<?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>IRCT20220104053628N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of diaphragmatic breathing on pain, sleep and fatigue in patients with metastatic gastrointestinal cancers</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial study The effect of diaphragmatic breathing on pain, sleep and fatigue in patients with metastatic gastrointestinal cancers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61369</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a simple random method using a card will be used. 2 types of cards A and B A total of 44 cards that
Where 22 cards A and 22 cards B and then the participant randomly picks up one of the cards and is placed in one of the control or test groups. The people who take the A card are in the test group and the rest are in the control group. Individuals in the experimental group are trained and breathing exercises are performed, but there is no training or intervention in the control group. The researcher registers the people and assigns them to the test and control groups in a simple random way with a card.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metastatic cancers of the gastrointestinal tract.</hc_freetext>
      <i_freetext>Intervention 1: "Intervention group": Intervention group: In the intervention group, diaphragmatic breathing will be performed for 10 days and twice a day (9 am and 9 pm) for 10 minutes. Diaphragmatic breathing is basically done in both supine and sitting positions. Patients are instructed to lie down: Participants lie comfortably on the bed, focusing on the lower abdomen, bending the knees, and using pillows under the legs as needed. For a sitting position, the knees are bent and one hand is placed on the upper chest and the other hand on the lower chest. Place the immobile tongue in the floor of the mouth, relax by taking a deep breath and exhaling it slowly. . Hold your breath for 2-5 seconds and then exhale slowly through your mouth. It is best to calm the environment as much as possible to prevent distractions and avoid talking during the process. Intervention 2: "Control group": There is no intervention in the 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>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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 9, Farhang Building, Moallem Town</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714895664</zip>
        <telephone>+98 83 3427 6319</telephone>
        <email>nasim_nina72@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Reza Abdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Kermanshah University of Medical Sciences.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714869914</zip>
        <telephone>+98 83 3427 6477</telephone>
        <email>a_abdi61@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction for cooperation
Diagnosis of metastatic gastrointestinal cancer based on the opinion of the treating physician
Age 18-50 years
No history of drug use
No history of debilitating musculoskeletal diseases
Periodic experience of chronic pain based on the tools of Van Korf et al
Periodic fatigue experience based on Piper tools
Periodic experience of sleep disorders based on the Petersburg instrument</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Death during the intervention period
Discharge from the oncology department during the intervention period
Decreased consciousness so that they are unable to continue cooperating during the intervention period</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C15-C26</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms of digestive organs</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>"Intervention group": Intervention group: In the intervention group, diaphragmatic breathing will be performed for 10 days and twice a day (9 am and 9 pm) for 10 minutes. Diaphragmatic breathing is basically done in both supine and sitting positions. Patients are instructed to lie down: Participants lie comfortably on the bed, focusing on the lower abdomen, bending the knees, and using pillows under the legs as needed. For a sitting position, the knees are bent and one hand is placed on the upper chest and the other hand on the lower chest. Place the immobile tongue in the floor of the mouth, relax by taking a deep breath and exhaling it slowly. . Hold your breath for 2-5 seconds and then exhale slowly through your mouth. It is best to calm the environment as much as possible to prevent distractions and avoid talking during the process.</i_keyword>
      <i_keyword>"Control group": There is no intervention in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary consequence is a pain management plan. Timepoint: Before the intervention and after 10 days. Method of measurement: Visual Analogue Scale. Chronic Pain Questionnaire by Van Korf et al.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome variable is improved sleep  seeking pain relief. Timepoint: Before the intervention and then 10 days after the intervention . Method of measurement: Petersburg Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>The secondary outcome variable of fatigue recovery seeks pain relief. Timepoint: Before the intervention and then 10 days after the intervention . Method of measurement: Piper Fatigue Scale Questionnaire.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-11</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>in front of Imam Ali Hospital, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
