<?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>IRCT20200521047526N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-11-10</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rhythmic breathing exercise on nausea and vomiting due to chemotherapy in breast cancer patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rhythmic breathing exercise on nausea and vomiting due to chemotherapy in breast cancer patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-06-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50430</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples were selected from outpatient chemotherapy patients first by purposive method and then by block randomization method by first preparing 6 blocks of 6 as follows: AAAAAA, AAAAAB, AAAABB, AAABBB, …… ..
  These blocks are randomly assigned to two groups according to A and B without regular placement. This action continues continuously until the sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Malignant neoplasm of breast.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: These patients are trained after the patients in the intervention group received the initial dose last month and experienced nausea and vomiting. Thus, before starting the second dose of chemotherapy, the technique of regular breathing is taught in the form of abdominal breathing along with routine interventions. In this technique, you have to focus on the diaphragm to breathe. The steps of this technique will be fully explained to the patient by the researcher. These steps include: Lying on the bed, placing your right hand on your chest and your left hand on your abdomen, taking a deep breath through your nose for three seconds, to see how your abdomen inflates and your upper chest stretches. Can be noted, then exhale slowly for four seconds, this action is done through the clock in the ward. The patient is asked to do this 10 times slowly and in situations where Note your inhale and exhale. This technique should be performed by the patient as soon as he or she feels chemotherapy-induced nausea. To ensure patient learning, regular breathing techniques are practiced for each patient under the supervision of a researcher. Because focusing on the diaphragm may not be palpable to the patient, focusing on the abdomen is used instead of the term diaphragm in teaching the technique of regular breathing. Intervention 2: Control group: There are people in the study for whom only standard methods of treating the side effects of chemotherapy are considered.</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>Hamidreza Karimifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Shiroodi St.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3813899589</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>Hamidrezakarimifard91@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Karimifard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Shiroodi St.</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3813899589</zip>
        <telephone>+98 86 3313 6055</telephone>
        <email>Hamidrezakarimifard91@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The person is undergoing chemotherapy with Adriamycin-Cyclophosphamide regimen.
The person has taken at least one dose of chemotherapy and experienced nausea and vomiting afterwards.
The person does not have digestive disorders.
The person is not diagnosed with anxiety disorders and depression</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: These patients are trained after the patients in the intervention group received the initial dose last month and experienced nausea and vomiting. Thus, before starting the second dose of chemotherapy, the technique of regular breathing is taught in the form of abdominal breathing along with routine interventions. In this technique, you have to focus on the diaphragm to breathe. The steps of this technique will be fully explained to the patient by the researcher. These steps include: Lying on the bed, placing your right hand on your chest and your left hand on your abdomen, taking a deep breath through your nose for three seconds, to see how your abdomen inflates and your upper chest stretches. Can be noted, then exhale slowly for four seconds, this action is done through the clock in the ward. The patient is asked to do this 10 times slowly and in situations where Note your inhale and exhale. This technique should be performed by the patient as soon as he or she feels chemotherapy-induced nausea. To ensure patient learning, regular breathing techniques are practiced for each patient under the supervision of a researcher. Because focusing on the diaphragm may not be palpable to the patient, focusing on the abdomen is used instead of the term diaphragm in teaching the technique of regular breathing.</i_keyword>
      <i_keyword>Control group: There are people in the study for whom only standard methods of treating the side effects of chemotherapy are considered.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea. Timepoint: It should be noted that patients have been advised to perform the above technique immediately whenever they feel nauseous within 72 hours after the second round of chemotherapy. In his first contact (uniformly at 10 pm after the second round of chemotherapy), the researcher asked the patient about the first severity of nausea after performing the regular breathing technique in the last 12 hours with the VAS questionnaire (result of intervention in this part of the patient's severity of nausea Then at the same time and every 12 hours every 3 days the Rhodes questionnaire (6 times) will be completed (the result of intervention in this section is the total score of the Rhodes questionnaire from the occurrence of nausea and vomiting every 12 hours). In fact VAS questionnaire only 1 time at 12 hours after chemotherapy will be accomplished and Rhodes questionnaire 6 times per 12 hours during 3 days will be filled. Method of measurement: Questionnaire and Index of Nausea and Vomiting Form 2 (INV-2).</prim_outcome>
      <prim_outcome>Vomiting. Timepoint: It should be noted that patients have been advised to perform the above technique immediately whenever they feel nauseous within 72 hours after the second round of chemotherapy. In his first contact (uniformly at 10 pm after the second round of chemotherapy), the researcher asked the patient about the first severity of nausea after performing the regular breathing technique in the last 12 hours with the VAS questionnaire (result of intervention in this part of the patient's severity of nausea Then at the same time and every 12 hours every 3 days the Rhodes questionnaire (6 times) will be completed (the result of intervention in this section is the total score of the Rhodes questionnaire from the occurrence of nausea and vomiting every 12 hours). In fact VAS questionnaire only 1 time at 12 hours after chemotherapy will be accomplished and Rhodes questionnaire 6 times per 12 hours during 3 days will be filled. Method of measurement: Questionnaire and Index of Nausea and Vomiting Form 2 (INV-2).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-28</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>University Complex of the Great Prophet (PBUH), Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
