<?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>IRCT20171002036498N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-17</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of clinical orientation teaching on anxiety, pain and satisfaction of patients candidating for endoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of clinical orientation teaching on anxiety, pain and satisfaction of patients candidating for endoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling method will be available. Samples are randomly assigned to the control and intervention groups based on age and sex variables. In this method, the first samples (20%) are randomly entered into the study and placed in each group. For the following examples, the sum of the indicators in the two groups is considered and the sample is assigned to the group that has a lesser sum.</study_design>
      <phase>3</phase>
      <hc_freetext>Gastrointestinal patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group receives in addition to routine ward training, clinical familiarization intervention with endoscopic procedure.  Clinical familiarization is held in the form of a 30-40 minute tour .  In the morning before the end of the procedure, after obtaining informed consent, they are transferred to the endoscopy unit and get acquainted with the endoscopy unit, equipment, equipment, medicines and observe how a patient performs endoscopy, then about how to perform endoscopy procedure. Post-procedure clinical care is also described. The researcher also answers patients' questions during this time. After the endoscopy is performed, another patient is transferred to the endoscopy room. After receiving lidocaine spray and sedative injection, while lying on your left side, the doctor guides the endoscope tube through the mouth to the throat. After passing the endoscope tip through the throat, the researcher transfers the patient to the endoscopy room and the patient observes the endoscopy procedure closely. Observation includes the operation of equipment, monitors, methods of taking pictures of the gastrointestinal tract, sampling, etc. The patient returns to the waiting room before the endoscope is removed. Their questions will be answered during this period. It takes at least two hours for the patient to return to the endoscopy department for endoscopy, before the endoscopy the anxiety questionnaire is completed again. During this period, the patient has enough time to get answers to his questions based on the observations. Intervention 2: control group: Receive routine ward training, including nurse training.</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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Benafshe Ave., West Shariati Blvd.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7719717653</zip>
        <telephone>+98 34 3426 2818</telephone>
        <email>iccn87@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Akbari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, Benafshe Ave., West Shariati Blvd.</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7719717653</zip>
        <telephone>+98 34 3426 2818</telephone>
        <email>iccn87@gmail.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Prescribed endoscopy
No history of endoscopy
Non-emergency endoscopy
No cognitive problems
No physical disability
Do not be deaf
No visual impairment
No history of mental illness
Do not have severe pain due to other diseases (cancer, etc.)
Ability to speak Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Uncooperative patient to continue
The patient becomes ill or has a complication
Use more sedatives than usual</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K92.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastrointestinal hemorrhage, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group receives in addition to routine ward training, clinical familiarization intervention with endoscopic procedure.  Clinical familiarization is held in the form of a 30-40 minute tour .  In the morning before the end of the procedure, after obtaining informed consent, they are transferred to the endoscopy unit and get acquainted with the endoscopy unit, equipment, equipment, medicines and observe how a patient performs endoscopy, then about how to perform endoscopy procedure. Post-procedure clinical care is also described. The researcher also answers patients' questions during this time. After the endoscopy is performed, another patient is transferred to the endoscopy room. After receiving lidocaine spray and sedative injection, while lying on your left side, the doctor guides the endoscope tube through the mouth to the throat. After passing the endoscope tip through the throat, the researcher transfers the patient to the endoscopy room and the patient observes the endoscopy procedure closely. Observation includes the operation of equipment, monitors, methods of taking pictures of the gastrointestinal tract, sampling, etc. The patient returns to the waiting room before the endoscope is removed. Their questions will be answered during this period. It takes at least two hours for the patient to return to the endoscopy department for endoscopy, before the endoscopy the anxiety questionnaire is completed again. During this period, the patient has enough time to get answers to his questions based on the observations.</i_keyword>
      <i_keyword>control group: Receive routine ward training, including nurse training.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety:  The score that patients receive from the Spielberger situational questionnaire  This numerical score is higher than 43. Timepoint: Before and after the intervention. Method of measurement: Spielberger Anxiety Scale.</prim_outcome>
      <prim_outcome>Satisfaction:  The patient's feeling is about the performance of the treatment team, the condition of the disease and the diagnostic-therapeutic methods. Timepoint: Before and after the intervention. Method of measurement: Satisfaction Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Unpleasant sensation and emotional experience. Timepoint: After the intervention. Method of measurement: Visual analogue 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-17</approval_date>
        <contact_name>Ethics committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>N0.1, motahari Blvd. Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
