<?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>IRCT20220611055138N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-02</date_registration>
      <primary_sponsor>Babol University of Medical Sciences</primary_sponsor>
      <public_title>The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of mandala staining on nausea, vomiting and dry heaves in women with breast cancer undergoing chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>58</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64240</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: In this study, the samples will be selected from the patients referred to Yas Hospital based on the inclusion criteria, and then they will be placed in 4-block tables according to the order of referral and divided into intervention and control groups. In order to prevent information leakage, the implementation method and study objectives will be introduced to the people of the intervention group along with the necessary explanations, in a separate room.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Nausea. Condition 2: Breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the intervention: In the second session of chemotherapy, Rhodes nausea, vomiting and gag index are provided to the samples of both groups by providing complete explanations until immediately, one hour later and 12 hours after the end of chemotherapy by the patient Or their caregiver is completed and delivered to the researcher at the next chemotherapy session. Intervention: 1- Before the start of the third session, the researcher makes the necessary arrangements with the samples of the experimental group to attend half an hour before the start of chemotherapy.  2- In the third session, at the same time as prescribing the drugs before chemotherapy (ketril and dexamethasone), the researcher receives the questionnaire of the second session and gives one of the mandala designs along with the colored pencil to the patient in 20 minutes.  May paint accurately.  Immediately, one hour later and 12 hours after the end of chemotherapy, the Rhodes index is completed again by the patient or his caregiver and delivered to the researcher in the fourth session of chemotherapy.  Steps one and two will be repeated for the fourth session of chemotherapy. Intervention 2: Control group: People assigned to the control group will not receive any intervention other than chemotherapy. In order to compare the data, the Rhodes index will be completed before, one and 12 hours after chemotherapy by 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
.

When:
.

To whom:
.

Conditions:
.

Where to obtain:
.

How to obtain:
.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hengameh karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ramsar Fatemeh Zahra School Of Nursing</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4781955855</zip>
        <telephone>+98 11 5522 5151</telephone>
        <email>Hengamehkarimister@gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>hengameh karimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nursing faculty of ramsar</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4781955855</zip>
        <telephone>+98 11 5522 5151</telephone>
        <email>faezehghorbani97@ gmail.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 years and older
Literacy for the patient or caregiver
Interest and satisfaction to participate in the research
Treated with adriamycin and cyclophosphamide
Perform at least one chemotherapy session
Nausea, vomiting and dry heaves in the first session of chemotherapy (self-report)
Do not have another illness with nausea, vomiting and wheezing according to the file and self-report
Do not take any other medication with nausea, vomiting and nausea as reported and self-report
Do not use narcotics or sedatives according to the file and self-report
Absence of cognitive and psychiatric disorders (according to the file)
No impairment in vision and hearing
No defects or disabilities in the dominant hand so as to prevent staining.
Do not use self-medication or other complementary medicine to reduce nausea, vomiting and nausea</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Before the intervention: In the second session of chemotherapy, Rhodes nausea, vomiting and gag index are provided to the samples of both groups by providing complete explanations until immediately, one hour later and 12 hours after the end of chemotherapy by the patient Or their caregiver is completed and delivered to the researcher at the next chemotherapy session. Intervention: 1- Before the start of the third session, the researcher makes the necessary arrangements with the samples of the experimental group to attend half an hour before the start of chemotherapy.  2- In the third session, at the same time as prescribing the drugs before chemotherapy (ketril and dexamethasone), the researcher receives the questionnaire of the second session and gives one of the mandala designs along with the colored pencil to the patient in 20 minutes.  May paint accurately.  Immediately, one hour later and 12 hours after the end of chemotherapy, the Rhodes index is completed again by the patient or his caregiver and delivered to the researcher in the fourth session of chemotherapy.  Steps one and two will be repeated for the fourth session of chemotherapy.</i_keyword>
      <i_keyword>Control group: People assigned to the control group will not receive any intervention other than chemotherapy. In order to compare the data, the Rhodes index will be completed before, one and 12 hours after chemotherapy by the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Rhodes nausea, vomiting and dry heaves questionnaire score. Timepoint: In sessions two, three and four immediately, one hour and 12 hours after chemotherapy. Method of measurement: Nausea and vomitting  Rohds Index.</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>Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-29</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Telar 10, 17 shahrivar st, zirab, savadkooh, mazandaran Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
