aim :This research aims to determine the effect of self-management program on self-efficacy and life satisfaction of patients with spinal cord injury (SCI). Design: This research is a randomized clinical trial study do on 66 patients with SCI. Population: The study populations include patients with spinal cord injury patients referred to the Iran Spinal Cord Disability Support Center and eligible to enter the study. Inclusion criteria: Aged 65-18 years; history of spinal cord injury from 3 months to 6 years; Spinal cord injury leading to paraplegia; not having trouble communicating (like deafness and blindness); Making phone calls. Exclusion criteria: Unwilling to participate in the study; the deterioration of the patients' condition prevents them from participating in the program. Method: The available sampling is done among Spinal Cord Injury patients referred to the Iran Spinal Cord Disability Support Center base on inclusion criteria. Then, random allocation of patients is done in two groups of intervention and control using random numbers. Intervention: The control group receive routine care. For the intervention group, self-management program is implement based on five self-management skills. Patients in both groups will complete moorong self-efficacy (MSES) and life satisfaction (SWLS) questionnaires before intervention. In intervention group, self-management sessions will be performed in 4 sessions of 2 hour, two session a week. After completing the intervention, a follow-up program is conducted for 12 weeks each week by the researcher for samples. Main outcome measures (variables): self-efficacy and life satisfaction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710306314N3
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Soraya Nejati
Name of organization / entity
Tehran University Medical of Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 0711
Email address
nejatiso@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management program on self-efficacy and life satisfaction of patients with spinal cord injury (SCI)
Public title
The effect of self-management program on self-efficacy and life satisfaction of patients with spinal cord injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 65-18 yrs, The history of spinal cord injury from 3 months to 6 yrs; Spinal cord injury leading to paraplegia; Not having trouble communicating (like deafness and blindness; Making phone calls.
exclusion criteria: Unwilling to participate in the study; The deterioration of the patients' condition prevents them from participating in the program.
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:
66
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
Ethicsl Commitee of Tehran Faculty of Nursing and Midwifery and rehabilitation
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Postal code
Approval date
2016-12-27, 1395/10/07
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1328
Health conditions studied
1
Description of health condition studied
spinal cord injury
ICD-10 code
G95.2
ICD-10 code description
Cord compression, unspecified
Primary outcomes
1
Description
self-efficacy
Timepoint
Before the intervention, one month and three months after the end of the intervention
Method of measurement
Morong Self-Efficacy Questionnaire (MSES)
2
Description
Satisfaction of life
Timepoint
Before the intervention, one month and three months after the end of the intervention
Method of measurement
Life satisfaction questionnaire (SWLS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: : The control group receive routine care.
Category
N/A
2
Description
For the intervention group, self-management program is implement based on five self-management skills, including: 1. Problem-solving skills. 2. Decision-making skills. 3. Use of resources. 4. Formation of therapeutic communication between caregiver and patient. 5. Operational program. In intervention group, self-management sessions will be performed in 4 sessions of 2 hour, two session a week.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Spinal Cord Disability Support Center
Full name of responsible person
Masoumeh Taghizadeh
Street address
Rehabilitation and Educational Center for Spinal Cord Injury Shohada Jalayipour, Fire Department Street, behind the Shahid Akbar Abadi Hospital, Mowlavi Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraiyan
Street address
Central building of Tehran University of Medical Sciences, Qhds street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Taghizadeh
Position
Msn student in Medical-Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
mtaghizadeh026@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Soraya Nejati
Position
Lecturer
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid Square, Tehran
City
Tehran
Postal code
Phone
+98 61054317
Fax
Email
nejatiso@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery,Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Taghizadeh
Position
Msn student in Medical-Surgical Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Nosrat Sharghi Street, Tohid square,Tehran
City
Tehran
Postal code
Phone
+98 21 6633 3091
Fax
Email
mtaghizadeh026@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)