The present clinical trial was conducted on 62 family caregivers who had the primary responsibility of taking care of the patients with spinal cord injury. The participants were randomly divided into intervention (n=33) and control groups (n=29). The intervention group was involved in 90-minute educational sessions held once a week for four weeks. Both groups completed SF-36 questionnaire before and 2 and 6 weeks after the intervention. Then, the data were analyzed through independent t-test, Chi-square, and repeated measures ANOVA tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070811388N2
Registration date:2013-07-20, 1392/04/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-20, 1392/04/29
Registrant information
Name
Taybeh Falahati
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4251
Email address
falahatit@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellar for research of Shiraz University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation The effect of psycho-educational interventions on quality of life of family caregivers
Public title
The effect of psycho-educational interventions on quality of life of family caregivers of patient with spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The individuals who had been the primary caregiver of a patient for one year and were willing to take part in the study were recruited into the research. Having access to telephone. Exclusion criteria of the study were having a history of hospitalization, suffering from known mental disorders, and being under treatment by psychiatric medications.
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz, Zand street
City
Shiraz
Postal code
71345-1978
Approval date
2012-10-07, 1391/07/16
Ethics committee reference number
91/6266
Health conditions studied
1
Description of health condition studied
Spinal cord injury
ICD-10 code
G90-G99
ICD-10 code description
Other disorders of the nervous system
Primary outcomes
1
Description
Quality of life
Timepoint
Before, two & six weeks after the end of study
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
No intervention in control group
Category
Other
2
Description
Psycho-educational intervention for intervention group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatholmobine Welfare center of Shiraz
Full name of responsible person
Ms.Ebrahimi
Street address
Shiraz, Cuie Zahra
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellar for research of Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
91/243010
Grant code / Reference number
91/6266
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellar for research of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Zahra Molazem
Position
PH.D, faculty member, Nursing Department
Other areas of specialty/work
Street address
Nursing & midwifery school, Zand Street
City
Shiraz
Postal code
13119-71936
Phone
+98 71 1647 4251
Fax
+98 64 74252
Email
molazemzah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Zahra Molazem
Position
PH.D, faculty member, Nursing Department
Other areas of specialty/work
Street address
Nursing & midwifery school, Zand Street
City
Shiraz
Postal code
13119-71936
Phone
+98 71 1647 4251
Fax
+98 64 74252
Email
molazemzah@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Taybeh Falahati
Position
Postgraduate nursing student
Other areas of specialty/work
Street address
Nursing & midwifery school, Zand Street
City
Shiraz
Postal code
13119-71936
Phone
+98 71 1647 4251
Fax
+98 64 74252
Email
falahatit@sums.ac.irtaybehfalahati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)