<?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>IRCT2013053013523N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-26</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Impacts of Liaison Nurse Services on ICU Discharged Patients' Physical and Psychological Status</public_title>
      <acronym></acronym>
      <scientific_title>The Impacts of Liaison Nurse Services on ICU Discharged Patients' Physical and Psychological Status  in Rajaee Hospital – Shiraz - 2013</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>208</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13360</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>circulatory and respiratory status.</hc_freetext>
      <i_freetext>Intervention 1: In this study, the patients in the intervention group are visited by the ICU liaison nurse at least once a day, the necessary interventions will be performed, and their physical as well as mental status will be recorded. Based on the studies conducted on the issue, an ICU liaison nurse acts in 4 fields as follows:&#13;
1. Training the ward nurses regarding the patients’ care requirements and supporting them. In this regard, The nurse will be informed about the process of patient care in ICU&#13;
The patient’s body systems, such as the respiratory, cardiovascular, nervous, and gastrointestinal systems, will be reviewed by the responsible nurse, the nurse will be trained regarding the patient’s needs in the ward, and the essential points will be put in the patient’s kardex in form of a pamphlet.&#13;
The medicines that will be given to the patient in the ward will be reviewed with the responsible nurse.&#13;
The liaison nurse’s phone number will be given to the ward nurses to contact her/him if necessary.&#13;
2. Creating relationship between the ward and ICU and preparing the two units for the transfer process:&#13;
Informing the ICU nurses about the ward facilities&#13;
Encouraging the ICU nurses to give complete and clear reports about the patients to the responsible nurses of the ward&#13;
Preparing appropriate room, bed, and facilities in the ward for the patients discharged from ICU before and after they are transferred to the ward&#13;
Trying to inform the ward personnel regarding the patients’ transfer and status at least 2-3 hours before the transfer. Also, attempts should be made to avoid patient transfer at inconvenient hours. &#13;
3. Training and physically and psychologically supporting the patients:&#13;
Obtaining the patients’ reports of psychical and mental status during ICU stay and reviewing their records at the beginning of the intervention&#13;
Explaining the reason for transfer, the facilities, and the number of ward personnel to the patients&#13;
Physically and emotionally supporting the patients since they are informed about being discharged&#13;
ICU liaison nurse visiting the patients every day, assessing their physical and mental status, and providing them with the necessary care&#13;
Training the patients to care about themselves both physically and mentally&#13;
4. Training and supporting the patients’ families:&#13;
Providing the patient’s family with the information about his/her transfer to the ward as well as the ward facilities&#13;
Explaining the patient’s present status and improvement process to his/her family&#13;
Training the families regarding supporting the patients in the ward to decrease both the patients’ and the families’ stress. Intervention 2: On the other hand, the control group patients are transferred to the ward with no interventions. Then, their physical and mental status will be investigated and recorded at the time of transfer and 24 and 72 hours after being transferred to the ward.</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>Dr. Marzieh Momennasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Nursing and Midwifery College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 1727 7445</telephone>
        <email>momennasab@sums.ac.ir - mnasab48@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Marzieh Momennasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fatemeh Nursing and Midwifery College</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 1727 7445</telephone>
        <email>mnasab48@yahoo.com -  momennasab@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The inclusion criteria of the study: Age above 18 years;  willingness to take part in the study; Ability to communicate either verbally or non-verbally; The first admission in ICU; Having been in ICU for at least 72 hours; Not having the history of critical physical diseases and known psychological disorders before being hospitalized in ICU.&#13;
The exclusion criteria of the study: Unwillingness to cooperate or disruption of the patient’s cooperation for any reason; Being transferred to another hospital; Being transferred to the ward on Friday or between 8 P.M. and 8 A.M.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R00-R09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Symptoms and signs involving the circulatory and respiratory systems</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the patients in the intervention group are visited by the ICU liaison nurse at least once a day, the necessary interventions will be performed, and their physical as well as mental status will be recorded. Based on the studies conducted on the issue, an ICU liaison nurse acts in 4 fields as follows:&#13;
1. Training the ward nurses regarding the patients’ care requirements and supporting them. In this regard, The nurse will be informed about the process of patient care in ICU&#13;
The patient’s body systems, such as the respiratory, cardiovascular, nervous, and gastrointestinal systems, will be reviewed by the responsible nurse, the nurse will be trained regarding the patient’s needs in the ward, and the essential points will be put in the patient’s kardex in form of a pamphlet.&#13;
The medicines that will be given to the patient in the ward will be reviewed with the responsible nurse.&#13;
The liaison nurse’s phone number will be given to the ward nurses to contact her/him if necessary.&#13;
2. Creating relationship between the ward and ICU and preparing the two units for the transfer process:&#13;
Informing the ICU nurses about the ward facilities&#13;
Encouraging the ICU nurses to give complete and clear reports about the patients to the responsible nurses of the ward&#13;
Preparing appropriate room, bed, and facilities in the ward for the patients discharged from ICU before and after they are transferred to the ward&#13;
Trying to inform the ward personnel regarding the patients’ transfer and status at least 2-3 hours before the transfer. Also, attempts should be made to avoid patient transfer at inconvenient hours. &#13;
3. Training and physically and psychologically supporting the patients:&#13;
Obtaining the patients’ reports of psychical and mental status during ICU stay and reviewing their records at the beginning of the intervention&#13;
Explaining the reason for transfer, the facilities, and the number of ward personnel to the patients&#13;
Physically and emotionally supporting the patients since they are informed about being discharged&#13;
ICU liaison nurse visiting the patients every day, assessing their physical and mental status, and providing them with the necessary care&#13;
Training the patients to care about themselves both physically and mentally&#13;
4. Training and supporting the patients’ families:&#13;
Providing the patient’s family with the information about his/her transfer to the ward as well as the ward facilities&#13;
Explaining the patient’s present status and improvement process to his/her family&#13;
Training the families regarding supporting the patients in the ward to decrease both the patients’ and the families’ stress</i_keyword>
      <i_keyword>On the other hand, the control group patients are transferred to the ward with no interventions. Then, their physical and mental status will be investigated and recorded at the time of transfer and 24 and 72 hours after being transferred to the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Physical status. Timepoint: Time of transfer and 24 and 72 hours after being transferred to the ward. Method of measurement: According to MEWS(Modified early warning score)- Measurment of vital sign- Document return ( readmission ) to icu - Document death and etc .</prim_outcome>
      <prim_outcome>Psychological status. Timepoint: Time of transfer and 24 and 72 hours after being transferred to the ward. Method of measurement: Hospital Anxiety and Depression Scale ( HADS ).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Return ( readmission ) to icu. Timepoint: 24 and 72 hours after being transferred to the ward. Method of measurement: Return ( readmission ) to icu and not return.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-04-21</approval_date>
        <contact_name>Shiraz Univesity of Medical Sciences</contact_name>
        <contact_address>Shiraz Univesity of Medical Sciences, Zand st, Shiraz Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
