<?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>IRCT20230608058420N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison of two patterns of caregiving and behavior change on burden of care, resilience and self-efficacy of spouses of war veterans.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual self-care model and the developed parallel process model on the burden of care, resilience and self-efficacy of spouses of people with post-war stress vetera(PTSD)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70613</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done in a simple way using the website sealedenvelope.com. Randomization is done by forming blocks of size 6 as follows: ABCCBA - BCABCA - CABACB - BCAACB - CCBABA - BCACBA - BACBAC - BACCAB - BACCBA . Based on the randomization software, the subjects will be grouped in blocks of size six and will be placed in three groups A, B, and C.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: self efficacy. Condition 2: burden of care. Condition 3: resilience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Before conducting the research, the researcher will explain the purpose of the research to obtain informed consent regarding the safety and anonymity of the research units, and they will be told that they can withdraw from the research even during the study. Then, individual or group sessions will be held at the counseling center of the Shahid Foundation for 45-60 minutes based on the structures of the spiritual self-care model. The spiritual self-care session will consist of six individual training sessions. The content of the sessions will be prepared based on the educational needs of patients and the protocol of similar studies (Omidi, Kazemi and Khatiban, 2014) (Salimi, Garmarodi, Hosseini and Batabi, 2014). Then after the intervention, three questionnaires are completed. Intervention 2: Intervention group 2: Before conducting the research, while explaining the purpose of the research, the researcher assures the safety and anonymity of the research units. Then, individual or group sessions will be held at the counseling center of Shahid Foundation for 45-60 minutes based on the structures of the developed parallel process model. The parallel process model developed based on model instruments and similar articles will be conducted in six individual or group training sessions. These sessions will be held once a week (30 to 40 minutes) at the foundation or home. Then after the intervention, three The questionnaire is completed. Intervention 3: Control group: This group will receive care and routine consultations of the centers.</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:
Its release schedule is not yet known

When:
Its release schedule is not yet known

To whom:
Its release schedule is not yet known

Conditions:
Its release schedule is not yet known

Where to obtain:
Its release schedule is not yet known

How to obtain:
Its release schedule is not yet known

Comments:
6 articles will be extracted from this proposal.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akram Rezaei Aghuei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 475; Daneshmoz 28 Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178884146</zip>
        <telephone>+98 938 228 9230</telephone>
        <email>akramrezari1365@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Rezaei aghuei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 475; Daneshmoz 28 Street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9178884146</zip>
        <telephone>+98 938 228 9230</telephone>
        <email>akramrezari1365@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Spouses of people with post-traumatic stress disorder caused by the blast wave
living with their spouses at the moment
awareness of time and place</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>People who do not want to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Before conducting the research, the researcher will explain the purpose of the research to obtain informed consent regarding the safety and anonymity of the research units, and they will be told that they can withdraw from the research even during the study. Then, individual or group sessions will be held at the counseling center of the Shahid Foundation for 45-60 minutes based on the structures of the spiritual self-care model. The spiritual self-care session will consist of six individual training sessions. The content of the sessions will be prepared based on the educational needs of patients and the protocol of similar studies (Omidi, Kazemi and Khatiban, 2014) (Salimi, Garmarodi, Hosseini and Batabi, 2014). Then after the intervention, three questionnaires are completed.</i_keyword>
      <i_keyword>Intervention group 2: Before conducting the research, while explaining the purpose of the research, the researcher assures the safety and anonymity of the research units. Then, individual or group sessions will be held at the counseling center of Shahid Foundation for 45-60 minutes based on the structures of the developed parallel process model. The parallel process model developed based on model instruments and similar articles will be conducted in six individual or group training sessions. These sessions will be held once a week (30 to 40 minutes) at the foundation or home. Then after the intervention, three The questionnaire is completed</i_keyword>
      <i_keyword>Control group: This group will receive care and routine consultations of the centers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-efficacy score in Domkai questionnaire. Timepoint: Self-efficacy questionnaires will be completed first before the intervention and then after 6 training sessions (6 weeks). Method of measurement: Dumkai self-efficacy questionnaire.</prim_outcome>
      <prim_outcome>Burden of care. Timepoint: Burden of care questionnaires will be completed first before the start of the intervention and then again after 6 training sessions (6 weeks). Method of measurement: Standard burden of care questionnaire.</prim_outcome>
      <prim_outcome>Resilience. Timepoint: The resilience questionnaire will be completed first before the intervention and then again after 6 training sessions (6 weeks). Method of measurement: Connor and Davidson Resilience Questionnaire.</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>2023-05-03</approval_date>
        <contact_name>Ethics Committee in Research, Faculty of Medicine, Islamic Azad University - Mashhad Medical Science</contact_name>
        <contact_address>Central Organization of Islamic Azad University of Mashhad, East side, University campus, Ostad Yousefi intersection, Emamieh Blvd., Qasimabad (Gharb city), Mashhad, Khorasan Razavi, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
