<?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>IRCT20190917044798N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-20</date_registration>
      <primary_sponsor>Ardakan University</primary_sponsor>
      <public_title>The Effectiveness of Self-Transcendence Based Intervention</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Self-Transcendence Based Intervention on Self-Coherence and Loneliness of Individuals with Spinal Cord Injury: A Clinical Randomized Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-27</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Parallel groups were chosen because the participants of control group received a placebo intervention, Randomization description: Among individuals with spinal cord injury referring to rehabilitation centers of Abadeh City (Iran), a total of 44 male patients were selected by purposeful sampling; Then they were randomly assigned to control and experimental groups. Simple randomization by a table of random numbers was used to  assigned the participants in the experimental and control groups; In order to use the table of random numbers, it was first decided to read the numbers from the top of the table. The numbers 01-22 were selected for the experimental group and the numbers 23-44 were selected for the control group. Allocation concealment was also used to ensure that the randomization sequence was performed without knowing which patient received which treatment. In the implementation of the randomization process, the researcher who was involved in creating the randomization plan was different from the researcher who was involved in enrolling the participants. We tried to eliminate the bias that can be created by the awareness of the researcher who creating the random sequence, Blinding description: Because the participants in the control group also participated in several sessions about psychological consequences of spinal cord injury as a placebo, none of the participants in the experimental and control groups were aware of how the study groups were assigned.</study_design>
      <phase>N/A</phase>
      <hc_freetext>آسیب نخاعی.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants of experimental group received 8 sessions of self-transcendence based intervention. The duration of each session was approximately 90 minutes. Intervention protocol was based on Frankl's existential theory and reed's self-transcendence theory. According to self-transcendence theories, a self-transcendent person seeks to understand the nature of the world, herself or himself values and meaning of life; he/she looks at life and relates with humans and the world in a transcendent manner. Therefore, in intervention sessions, concepts such as self-awareness, self-worth and spirituality were discussed; how to interact with others, hope in life, acceptance of problems, life events and death with a self-transcendence manner were taught. The sessions were conducted by one of the authors who had previously received necessary training in self-transcendence approach. Intervention 2: Control group: The control group was on the waiting list but received three placebo sessions including general descriptions of the characteristics of spinal cord injury.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The output of statistical software can be shared after identifying individuals

When:
Access period starts 6 months after the results are published

To whom:
Researchers of academic institutions

Conditions:
The data tare available from the corresponding author upon reasonable request

Where to obtain:
Corresponding Author (Yasser Rezapour-Mirsaleh)

How to obtain:
Send email to  correspondence author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yasser Rezapour-Mirsaleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Khatami Blv.</address>
        <city>Ardakan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951895491</zip>
        <telephone>+98 35 3390 6060</telephone>
        <email>y.rezapour@ardakan.ac.ir</email>
        <affiliation>Ardakan university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yasser Rezapour-Mirsaleh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Khatami Blv.</address>
        <city>Ardakan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8951895491</zip>
        <telephone>+98 35 3390 6060</telephone>
        <email>y.rezapour@ardakan.ac.ir</email>
        <affiliation>Ardakan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclination to participate in the study
has at least school education
age between 40-50 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a specific mental disorders
Receiving other psychological treatments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>S14.10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified injury of cervical spinal cord</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants of experimental group received 8 sessions of self-transcendence based intervention. The duration of each session was approximately 90 minutes. Intervention protocol was based on Frankl's existential theory and reed's self-transcendence theory. According to self-transcendence theories, a self-transcendent person seeks to understand the nature of the world, herself or himself values and meaning of life; he/she looks at life and relates with humans and the world in a transcendent manner. Therefore, in intervention sessions, concepts such as self-awareness, self-worth and spirituality were discussed; how to interact with others, hope in life, acceptance of problems, life events and death with a self-transcendence manner were taught. The sessions were conducted by one of the authors who had previously received necessary training in self-transcendence approach.</i_keyword>
      <i_keyword>Control group: The control group was on the waiting list but received three placebo sessions including general descriptions of the characteristics of spinal cord injury</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of loneliness feeling score. Timepoint: All participants answered to the UCLA loneliness scale as dependent variable at 3 time points (pre, post and 2-month follow-up test). Method of measurement: Loneliness was measured using a standardized questionnaire entitled "the UCLA Loneliness Scale", the validity and reliability of its Persian version  has been confirmed in an Iranian sample.</prim_outcome>
      <prim_outcome>Level of self-cohesion score. Timepoint: All participants responded to the Sense of Self Coherence (SOS) scale to measure self-cohesion as the dependent variable at 3 time points (pre-test, post-test, and 2-month follow-up test). Method of measurement: Self-cohesion was measured using a standardized questionnaire entitled "Sense of Self Coherence (SOS) scale" which has been provided by Antonovsky (1987); the validity and reliability of the its Persian version has been confirmed in an Iranian sample.</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>Ardakan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-27</approval_date>
        <contact_name>دانشگاه آزاد یزد</contact_name>
        <contact_address>Shohadaye Gomnam Blv Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
