<?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>IRCT20210306050603N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-12</date_registration>
      <primary_sponsor>Artesh University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on anxiety, pain and quality of life in patients with inflammatory bowel disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on anxiety, pain and quality of life in patients with inflammatory bowel disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/54892</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be divided into experimental and control groups by simple randomization method, Blinding description: Patients are divided into experimental (pressure) and control (touch) groups by simple randomization method and the patient does not know her group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: bowel syndrome disease(Ulcerative colitis). Condition 2: bowel syndrome disease(Crohn's disease).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pressure is applied at the pressure points determined in the study. After teaching these points and how to do it by the researcher in person, it is recommended that the intervention be performed three times a day for four weeks. During these four weeks, the researcher monitors the intervention daily by phone. Anxiety, pain and quality of life questionnaires are completed by the patient before the intervention and four weeks after the intervention. The pressure points are selected from st, kid, sp, and li4 pressure points according to the opinion of the acupressure specialist. Intervention 2: Control group: Touching is performed at the pressure points specified in the study. The training is performed by the researcher in person. Touch the pressure points three times a day for four weeks. The researcher monitors the intervention daily by telephone. The patient completes the Anxiety, Pain and Quality of Life questionnaires before the intervention and four weeks after the intervention. The pressure points are selected from st, kid, sp, and li4 pressure points according to the opinion of the acupressure specialist.</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 Due to the fact that this research has been approved by the military university, we are not allowed to publish these cases</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Hospital،Shahid Fakhrizadeh St.،Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1693716617</zip>
        <telephone>+98 21 2795 1428</telephone>
        <email>zahraabasi6506@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Chamran Hospital،Shahid Fakhrizadeh St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1693716617</zip>
        <telephone>+98 21 2795 1428</telephone>
        <email>zahraabasi65065@gmail.com</email>
        <affiliation>Artesh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients are diagnosed with inflammatory bowel disease
Patients are not in acute health condition
Patients range in age from 18 to 60 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients in need of emergency medical procedures are not included in the study
A patient who is unwilling to participate in the project</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
      <hc_code>K50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
      <hc_keyword>Crohn's disease [regional enteritis]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pressure is applied at the pressure points determined in the study. After teaching these points and how to do it by the researcher in person, it is recommended that the intervention be performed three times a day for four weeks. During these four weeks, the researcher monitors the intervention daily by phone. Anxiety, pain and quality of life questionnaires are completed by the patient before the intervention and four weeks after the intervention. The pressure points are selected from st, kid, sp, and li4 pressure points according to the opinion of the acupressure specialist.</i_keyword>
      <i_keyword>Control group: Touching is performed at the pressure points specified in the study. The training is performed by the researcher in person. Touch the pressure points three times a day for four weeks. The researcher monitors the intervention daily by telephone. The patient completes the Anxiety, Pain and Quality of Life questionnaires before the intervention and four weeks after the intervention. The pressure points are selected from st, kid, sp, and li4 pressure points according to the opinion of the acupressure specialist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: Short form of IBDQ-9 quality of life questionnaire.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: Spielberger Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>The pain. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: Visual numerical questionnaire for pain intensity.</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>Artesh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-01-06</approval_date>
        <contact_name>Ethics committee of Aja University of Medical Sciences</contact_name>
        <contact_address>Shariati Ave. Kaj Ave. Aja Nursing College. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
