<?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>IRCT20170928036465N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-27</date_registration>
      <primary_sponsor>Shiraz university of medical sciences</primary_sponsor>
      <public_title>The effect of psycho-educational intervention on anxiety, embarrassment and concern of judgment in female patients referring to general male surgeon</public_title>
      <acronym>does not have</acronym>
      <scientific_title>The effect of psycho-educational intervention on anxiety, embarrassment and concern in female patients referred to general male surgeon for colorectal examinations</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27250</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention, Randomization description: Sample selection: the method of selecting admission days of this surgeon for the intervention and control group will be randomly and by using random number table in block method. Visitation days for the mentioned surgeon will be done by randomized block design, and weekdays will be allocated to two groups through block method. First, the researcher constitutes different permutations of A (indicating the visitation date of intervention group) and B (indicating the visitation date of control group) which consist of 6 different modes: for example (1-AABB, 2-ABAB… 6-ABAB). Then to select specific days for control group and intervention group from the table, randomly moves his finger from a point in the random number table in a row or column direction. If a number between one and six is observed, its permutation will be noted. For example, if the number 6 appears, we note ABAB's permutation. In this way, the examination days will be allocated by the surgeon to intervention group (receiving training) and control group (without training).                                                                     
The method of sample selection in this research is done randomly using a random number table; so the researcher selects 10 people randomly from the list of people who have taken appointment for colorectal examinations on the mentioned surgeon visitation day. The researcher trains those 10 people in two rounds and two groups of five before being visited. Selection method in the control group will be the same. The control group members without training will complete the questionnaire 15 minutes before the visit, Blinding description: The blinding technique is like that those who give the questionnaires to patients and collect them, and the statistician who performs the data analysis do not know the groups, also a visitation day is assigned separately to the test group and another day is dedicated to the control group. Patients in the training group are asked to not talk about the information given in the training sessions with other people. Similarly, the necessary samples are collected.</study_design>
      <phase>N/A</phase>
      <hc_freetext>colorectal disease.</hc_freetext>
      <i_freetext>The intervention is a face-to-face educational psychoanalysis program.Intervention group:Intervention method: Training groups will be 4 to 6 people and the training is done in a classroom formed at the infirmary, the training class includes:A: Educational pamphlet provided to the learner at the beginning of the classB: PowerPoint using a computer and monitorThe training time will be 60 minutes. At the beginning of the session and before the training, the researcher gives the questionnaires to patients and asks them to complete those questionnaires, then the training begins by the researcher. According to the educational pamphlet, the researcher first outlines the importance of conducting these examinations and notes the dangers of non-timely examinations and its non-adherence. Then explains the examination method with the help of images that represent how the examination will be performed. These images are available on Pamphlet and PowerPoint; Images and explanations will be based on how to make such examinations scientifically as well as the special procedure of the surgeon. Through these images and descriptions, we help the patients to learn how to prepare themselves for examinations.                                                                                                          We explain to patients the cause of each question doctor asks and they will be asked to answer the questions correctly and tell the doctor real signs and symptoms in order to help the doctor identify the actual diagnosis. The duration of this training phase is estimated 30 minutes.                                                       After the training stage, the psychological preparation of patients begins. Fellow psychologist who is already coordinated with the research project, talks with patients and makes them mentally prepared to accept such examinations. The duration of this psychological counseling will be 30 minutes.                               During this psychological consultation, the group therapy will be used to solve the psychological aspect of this study. In such a way that in each session a group of 5 to 6 people will be settled under the college psychologist leadership and patients are asked to express all the negative emotions and thoughts, vague points, religious beliefs and their fears about these types of examinations and talk about the reason of these thoughts invasion and this kind of attitude toward this examination type. Then everyone in the group suggests a strategy and approach that considers as an appropriate solution to this problem and at the end, the best decision to solve the problem and accept these types of examinations will be provided by the group members under the management and leadership of fellow psychologist. In each session, the proposed solutions can be different with regard to the problems of the group members. Because decisions are made due to the members attitude and feelings in the same session. Also, there is a possibility that the proposed solution is different for each member of the same group.                                                                            At the end of the class, the patient's questions are answered and they wait for visitation. Immediately after the patients in the test group were examined by a doctor, they are requested again..</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>masoomeh rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3677 4254</telephone>
        <email>rambodm@sums.ac.ir</email>
        <affiliation>Shiraz university of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>masoomeh rambod</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>rambodm@sums.ac.ir</email>
        <affiliation>Shiraz university of medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age  range of 18-60 years
Tendency to participate in research
Possibility to attend the sessions in person, in the training group patients</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k59 , c18 </hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional intestinal  Benign neoplasm of colon, rectum, anus and anal canalMalignant neoplasm of colon</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention is a face-to-face educational psychoanalysis program.Intervention group:Intervention method: Training groups will be 4 to 6 people and the training is done in a classroom formed at the infirmary, the training class includes:A: Educational pamphlet provided to the learner at the beginning of the classB: PowerPoint using a computer and monitorThe training time will be 60 minutes. At the beginning of the session and before the training, the researcher gives the questionnaires to patients and asks them to complete those questionnaires, then the training begins by the researcher. According to the educational pamphlet, the researcher first outlines the importance of conducting these examinations and notes the dangers of non-timely examinations and its non-adherence. Then explains the examination method with the help of images that represent how the examination will be performed. These images are available on Pamphlet and PowerPoint; Images and explanations will be based on how to make such examinations scientifically as well as the special procedure of the surgeon. Through these images and descriptions, we help the patients to learn how to prepare themselves for examinations.                                                                                                          We explain to patients the cause of each question doctor asks and they will be asked to answer the questions correctly and tell the doctor real signs and symptoms in order to help the doctor identify the actual diagnosis. The duration of this training phase is estimated 30 minutes.                                                       After the training stage, the psychological preparation of patients begins. Fellow psychologist who is already coordinated with the research project, talks with patients and makes them mentally prepared to accept such examinations. The duration of this psychological counseling will be 30 minutes.                               During this psychological consultation, the group therapy will be used to solve the psychological aspect of this study. In such a way that in each session a group of 5 to 6 people will be settled under the college psychologist leadership and patients are asked to express all the negative emotions and thoughts, vague points, religious beliefs and their fears about these types of examinations and talk about the reason of these thoughts invasion and this kind of attitude toward this examination type. Then everyone in the group suggests a strategy and approach that considers as an appropriate solution to this problem and at the end, the best decision to solve the problem and accept these types of examinations will be provided by the group members under the management and leadership of fellow psychologist. In each session, the proposed solutions can be different with regard to the problems of the group members. Because decisions are made due to the members attitude and feelings in the same session. Also, there is a possibility that the proposed solution is different for each member of the same group.                                                                            At the end of the class, the patient's questions are answered and they wait for visitation. Immediately after the patients in the test group were examined by a doctor, they are requested again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anexiety_ embarrassment_ concern about judgment. Timepoint: Before intervention and after intervention. Method of measurement: Measurement of Beck's Anxiety Scale and measurement of embarrassment and concern are judgments of the medical embarrassment 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>Shiraz university of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-21</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Shiraz, Zand Avenue, opposite the Palestine Street, Central Building of Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
