in problem identification, exploration of emotions associated with these problems, goal setting, problem solving and self-management through strategies to overcome the identified problems and achieving the goals, and making behavioural change.. In group counselling, the patients, attended in two small group sessions of 1.5-2 hours conducted by a psychiatric nurse for stress management, coping strategies, social support and motivation.this program offered just to the expermental group.
Category
Behavior
2
Description
The control group received the conventional information avilableat the center.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali sina hospital
Full name of responsible person
Mr Rasti
Street address
Sadra city
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz Univercity of Medical Sciences
Full name of responsible person
Dr. Dabaghmanesh
Street address
Vice Chancellor for Research, 7th floor, Shiraz Univercity of Medical Sciences, Zand st
City
Shiraz
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, Shiraz Univercity 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
Shiraz Univercity of Medical Sciences
Full name of responsible person
Marzieh Moattari
Position
PHD in Nursing, Faculty Member
Other areas of specialty/work
Street address
Departmant of Graduate Studies, Fatemeh School of Nursing & Midwifery, Zand blvd
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
+98 71 1647 4251
Email
moattari@yahoo.com , moattarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Univercity of medical sciences
Full name of responsible person
Marzieh Moattari
Position
PHD in Nursing, Faculty Member
Other areas of specialty/work
Street address
Departmant of Graduate Studies, Fatemeh School of Nursing & Midwifery, Zand blv
City
Shiraz
Postal code
Phone
+98 71 1627 9131
Fax
+98 71 1647 4256
Email
moattari@yahoo.com , moattarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz Univercity of Medical Sciences
Full name of responsible person
Marzieh Moattari
Position
PHD in Nursing, Faculty member
Other areas of specialty/work
Street address
Departmant of Graduate Studies, Ftemeh School of Nursing & Midwifery, Zand blvd
City
Shiraz
Postal code
Phone
+98 71 1647 4251
Fax
+98 71 1647 4251
Email
moattarm@sums.ac.ir , moattari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)