<?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>IRCT20180721040540N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-15</date_registration>
      <primary_sponsor>Khoram-Abad University of Medical Sciences</primary_sponsor>
      <public_title>The impact of family-centered interventions on family anxiety and depression and self-efficacy</public_title>
      <acronym></acronym>
      <scientific_title>The impact of family-centered interventions on family anxiety and depression and self-efficacy in patients with loss of consciousness in intensive care units</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37991</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of sampling was convenience sampling method. Eligible subjects with using the Random stratified blocks method located in the intervention or control groups. (Stratified in order to gender equality in the both groups). Considering the gender as stratified, in the inside this stratifies, subjects as blocks 4-6 will located in the intervention or control groups randomly, Blinding description: Subjects wouldn't inform of their situation in group of intervention or control to end of study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, Depression and Self- Efficacy of  low conscious of caregivers.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group; in the intervention group, educations conducted in the tree steps. First step: Theoretical education about necessity of caring of loss conscious patients, management of nutrition, caring of skin, change position, prevention of bedsore, suction of secretions and …, Second step: Caregivers will presence in the clinical of patients and educated by researcher as practical in three days a week. Also educational brochure and pamphlet about the methods of caring of patients will be provided for caregivers.Three step: Caregivers will presence in the clinical of patients in corporation of researcher (nurse) and give caring to patients as practical. Intervention 2: Control group: the control group will be received usual care of the hospital by the end of the study. Of course, after the study the subjects in the control group will also benefit from the training provided for the intervention group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Because of security</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Heshmatolah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilomer 5 Khorramabad- Broujerd Road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>+98 66 3312 0174</telephone>
        <email>Heidari.H@Lums.ac.Ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Heshmatolah Heydari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometr 5 Kho- Broujer Road</address>
        <city>Khorramabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>68149-93165</zip>
        <telephone>+98 66 3312 0174</telephone>
        <email>Hiedari.H@Lums.ac.ir</email>
        <affiliation>Khoram-Abad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Caregivers with patients with loss of consciousness in intensive care units.
Willingness to participate in the study
Literate for reading and writing
Caregivers that among family members accept responsibility of caring of their patients directly.
Prediction of hospitalization of patient in the intensive care unit for at least two weeks</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Caregivers who  have an academic education in the field of health (physician, nurse or ...).
Caregivers who have the previous experience of caring for patients with loss of consciousness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group; in the intervention group, educations conducted in the tree steps. First step: Theoretical education about necessity of caring of loss conscious patients, management of nutrition, caring of skin, change position, prevention of bedsore, suction of secretions and …, Second step: Caregivers will presence in the clinical of patients and educated by researcher as practical in three days a week. Also educational brochure and pamphlet about the methods of caring of patients will be provided for caregivers.Three step: Caregivers will presence in the clinical of patients in corporation of researcher (nurse) and give caring to patients as practical.</i_keyword>
      <i_keyword>Control group: the control group will be received usual care of the hospital by the end of the study. Of course, after the study the subjects in the control group will also benefit from the training provided for the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety, Depression and Self- Efficacy. Timepoint: Before and 2 week after study. Method of measurement: Questionnaire of Hospital Anxiety and Depression Scale, &amp; Researcher-made  questionnaire  of Self-efficacy.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>. Timepoint: . Method of measurement: .</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>Khoram-Abad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-28</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>Kelometr 5 Kamalvand Khoramabad- Boroujerd Road, Lorestan University Of Medical Sciences Korramabad Lorestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
