<?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>IRCT201404278589N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-11-04</date_registration>
      <primary_sponsor>Vice chancellor for research Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of communicating with patient before anesthesia on pain and agitation</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial comparing the effects of patient communication before general anesthesia on post-operation pain and agitation of patients after endoscopic sinus surgery in the recovery room</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-05-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>61</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/9097</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>acute pain and agitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention1: The patients of case group were involved in a 15-20 minutes of informative and supportive communication once in the night before the surgery and once again for 5-10 minutes just before the surgery. All of the informative and supportive plans were designed by psychologists and anesthesiologist. Supportive communication plan include; the researcher introduces his/her self and asks the patients about their name, job, education, experience of their previous surgery. The researcher encourages the patients to express their feeling and anxiety about their surgery. Also assures the patients about their complete coverage during surgery. And says that there is not any facial incision in your face in this surgery. We have not had any mortality in this kind of surgery  in this hospital. Informative communication plan; the Patients are informed about general anesthesia and its equipment such as mask, anesthesia machine, ambo bag, monitoring, common side-effects that may occur during anesthesia, post-op pain, nausea, vomiting and how to control them. Also they are informed about how improve their breathing with closed nasal way and when they can eat and drink after surgery. They are informed about intra nasal pack (two days after surgery is removed) and some others routine actions (washing their nose with normal saline). Intervention 2: Intervention2: The patients of control group did not receive any informative and supportive communication and were only treated with routine OR procedures. If they had some questions, the stuffs answered to patient’s questions.</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>Fatemeh Navidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralam hospital, Saadi St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1637818561</zip>
        <telephone>+98 21 6670 6107</telephone>
        <email>saharnavidi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Navidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Amiralam hospital, Saadi St., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1637818561</zip>
        <telephone>+98 21 6670 6107</telephone>
        <email>saharnavidi@yahoo.com</email>
        <affiliation>Amiralam hospital, Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : patients, who were all over 18 years old  and they were all non-smokers with no drug addiction or long-term (&gt;6 months) use of analgesic and/or NSAIDs, Patients were diagnosed and scheduled for limited sinus endoscopy surgery (opening maxillary, ethmoid and sphenoid sinus with or without partial resection of middle cornea without septoplasty including polyposis and sinusitis) entered the study consecutively. &#13;
Exclusion criteria: Patients who faced complications during anesthesia (cardiac arrest, bradycardia (HR&lt;40) and bronchospasm), needed a more advanced sinus endoscopic surgery, in whom cautery was used for hemostasis or surgery, duration of longer than 4 hours were excluded  from the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>61 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.9, R45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized pain NOS, Worries NOS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention1: The patients of case group were involved in a 15-20 minutes of informative and supportive communication once in the night before the surgery and once again for 5-10 minutes just before the surgery. All of the informative and supportive plans were designed by psychologists and anesthesiologist. Supportive communication plan include; the researcher introduces his/her self and asks the patients about their name, job, education, experience of their previous surgery. The researcher encourages the patients to express their feeling and anxiety about their surgery. Also assures the patients about their complete coverage during surgery. And says that there is not any facial incision in your face in this surgery. We have not had any mortality in this kind of surgery  in this hospital. Informative communication plan; the Patients are informed about general anesthesia and its equipment such as mask, anesthesia machine, ambo bag, monitoring, common side-effects that may occur during anesthesia, post-op pain, nausea, vomiting and how to control them. Also they are informed about how improve their breathing with closed nasal way and when they can eat and drink after surgery. They are informed about intra nasal pack (two days after surgery is removed) and some others routine actions (washing their nose with normal saline).</i_keyword>
      <i_keyword>Intervention2: The patients of control group did not receive any informative and supportive communication and were only treated with routine OR procedures. If they had some questions, the stuffs answered to patient’s questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Entering the recovery, During the recovery entrance, Leaving the recovery. Method of measurement: Visual Analog Scale, Non-verbal Analog Scale.</prim_outcome>
      <prim_outcome>Agitation. Timepoint: Entering the recovery, During the recovery entrance, Leaving the recovery. Method of measurement: Riker Sedation-Agitation Scale.</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>2011-07-09</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Sciences, Vakilabad St., Mashhad Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
