<?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>IRCT20231027059871N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-23</date_registration>
      <primary_sponsor>University of Baghdad/ College of Nursing</primary_sponsor>
      <public_title>Reducing Nausea and Vomiting in Patient-Related Chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>"Effect of Massage and Aromatherapy on Nausea and Vomiting of Patient with Chemotherapy: A Randomized Control Trial"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74188</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to maintain a transparent and scientific-based randomization process, simple randomization will use three cards of different colors in a box for the sample to select one card that represents the group of the study. The yellow card represents the aromatherapy group, the blue card represents the massage group, and the black card represents the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chemotherapy Induced Nausea and Vomiting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Massage therapy group: Patients receive regular massage sessions during chemotherapy in the foot area for 15 minutes using peppermint oil. Intervention 2: Intervention group: Aromatherapy group: All patients were male and female lying in the supine position in the chemotherapy administration unit. Three drops of peppermint oil were placed with a dropper on a sterile gauze that was tied around the participants' collar for inhalation for 10 minutes while taking chemotherapy. After that, the Rhodes Index Scale was measured to evaluate the severity of nausea and vomiting 24 hours after taking the therapeutic dose. Intervention 3: Control group: Patients receive standard chemotherapy care without additional interventions.</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:
The researcher acknowledges that the scientific community has verifiable findings from the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed, reputable journals

When:
Once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution

Where to obtain:
The author's professional email that will be available with the published manuscript can be used to contact the author. e-Mail: karrarhassan220@gmail.com

How to obtain:
N/A

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Karrar Hassan Abd AL Sada</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5, Al-Dhahab Street., Al-Jamiya District</address>
        <city>Al -Zubaidiyah</city>
        <country1>Iraq</country1>
        <zip>70001</zip>
        <telephone>+964 772 372 7372</telephone>
        <email>karrar.abd2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Karrar Hassan Abd Al Sada</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5, Al-Dhahab Street., Al-Jamiya District,</address>
        <city>Al Zubaidiyah</city>
        <country1>Iraq</country1>
        <zip>70001</zip>
        <telephone>+964 772 372 7372</telephone>
        <email>karrar.abd2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad / College of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult patients aged 18 and above diagnosed with cancer and undergoing chemotherapy
Read and write
Patients experiencing nausea and vomiting
Have no problems communicating
Fully conscious.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Skin ulcer
Patients with a history of psychiatric disorders
Respiratory diseases like asthma
Patients with a history of allergy to massage oil or aromatherapy
Patients who have problems communicating and are unconscious</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant (primary) neoplasm, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Massage therapy group: Patients receive regular massage sessions during chemotherapy in the foot area for 15 minutes using peppermint oil.</i_keyword>
      <i_keyword>Intervention group: Aromatherapy group: All patients were male and female lying in the supine position in the chemotherapy administration unit. Three drops of peppermint oil were placed with a dropper on a sterile gauze that was tied around the participants' collar for inhalation for 10 minutes while taking chemotherapy. After that, the Rhodes Index Scale was measured to evaluate the severity of nausea and vomiting 24 hours after taking the therapeutic dose.</i_keyword>
      <i_keyword>Control group: Patients receive standard chemotherapy care without additional interventions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and Vomiting-related Chemotherapy. Timepoint: After 24 hours from intervention. Method of measurement: Rhodes Index Scale                                                                                                                  Rhodes index of nausea, vomiting and retching (24 hours after chemotherapy).</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>University of Baghdad/ College of Nursing</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-22</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>5, Al-Jamiya District., Gold Street Al-zubaidiya Wasit Governorate Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
