<?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>IRCT20180729040630N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-18</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of training on Anxiety, stress, pain</public_title>
      <acronym></acronym>
      <scientific_title>Effect of training on Anxiety, stress, pain management and some postoperative complications in abdominal surgery patients referring to Ali ibn Abitaleb Hospital in Rafsanjan in 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>200</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36641</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block
Patients will be divided into 4 blocks and in randomized layers with a level of education. Levels of classification based on the level of education in three levels (Illiterate, less than diploma and more than diploma).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Abdominal pain. Condition 2: anxiety. Condition 3: Stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Training by a doctor (Training by physician  Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain). Intervention 2: Intervention group: Training by a nurse (Training by nurse Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain). Intervention 3: Intervention group: Training with pamphlets (Training Patients will be given a pamphlet within 48 hours before the surgery. Trainings include providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain). Intervention 4: Control group: No training (In the control group the training will not be given).</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Ali Zakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali-ibn abitaleb hospital , Rafsanjan, Iran</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34342316</telephone>
        <email>mazakeri@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Ali Zakeri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ali-ibn abitaleb hospital, Rafsanjan, Iran</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7717933777</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>mazakeri@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Criteria for entering the study:                                                       Age between 18 and 75 years                                                  Patient with criteria for performing elective surgery in the abdomen                                                                                            To be hospitalized for up to 46 hours after surgery.                Ability to understand and speak Persian                            Interested in participating in the study                                          The absence of mental illness recorded in the case                  Able to communicate and understand the questionnaire          Non-drug addiction and other narcotic drugs                                No history of chronic pain</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Exit criteria:                                                                     Unwillingness of patients to continue reading                          There is no problem as long as the patient is unable to continue studying                                                                                       Return to the operating room                                              Confusion during the postoperative period                       Admission to the Intensive Care Unit                                Participate in another clinical trial at the same time                   Any factor that causes the patient to get out of reach 48 hours (lack of cooperation, early clearance, and personal satisfaction).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R10</hc_code>
      <hc_code>F41</hc_code>
      <hc_code>Z73.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abdominal and pelvic pain</hc_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
      <hc_keyword>Stress, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Training by a doctor (Training by physician  Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).</i_keyword>
      <i_keyword>Intervention group: Training by a nurse (Training by nurse Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).</i_keyword>
      <i_keyword>Intervention group: Training with pamphlets (Training Patients will be given a pamphlet within 48 hours before the surgery. Trainings include providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).</i_keyword>
      <i_keyword>Control group: No training (In the control group the training will not be given).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain management. Timepoint: After the intervention. Method of measurement: Revised American Pain Society Patient Outcome Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and after intervention. Method of measurement: state-trait anxiety inventory.</prim_outcome>
      <prim_outcome>Emotional preoperative stress. Timepoint: Before intervention. Method of measurement: brief measure of emotional preoperative stress.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postoperative complications. Timepoint: after intervention. Method of measurement: Report the type of postoperative complications.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-21</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Imam Ali Blvd, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
