This study aims to determine the effect of self-efficacy training using the Bezenef model on the quality of life of patients with Spinal cord injury will be done in Rafidah Rehabilitation Hospital in 1402.
Design
The selection of participants will be available and the patients with SCI hospitalized in Rafideh Rehabilitation Hospital in 1402 will be included in the study. In order to prevent the participants of the two intervention and control groups from contacting each other, sampling will be done asynchronously and at two separate times.The samples are randomly divided into two intervention and control groups of 40 people
Settings and conduct
This study will be conducted in Rafidah Rehabilitation Hospital.
Participants/Inclusion and exclusion criteria
Entry conditions: age >20, not participating in similar educational programs, no history of brain disorder, no pressure ulcer and mental disorders, access to the Internet and messengers, history of spinal cord injury for six months or more.
Conditions of non-entry: unwillingness to participate in the study, use of psychoactive drugs and neuropsychiatric drugs, causing complications that the patient is unable to continue participating in the test.
Intervention groups
Completion questionnaires in the intervention and control groups. For the intervention group, it includes self-efficacy training based on the steps of the Bezenef model according to the training program designed in 7 sessions of 60 minutes for 6 weeks, in the form of group sessions, with the active participation of the patient and one of the The family members will be interviewed by the researcher in the conference hall of the center using educational aids. Also, the implementation of routine treatments . In both The telephone counseling group will be accepted immediately.
Main outcome variables
Change in the quality of life and self-efficacy of people with spinal cord injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230529058326N1
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
zohreh karimi oragh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5633 0177
Email address
zohrehkarimi0211@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-efficacy training using the BASNEF model method on the quality of life of patients with spinal cord injury
Public title
Effect of self-efficacy training using the BASNEF model method on the quality of life of patients with spinal cord injury
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
history of spinal cord injury for six months or more
Age above 20 years
Failure to participate in similar educational programs
No history of brain disorder or disease such as stroke
Absence of pressure sores
Internet access and messengers
Not suffering from mental disorders (according to the initial consultation)
Exclusion criteria:
Unwillingness to participate in the study
Use of psychoactive drugs and neuropsychiatric drugs
causing complications that make the patient unable to continue participating in the test
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization will be done by block method using Graphpad software and concealment will be done by SPONE method.
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
Ethics committee in research of pharmacy, nursing and midwifery faculties of SBMU
Street address
Valiasr Ave
City
Tehran
Province
Tehran
Postal code
0000000000
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.011
Health conditions studied
1
Description of health condition studied
Spinal Cord Injury
ICD-10 code
T09.3
ICD-10 code description
Injury of spinal cord, level unspecified
Primary outcomes
1
Description
Quality Of Life
Timepoint
7 weeks
Method of measurement
SIP-68 Quality Of Life Questionnaire
Secondary outcomes
1
Description
Self-Efficacy
Timepoint
7 weeks
Method of measurement
GSE-17 Sherer Self-Efficacy
Intervention groups
1
Description
Intervention group: Questionnaires will be filled before the intervention to be compared at the end of the study when they are filled again. The self-efficacy training intervention is based on the steps of the Bezenf model and will be implemented according to the designed training program in 7 60-minute sessions with the titles of reforming ideas, attitudes, mental norms 1 and 2, enabling factors, behavioral intention and behavioral structures. Training includes definitions, goals, disease complications, prevention, treatment, diet, physical activity, self-care, lifestyle improvement, anxiety and stress control, problem solving and adaptation, etc.
Category
Behavior
2
Description
Control group: The control group will fill the questionnaires 2 times with an interval of 7 weeks and will receive only routine care in the meantime.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rofaydeh Rehabilitation Hospital
Full name of responsible person
Fatemeh Neiseh
Street address
Rofaydeh hospital, Andarzgoo Ave
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8865 5366
Email
sarah.neiseh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Sepideh Hajian
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
Hajian74@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Neiseh
Position
0
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8865 5366
Email
sarah.neiseh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Neiseh
Position
0
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8865 5366
Email
sarah.neiseh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Neiseh
Position
0
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8865 5366
Email
sarah.neiseh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
0
When the data will become available and for how long
0
To whom data/document is available
0
Under which criteria data/document could be used
0
From where data/document is obtainable
0
What processes are involved for a request to access data/document