<?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>IRCT2017072933998N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Qom University of Medical Sciences</primary_sponsor>
      <public_title>The effect of a liaison nurse service on stress of patients and anxiety and stress of patients’ families after intensive care unit transfer</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a liaison nurse service on stress of patients and anxiety and stress of patients’ families after intensive care unit transfer.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>248</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26118</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Anxiety. Condition 2: Stress.</hc_freetext>
      <i_freetext>Intervention 1: In the control group, patients will receive routine care. Intervention 2: Intervention group: Liaison nurse Services will start from the beginning of decision for patient transfer from intensive care unit to the general ward and will continue for patients and families up to 24 hours of hospitalization. The Liaison nurse activity will be as follows based on the studies:* Physical and emotional care and support and training of the patient and his family: Receiving a report on the patient's physical condition from nurses during hospitalization in ICU, Communicating with the patient and initial evaluating the patient's needs. Explaining to the patient and family about the cause of the patient transfer, facilities and personnel, Daily visits by a Liaison nurse with the patient and family, Explaining to the family about the patient's current condition and recovery process, Family Education how to support the patient in the ward to reduce the anxiety and stress of the family and the patient.**Communicating between the intensive care unit and the general ward. Liaison nurse will inform nurses from the facilities in the intensive care unit, encouraging the ICU nurses to give a full report of patients to the head nurse, Trying to inform the departmental staff about the patient's transfer and his condition at least two hours before the transfer of the patient and during the transfer to the general ward. All patients’ body systems including respiratory, cardiovascular, renal, nervous and digestive status will be reviewed by the patient's nurse. And what about all the needs of the patient and his family will be taught in the department.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kurosh Jodaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Allied, Qom University of Medical Sciences Pardis, Qom</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3320 9074</telephone>
        <email>kuroshjodaki@gmail.com</email>
        <affiliation>Qom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>kurosh jodaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Allied, Qom University of Medical Sciences Pardis, Qom.</address>
        <city>Qom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 25 3320 9074</telephone>
        <email>kuroshjodaki@gmail.com</email>
        <affiliation>Qom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: The patient should be admitted for at least 24 hours in ICU; being aware of time, place and person; The patient should be able to understand the contents in the Persian language; s/he should not have the history of proven mental diseases; s/he should not have severe visual and hearing disorders; s/he should have full consent for the study; no anti-anxiety medication consumption; the age group is over 18 years old. Exclusion criteria: Occurrence of unexpected events for the patient during the study (Patient dies); s/he should not have the desire to continue the clinical working trial.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
      <hc_code>F43.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</hc_keyword>
      <hc_keyword>Acute stress reaction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group, patients will receive routine care.</i_keyword>
      <i_keyword>Intervention group: Liaison nurse Services will start from the beginning of decision for patient transfer from intensive care unit to the general ward and will continue for patients and families up to 24 hours of hospitalization. The Liaison nurse activity will be as follows based on the studies:* Physical and emotional care and support and training of the patient and his family: Receiving a report on the patient's physical condition from nurses during hospitalization in ICU, Communicating with the patient and initial evaluating the patient's needs. Explaining to the patient and family about the cause of the patient transfer, facilities and personnel, Daily visits by a Liaison nurse with the patient and family, Explaining to the family about the patient's current condition and recovery process, Family Education how to support the patient in the ward to reduce the anxiety and stress of the family and the patient.**Communicating between the intensive care unit and the general ward. Liaison nurse will inform nurses from the facilities in the intensive care unit, encouraging the ICU nurses to give a full report of patients to the head nurse, Trying to inform the departmental staff about the patient's transfer and his condition at least two hours before the transfer of the patient and during the transfer to the general ward. All patients’ body systems including respiratory, cardiovascular, renal, nervous and digestive status will be reviewed by the patient's nurse. And what about all the needs of the patient and his family will be taught in the department.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before intervention, two hours after intervention and 24 hours after intervention. Method of measurement: Spielberger Anxiety questionnaire.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before intervention, two hours after intervention and 24 hours after intervention. Method of measurement: Stress Visual Scale(VAS).</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>Vice chancellor for research, Qom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-05</approval_date>
        <contact_name>Ethics Committee of Qom University of Medical Sciences</contact_name>
        <contact_address>Qom University of Medical Sciences, Saheli Street, Qom Qom  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
