<?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>IRCT20210131050189N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-01</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Use of mobile application on preparation and anxiety before colonoscopy</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using a mobile application on preparation and anxiety before colonoscopy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73478</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Before starting the research, 40 white color cards and 40 black cards will be prepared. All the cards will be placed in an envelope, then the cards will be taken out randomly and numbered from 1 to 80 in order of exit. Each card will then be placed in a sealed envelope and its number will be written on the envelope. As each patient enters the study, a special envelope from number 1 to 80 will be opened for him. If the card is white, the participant will be assigned to the intervention group, and if the card is black, the participant will be assigned to the control group, Blinding description: The training will be given by Researcher A and the results will be evaluated by Researcher B, who will be unaware of the allocation of groups. Also, the data analyst will not know the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Suspected neoplasm of colon who were candidates for colonoscopy. Condition 2: Suspected neoplasm of colon who were candidates for colonoscopy. Condition 3: Crohn's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: On the day of going to the clinic and making an appointment for colonoscopy, the mobile application is provided, and after installation, training was given and followed up with it. The program contains information related to the causes of colonoscopy, preparation for colonoscopy, evaluation of the patient's readiness, and evaluation of the patient's medications and underlying diseases. Intervention 2: Control group: On the day of going to the clinic, pamphlets were given to the participants regarding the use of laxatives for bowel preparation,.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
By email to the corresponding author

When:
َAfter the publication of the article

To whom:
Academic researchers

Conditions:
More research

Where to obtain:
By email to the corresponding author

How to obtain:
By email to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raziyeh Ghafouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Nursing &amp; Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2520</telephone>
        <email>raziehghafouri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Raziyeh ghafouri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SBMU School of Nursing &amp; Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996835119</zip>
        <telephone>+98 21 8820 2520</telephone>
        <email>raziehghafouri@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>be a colonoscopy candidate
Having a smart phone</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Inability to use a smartphone
Having a medical history of suffering from cognitive diseases and depression or taking neuroleptics</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C18</hc_code>
      <hc_code>K58</hc_code>
      <hc_code>K50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of colon</hc_keyword>
      <hc_keyword>Irritable bowel syndrome</hc_keyword>
      <hc_keyword>Crohn's disease [regional enteritis]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Early detection</i_code>
      <i_code>Early detection</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: On the day of going to the clinic and making an appointment for colonoscopy, the mobile application is provided, and after installation, training was given and followed up with it. The program contains information related to the causes of colonoscopy, preparation for colonoscopy, evaluation of the patient's readiness, and evaluation of the patient's medications and underlying diseases.</i_keyword>
      <i_keyword>Control group: On the day of going to the clinic, pamphlets were given to the participants regarding the use of laxatives for bowel preparation,</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bowl Preparation. Timepoint: an colonoscopy. Method of measurement: The Boston Bowel Preparation Scale (BBPS).</prim_outcome>
      <prim_outcome>Colonoscopy Anxiety. Timepoint: After Colonoscopy. Method of measurement: Colonoscopy anxiety tool.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-09</approval_date>
        <contact_name>Research Ethics Committees of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
