<?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>IRCT20230704058668N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-19</date_registration>
      <primary_sponsor>university of Karbala</primary_sponsor>
      <public_title>Slow Deep Breathing Exercises upon Fatigue Level</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Slow Deep Breathing Exercises upon Fatigue Level among Patients Undergoing Chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71091</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>cancer.</hc_freetext>
      <i_freetext>Intervention group: Appling slow deep breathing through the nose while the mouth was closed and keep it on for few second and then exhale slowly through the mouth. This exercise was performed for 15-20 min twice daily for seven days..</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:
Effectiveness of Slow Deep Breathing Exercises upon Fatigue Level among Patients Undergoing Chemotherapy

When:
the data will be available at the end of July

To whom:
any researcher who is interested in this data.

Conditions:
The data could be used after getting permission via email. Also, users need to acknowledge the owner

Where to obtain:
Users can ask for the data and permission via email. Zahraa Jasim Alwan is the corresponding author. He will contact whoever he requests the information from. His email is zahraa.j@s.uokerbala.edu.iq. The address is Al-Hur district, Karbala, Iraq. What processes are involved for a request to access data/document

How to obtain:
Users can ask for the data and permission via email. Zahraa Jasim Alwan is the corresponding author. He will contact whoever he requests the information from. His email is zahraa.j@s.uokerbala.edu.iq.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahraa Jasim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>officers neighborhood, Karbala</address>
        <city>Karbala city center</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 782 723 2988</telephone>
        <email>zahraa.j@s.uokerbala.edu.iq</email>
        <affiliation>university of Karbala/ College of nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahraa Jasim Alwan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>officers neighborhood, Karbala</address>
        <city>Karbala city center</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 782 723 2988</telephone>
        <email>zahraa.j@s.uokerbala.edu.iq</email>
        <affiliation>university of Karbala/ College of nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with cancer undergoing chemotherapy.
Patients undergoing two cycles at least</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who don’t have nausea or fatigue.
Patient with impaired verbal communication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y43.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>fatigue as a side effects of chemotherapy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Appling slow deep breathing through the nose while the mouth was closed and keep it on for few second and then exhale slowly through the mouth. This exercise was performed for 15-20 min twice daily for seven days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the level of fatigue related to chemotherapy that can be changed based on slow deep breathing exercise. Timepoint: Before intervention and after 7 days of intervention. Method of measurement: fatigue severity scale will be used to measure fatigue level.</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>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-03</approval_date>
        <contact_name>Ethics committee in college of Nursing University of Karbala</contact_name>
        <contact_address>officers neighborhood, Karbala Karbala city center Holy Kerbala Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
