<?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>IRCT20170308032961N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-22</date_registration>
      <primary_sponsor>Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</primary_sponsor>
      <public_title>Effect of psychological preparation on the anxiety level before colonoscopy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of psychological preparation on the anxiety level before colonoscopy in outpatients referred to Golestan hospital of Ahvaz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25558</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Randomization was based on the method of 4-way permuted blocks, Blinding description: The nurses were not informed that every patient has taken which consultation.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Psychological preparation was performed by a psychiatric resident in a separate room 2 to 3 hours before colonoscopy; after evaluating the concerns, the amount of information and the beliefs of the patients of colonoscopy in three domains: information, cognitive and behavioral the interventions were done as follows: Control Information: At this stage the patient inaccurate information is corrected and enough .1 explanation of additional information about how to perform a colonoscopy, time, duration and .general conditions of the process was given to the patient 2. Cognitive control: According to cognitive distortions found in patients, cognitive control was done for the patient (e.g., patient attention to the benefits of surgery and its positive tips instead focus on its unpleasant and negative aspects). 3. Behavioral control: the patient was given the behavioral control methods, including special breathing exercises, distraction techniques and an explanation on how the patient's knowledge-based colonoscopy to use these methods in the event of the occurrence of anxiety while doing a colonoscopy. Intervention 2: Control group: In the control group, 0 to 3 hours before the colonoscopy, the intervention will be done and more neutral content (properties of fruits and vegetables) that was prepared in the pamphlet, will be given to control groups, and no other intervention will be done.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadis Mehregan Nasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6455134358</zip>
        <telephone>+98 61 3631 2445</telephone>
        <email>ali.khossravi70@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hadis Mehregan Nasab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6455134358</zip>
        <telephone>+98 61 3631 2445</telephone>
        <email>ali.khossravi70@yahoo.com</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-80 years old
Farsi language conversation skills
Ability to communicate verbally
Lack of previous experience in colonoscopy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Dementia
Mental retardation
Obvious physical problems that interfere with the consultation
A history of major psychiatric disorders
Decline to participation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Psychological preparation was performed by a psychiatric resident in a separate room 2 to 3 hours before colonoscopy; after evaluating the concerns, the amount of information and the beliefs of the patients of colonoscopy in three domains: information, cognitive and behavioral the interventions were done as follows: Control Information: At this stage the patient inaccurate information is corrected and enough .1 explanation of additional information about how to perform a colonoscopy, time, duration and .general conditions of the process was given to the patient 2. Cognitive control: According to cognitive distortions found in patients, cognitive control was done for the patient (e.g., patient attention to the benefits of surgery and its positive tips instead focus on its unpleasant and negative aspects). 3. Behavioral control: the patient was given the behavioral control methods, including special breathing exercises, distraction techniques and an explanation on how the patient's knowledge-based colonoscopy to use these methods in the event of the occurrence of anxiety while doing a colonoscopy.</i_keyword>
      <i_keyword>Control group: In the control group, 0 to 3 hours before the colonoscopy, the intervention will be done and more neutral content (properties of fruits and vegetables) that was prepared in the pamphlet, will be given to control groups, and no other intervention will be done</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: 3-5 days before colonoscopy, After psychological preparation. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI) questionnaire.</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, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-10-17</approval_date>
        <contact_name>Ethics committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan BLV Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
