Protocol summary

Summary
This research was a clinical trial which was done on 72 family caregivers of patients with spinal cord injury who had referred to Fatholmobine welfare center of Shiraz city.Caregivers were selected with convenient sampling then randomized to experimental & control groups.Caregivers of experimental group participated in psycho-educational interventions program but caregivers of control group didn't participate in this program. psycho-educational intervention 4 session were performed one day a week, each session would 90 min. The purpose of this study was determining & comparing caregivers mental health before, two & six weeks after execution of psycho-educational interventions program in intervention & control group and between groups.The data were collected by GHQ-28 questionnaire which completed by caregivers of both groups before, two & six weeks after executing psycho-educational interventions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012110611388N1
Registration date: 2013-03-24, 1392/01/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-24, 1392/01/04
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 chancellor 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 of effect of psycho-educational interventions on mental health of family caregivers of patient with spinal cord injury
Public title
The effect of psycho-educational interventions on mental health of family caregivers of patient with spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Having the primary role of caregiver, Responsible for caregiving of patient with SCI over a year, Having access to telephone ,Having the tendency to participate in the study. Exclusion criteria: Having history of identified mental disorder or hospitalization and use psychotropic drugs.
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
Mental health
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
N/A

2

Description
The psycho-educational intervention that was performed in this research consisted of four consecutive weekly sessions, each session would 90 min. Providing information about strategies of coping with stress & depression, teaching effective communication, strategies of coping with crisis, teaching proper cares of patient with spinal cord injury.
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 71 1647 4252
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 71 1647 4252
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 71 1647 4252
Email
taybehfalahati@yahoo.comfalahatit@sums.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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