Determining the effect of narrative therapy on psychological cohesion and social stigma associated with traumatic spinal cord injury
Design
The type of randomized controlled trial will be without blinding in which there will be an experimental group and a control group. The design of the present study will be a parallel design with the control group with random assignment of subjects. Taking into account fifteen ten percent loss, we consider at least 16 samples in each group before and after the intervention.
Settings and conduct
After obtaining the code of ethics and permission from the university, he will refer to the research environment and take samples from the officials of the research environment. Then, by installing a call in the research environment, patients with traumatic SCI are invited to cooperate. For patients who wish to participate in the study, the goals of work will be explained and written consent will be obtained from them. Sampling will be done by available method Sampling will be done by available method. Then the samples will be randomly divided into two group The members of the experimental group will then receive the treatment narrative , but the members of the control group will not receive any advice. At the end of the sessions, members of both groups will complete the questionnaires
Participants/Inclusion and exclusion criteria
Willingness to participate in the study
Literacy
Age 18 years and older
No mental illness
Intervention groups
Intervention group: The effectiveness of narrative therapy on psychological cohesion and social stigma of spinal cord injury patients, which will be done within a month (8 sessions) - Control group: do not receive any psychotherapy
Main outcome variables
sense of coherence-
social stigma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220619055214N1
Registration date:2022-06-25, 1401/04/04
Registration timing:prospective
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Mahtab Razavinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 8219
Email address
razavi73@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-01, 1401/04/10
Expected recruitment end date
2022-08-02, 1401/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group narrative therapy on sense of coherence and social stigma associated with traumatic spinal cord injury
Public title
Investigating the effect of biography on psychological integration and social stigma of Patients with paralysis of the spinal cord
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Be literate
Age 18 years and older
Exclusion criteria:
No serious illness other than spinal cord injury
No mental illness
Lack of individual and group counseling and psychotherapy sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in this study is done in a simple random method - lottery - first the names of people who have the conditions to enter and wish to participate in order to make a random allocation on a sheet of paper is written then each patient is assigned a code in the next step In order to have the same chance in each person, the names of the people in the wheel (or any similar method) are poured and selected by a third party.
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 of Islamic Azad University of Isfahan (Khorasgan)
Street address
University Blvd, Arghavanieh , East Jay St , Isfahan
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2022-05-01, 1401/02/11
Ethics committee reference number
IR.IAU.LKHUISF..REC.1401.024
Health conditions studied
1
Description of health condition studied
Patients with traumatic spinal cord injury (Paraplegia)
ICD-10 code
G82.2
ICD-10 code description
Paraplegia
2
Description of health condition studied
Patients with traumatic spinal cord injury( Quadriplegia)
ICD-10 code
G82.5
ICD-10 code description
Quadriplegia
Primary outcomes
1
Description
Evaluation of the effect of group narrative therapy on psychological cohesion related to spinal cord traumatic injury --- Mental cohesion score in Flensberg questionnaire
Timepoint
Measurement of psychological cohesion (before the intervention) and one month after the intervention
Method of measurement
Flensberg Questionnaire
2
Description
The effect of group narrative therapy on social stigma associated with traumatic spinal cord injury --- Social stigma score in the social stigma questionnaire after spinal cord injury
Timepoint
Measurement of social stigma (before the intervention) and one month after the intervention
Method of measurement
Social Stigma Questionnaire after spinal cord injury
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The treatment protocol of narrative therapy sessions will be performed in two sessions per week and in 8 90-minute sessions in a group manner in the counseling room of Tabriz Welfare Office according to the treatment plan of Michael White and Epston 1 (1990). The description of the narrative-therapy sessions will be as follows: Session 1: Introduction, presentation of intervention schedule, number of sessions, time interval of sessions, expectations from the group, introduction of skills, goal statement, comprehensive evaluation, creating a good relationship, familiarity with narrative therapy, work sample, life narration and storytelling; Second: Objectification and externalization of the problem, naming the problem, identifying the problematic words and beginning of metaphorization ; From the problem by the exceptions of life, narrative analysis, attitudes toward the problem and the interactions between the individual and the problem; Session 5: Reconstruction stage: new metaphors, mental representations of life situations with new metaphor, creation of reality by the individual and the beginning of narration; Session 6: Enrichment of the new story using unique strategies, examining the story and its meaning to the future; : Living in a new story, answering questions and rewriting past stories; Session 8: Examining the meaning of life, external documentation, enriching and encouraging the person to continue the story, post-test and end of treatment Prior to randomization and intervention, all samples will complete the research questionnaires in order to ensure the same chance of selection in each individual. Then, the members of the experimental group will receive the narrative-therapy narrative as a group by the researcher in 8 sessions of 1.5 hours (2 months). After the sessions, they will complete the questionnaire of psychological cohesion and social stigma again. This (post-test implementation) will be done to evaluate the effectiveness of the independent variable (narrative therapy) on the dependent variables (psychological cohesion and social stigma).
Category
Behavior
2
Description
Control group: First, all questionnaires will be filled by this group. However, this group will not receive any counseling or psychotherapy, and eventually the questionnaires will be filled out again by this group after about (about a month).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare of Tabriz city
Full name of responsible person
Roya Torkashvand
Street address
No. 11 , second ten meters west , first twelve meters,, Zafaranieh town
City
tabriz
Province
East Azarbaijan
Postal code
5166755666
Phone
+98 41 3330 8219
Email
razavi73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Ziyayerad
Street address
School of Midwifery Nursing , University Blvd.Arghavanieh,,East Jay St.,Esfahan
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2113
Fax
Email
razavi73@yahoo.com
Web page address
https://www.khuisf.ac.ir
Grant name
------
Grant code / Reference number
----
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Mahtab Razavinezhad
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11 , second west, first ten meters, twelve meters, Saffron town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166755666
Phone
+98 41 3330 8219
Email
razavi73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Razavinezhad
Position
Master student of psychiatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 11 , second west, first ten meters, Saffron town, twelve meters,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51667-55666
Phone
+98 41 3330 8219
Email
razavi73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahtab Razavinezhad Ahari
Position
Master student of psychiatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
2nd floor , No. 11 , The second ten meters west , The first twelve meters , Zafaraniye . Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51667556666
Phone
+98 41 3330 6131
Email
razavi73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available