<?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>IRCT2015112925288N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-13</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of intentionality presence of Cardiac Artery Surgery</public_title>
      <acronym></acronym>
      <scientific_title>The effect of holistic nurse's intentional presence on the depression, stress and anxiety of the patients undergoing coronary artery bypass graft</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21178</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>Coronary artery disease.</hc_freetext>
      <i_freetext>Intervention 1: In control group: In the beginning of patients’ admission to open heart surgery ward, subjects’ consent was obtained and their demographic information was obtained by a questionnaire examined their anxiety, stress, and depression and routine measures were taken for patients. In addition, educational pamphlets available in the ward along with educational pamphlets related to relation were provided for patents.&#13;
&#13;
During patient discharge, questionnaire assessing the anxiety, stress, and depression DASS 21 was completed again. In the control group, relaxation techniques and training to patients were performed trough educational pamphlets (Appendix 10) without the presence of a nurse (researcher), but measuring vital signs were measured and recorded during the four stages similar to  experimental group. Intervention 2: Experimental group: intervention begins from patient hospitalization time in the open-heart surgery time. After introducing himself to patients, completing the demographic form and conscious consent of patient, and completing assessing the anxiety, stress and depression of patient by DASSS 21, researcher implemented the presence process at three levels of 1. Physical presence, 2. Mental presence and 3. Therapeutic presence.&#13;
Accordingly, nurse will be able to select and use the best method for patients among the holistic methods based on unique investigation of each patient and determining the stressful resources, using strategies such as using and training relation or training the patient on unknowns, by relying on his specialized skill and knowledge, his nursing diagnoses (Table 3-1), and based on patient priority.&#13;
Specifically, presence of nurse depends on individual characteristics of nurse, individual characteristics of client, characteristics shared in the communicative space of nurse-client, an appropriate environment to do communicative task, and performance decisions of nurse. The first session of intended presence in the open-heart surgery ward and before surgery was implemented. The second session was implemented after patient recovery in the intensive care unit and third and fourth sessions were implemented in the heart surgery ward. During nurse-client interaction, there are points the probable dose of presence. Specifically, relying on his clinical skill and his previous experiences in the presence process, nurse interprets the latent delicate signs and objective needs of the patient, and he deliberates and makes decision in the special moment on the most appropriate presence dose by considering environmental factors. On average, presence dose is determined based on patient’s need in each shift and 30 to 45 minutes has been considered (Figure 3-10. If patient needed, number of therapeutic sessions and presence dose might increase.  After therapeutic sessions of presence, on the patient discharge, patient complemented the questionnaire assessing the anxiety, stress, and depression DASS 21 again.</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>Nahid Aghedati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Ibn-e-Sina st.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Aghebatin1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid aghebati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>West Ibn-e-Sina, School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9187113648</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>Aghebatin1@mums.ac.ir; Khajianz1@mums.ac.ir</email>
        <affiliation>Mahhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria of study &#13;
1. Willingness to participate in the study&#13;
2. Age between 38 and 75 years&#13;
3.  Having at least the literacy of writing and reading &#13;
4. Having an elective surgery&#13;
5. The ability to communicate with researcher&#13;
6. Lack of psychological disorders&#13;
7. Non- use of antipsychotic drugs&#13;
8. Candidate for coronary artery bypasses graft (CABG)&#13;
9. Lack of drug addiction&#13;
Exclusion criteria of study:&#13;
1. Refusing from continued participation in the study and collaboration with researcher&#13;
2. Incidence of physical disorders during the study (drainage that requires for operating room again)&#13;
3. Death of subject of study &#13;
4. Postoperative cognitive dysfunction (delirium, lack of knowledge of time, place, and person)&#13;
5. Late recovery and prolonged hospitalization (recovery after 6 hours or hospitalization more than 2 days in intensive care unit)&#13;
6. Heart surgery for the second time&#13;
7. Postoperative drug addiction</inclusion_criteria>
      <agemin>38 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>125.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Atherosclerotic heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In control group: In the beginning of patients’ admission to open heart surgery ward, subjects’ consent was obtained and their demographic information was obtained by a questionnaire examined their anxiety, stress, and depression and routine measures were taken for patients. In addition, educational pamphlets available in the ward along with educational pamphlets related to relation were provided for patents.&#13;
&#13;
During patient discharge, questionnaire assessing the anxiety, stress, and depression DASS 21 was completed again. In the control group, relaxation techniques and training to patients were performed trough educational pamphlets (Appendix 10) without the presence of a nurse (researcher), but measuring vital signs were measured and recorded during the four stages similar to  experimental group.</i_keyword>
      <i_keyword>Experimental group: intervention begins from patient hospitalization time in the open-heart surgery time. After introducing himself to patients, completing the demographic form and conscious consent of patient, and completing assessing the anxiety, stress and depression of patient by DASSS 21, researcher implemented the presence process at three levels of 1. Physical presence, 2. Mental presence and 3. Therapeutic presence.&#13;
Accordingly, nurse will be able to select and use the best method for patients among the holistic methods based on unique investigation of each patient and determining the stressful resources, using strategies such as using and training relation or training the patient on unknowns, by relying on his specialized skill and knowledge, his nursing diagnoses (Table 3-1), and based on patient priority.&#13;
Specifically, presence of nurse depends on individual characteristics of nurse, individual characteristics of client, characteristics shared in the communicative space of nurse-client, an appropriate environment to do communicative task, and performance decisions of nurse. The first session of intended presence in the open-heart surgery ward and before surgery was implemented. The second session was implemented after patient recovery in the intensive care unit and third and fourth sessions were implemented in the heart surgery ward. During nurse-client interaction, there are points the probable dose of presence. Specifically, relying on his clinical skill and his previous experiences in the presence process, nurse interprets the latent delicate signs and objective needs of the patient, and he deliberates and makes decision in the special moment on the most appropriate presence dose by considering environmental factors. On average, presence dose is determined based on patient’s need in each shift and 30 to 45 minutes has been considered (Figure 3-10. If patient needed, number of therapeutic sessions and presence dose might increase.  After therapeutic sessions of presence, on the patient discharge, patient complemented the questionnaire assessing the anxiety, stress, and depression DASS 21 again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and then after intervention. Method of measurement: Dass21 scal and stressors.</prim_outcome>
      <prim_outcome>Stress. Timepoint: Before and then after intervention. Method of measurement: Dass21 scal and stressors.</prim_outcome>
      <prim_outcome>Depresion. Timepoint: Before and then after intervention. Method of measurement: Dass21 scal and stressors.</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, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-04-17</approval_date>
        <contact_name>Mashhad University of Medical Sciences</contact_name>
        <contact_address>Four ways PhD, School of Nursing and Midwifery, Mashhad Jarjani Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
