<?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>IRCT201103256103N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-10-22</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>The effectiveness of Implementing Nursing Consultation on" "Anxiety and Satisfaction of Patients Undergoing GI Endoscopy</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Implementing Nursing Consultation on" "Anxiety and Satisfaction of Patients Undergoing GI Endoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6548</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Uper GI Endoscopy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: consultation for half an hour one day before Endoscopy. This consultatoin is performed by researcher for out-patients in hospital or patient home(at tendency of patient) and for inpatients on the bed of patient . This consoltation is nursing cosultation and do not need to advanced techniques of psicologia. This consoltation is including instruction about needing preparation pre Endoscopy (such as diet, drugs,...), explanation about stages pre(instruction necessary preparations), in(explanation about What will happen during Endoscopy)) and after(explanation about the probable problems that will meet after Endoscopy ) Endoscopy. It increase patient knowledge about Endoscopy and its advantages and probable risks and allow to patient that express his sensations and questions and answering the questions of patient. Intervention 2: Control group: No intervention other than routine care.</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>Olia Bakhshayeshi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Next to Allameh Tabatabai library,  End of Jomhoori Street, Mahallat</address>
        <city>Mahallat</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3781684916</zip>
        <telephone>+98 32 51255</telephone>
        <email>roya_b1383</email>
        <affiliation>Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aliraza Nikbakht Nasrabadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery,  Prime of eastward Nosrat,Tohid Square, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6459</zip>
        <telephone>+98 21 6692 2700</telephone>
        <email>nikbakht@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Having order of upper GI Endoscopy at least one day before the procedure, Age between 18 and 80 years old, Ability to speak and understanding Persian language, no problem to see the VAS, no previous endoscopy, no order of emergency Endoscopy, no History of psychological disease or anxiety disorder, no consumption of opiate or sedative drugs, no severe pain due to nature of disease, no addiction to opium or narcotics, no hypertension or using anti hypertensive drugs&#13;
Exclusion criteria: canceling the Endoscopy due to any reason except for patient’s anxiety, no willingness to participate in the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K20, K31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diseases of Oesophagus, Stomach and Duodenum</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: consultation for half an hour one day before Endoscopy. This consultatoin is performed by researcher for out-patients in hospital or patient home(at tendency of patient) and for inpatients on the bed of patient . This consoltation is nursing cosultation and do not need to advanced techniques of psicologia. This consoltation is including instruction about needing preparation pre Endoscopy (such as diet, drugs,...), explanation about stages pre(instruction necessary preparations), in(explanation about What will happen during Endoscopy)) and after(explanation about the probable problems that will meet after Endoscopy ) Endoscopy. It increase patient knowledge about Endoscopy and its advantages and probable risks and allow to patient that express his sensations and questions and answering the questions of patient.</i_keyword>
      <i_keyword>Control group: No intervention other than routine care</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood presure. Timepoint: One day before Endoscopy(before consultation) and immediately before Endoscopy. Method of measurement: indicator.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: One day before Endoscopy(before consultation) and immediately before Endoscopy. Method of measurement: spielberger questionair.</prim_outcome>
      <prim_outcome>Cooperation. Timepoint: WHILE Endoscopy. Method of measurement: Visual Analog scale.</prim_outcome>
      <prim_outcome>Pulse rate. Timepoint: One day before Endoscopy(before consultation) and immediately before Endoscopy. Method of measurement: by researcher.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: One day before Endoscopy (before consultation) and immediately before Endoscopy. Method of measurement: by researcher.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Patient's satisfaction. Timepoint: 6 hours after Endoscopy. Method of measurement: Visual Analog Scale.</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>Tehran University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-10</approval_date>
        <contact_name>Tehran University of Medical Sciences</contact_name>
        <contact_address>Central building of TUMS, Ghods street, Keshavarz Blvd., Tehran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
