<?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>IRCT201102264775N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-06-15</date_registration>
      <primary_sponsor>University of Medical Scienecs Shiraz</primary_sponsor>
      <public_title>The effect of hypnotherapy on irritable bowel syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of hypnotherapy on gastrointestinal  symptoms severity,anxiety scores and quality of life in patients with irritable bowel syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2010-12-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/5099</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Irritable Bowel Syndrom.</hc_freetext>
      <i_freetext>Intervention 1: After obtaining the written letter of satisfaction to take part in the research and completing demographic questionnaire  by physician, the usual treatment (drug-therapy) was started for patients and then was introduced to researchers. Thereafter, these patients were divided into two control and intervention groups as Block randomization. At the next stage, three weeks from beginning of treatment and introducing patient to researcher, the Hypnotism of patient was carried out in sessions of one hour and in the presence of third person (except Hypnotizer and patient) for the intervention group. The first Hypnotherapy was carried out in the beginning of forth week of research and again it was done in the beginning of sixth week by scientific method. In these sessions, creating fatigue in eyes and muscular relaxation, creating concentration and Hypnotism, going deep into Hypnotism via reinforcement of imaginations and mental incarnation, giving positive and effective inculcations were educated. Lightening the Hypnotism and sending patient out of it was finally taken place. Intervention 2: Hypnotherapy did not carry out for control group.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery College, Namazi Squer</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>mohebbi04@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zinat Mohebbi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery College, Namazi squer</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4256</telephone>
        <email>mohebbi04@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: having ages between 20 to 60 years; possessing the literacy of at least primary fifth class; IBS diagnosis by gastroenterologist; having at least three months history of suffering from IBS disease and being under the IBS usual therapeutic program; showing propensity of participating in hypnotherapy sessions and filling the written letter of satisfaction. Exclusion criteria: suffering from other gastrointestinal diseases or recognized psychical disease; being under other therapeutic programs like homeopathy, relaxation etc.; having the symptoms of reflux and functional dyspepsia; cancer history in individual or family; having anemia and positive stool test for parasite or blood</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K58.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>irritable bowel syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After obtaining the written letter of satisfaction to take part in the research and completing demographic questionnaire  by physician, the usual treatment (drug-therapy) was started for patients and then was introduced to researchers. Thereafter, these patients were divided into two control and intervention groups as Block randomization. At the next stage, three weeks from beginning of treatment and introducing patient to researcher, the Hypnotism of patient was carried out in sessions of one hour and in the presence of third person (except Hypnotizer and patient) for the intervention group. The first Hypnotherapy was carried out in the beginning of forth week of research and again it was done in the beginning of sixth week by scientific method. In these sessions, creating fatigue in eyes and muscular relaxation, creating concentration and Hypnotism, going deep into Hypnotism via reinforcement of imaginations and mental incarnation, giving positive and effective inculcations were educated. Lightening the Hypnotism and sending patient out of it was finally taken place.</i_keyword>
      <i_keyword>Hypnotherapy did not carry out for control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastrointestinal  symptoms included abdominal pain, feeling cramp above abdomen, nausea and vomiting, borborygmus, abdominal distension, constipation, diarrhea, loose stool, solid stool, feeling urgent defecation and feeling tenesmus. Timepoint: 3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week. Method of measurement: Gastrointestinal Symptom Rating Scale.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: 3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week. Method of measurement: IBS specific quality of life.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: 3 weeks before intervention,The begining of forth week ,The begining of sixth week,The begining of fifth week. Method of measurement: Spielberger State Trait Anxiety Inventory(SSTAI).</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>University of Medical Scienecs Shiraz</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-12-29</approval_date>
        <contact_name>Vice Chancellor for research and technology, Shiraz University of Medical Sciences</contact_name>
        <contact_address>Central Building Shiraz University of Medical Sciences, Zand Street Shiraz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
