<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220619055214N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-06-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of biography on psychological integration and social stigma of Patients with paralysis of the spinal cord</public_title>
      <acronym></acronym>
      <scientific_title>The effect of group narrative therapy on sense of coherence and social stigma associated with traumatic spinal cord injury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Patients with traumatic spinal cord injury (Paraplegia). Condition 2: Patients with traumatic spinal cord injury( Quadriplegia).</hc_freetext>
      <i_freetext>Intervention 1: 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). Intervention 2: 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).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Confidentiality in protecting the personal information of each person -
There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahtab Razavinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11 , second west, first ten meters, twelve meters, Saffron town, Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166755666</zip>
        <telephone>+98 41 3330 8219</telephone>
        <email>razavi73@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahtab Razavinezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11 , second west,  first ten meters, Saffron town, twelve meters,Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>51667-55666</zip>
        <telephone>+98 41 3330 8219</telephone>
        <email>razavi73@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Be literate
Age 18 years and older</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No serious illness other than spinal cord injury
No mental illness
Lack of individual and group counseling and psychotherapy sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G82.2</hc_code>
      <hc_code>G82.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Paraplegia</hc_keyword>
      <hc_keyword>Quadriplegia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>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).</i_keyword>
      <i_keyword>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).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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.</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-01</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Isfahan (Khorasgan)</contact_name>
        <contact_address>University Blvd, Arghavanieh ,  East Jay St , Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
