<?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>IRCT20260414069075N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-05</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Aromatherapy with Orange and Peppermint Scents on Reducing Nausea, Vomiting, and Anxiety in Children Undergoing Chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Aromatherapy with Orange and Peppermint Essential Oils on Nausea, Vomiting, and Anxiety in Children with Cancer Undergoing Chemotherapy Referred to Hospitals and Clinics Affiliated with Shiraz University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/89480</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization process will utilize permuted block randomization to assign the participants to the three study groups. A total of 120 participants will be allocated using 20 blocks of size six, Blinding description: The data analyst will be blinded to the allocation of groups to active intervention or placebo groups to prevent potential bias in interpretation the results. The allocation of groups will be disclosed to the analyst once the analysis is fully completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Nausea and Vomiting. Condition 2: Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In the orange essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of orange essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes. Intervention 2: Intervention group: In the peppermint essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of peppermint essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes. Intervention 3: Control group:  In the placebo group, in addition to routine ward care, aromatherapy will be simulated using two drops of liquid paraffin placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.</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 Its release schedule is not yet known</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and midwifery school, Namazi square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>nargesrahimi.hr@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Neda Jamali Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school, Namazi square, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>nedajamali21@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 9–12 years of both genders
Ability to understand and speak Persian
No history of hypersensitivity, allergic rhinitis, and asthma or known respiratory problems
Having a healthy sense of smell
Receiving chemotherapy with drugs that have moderate to severe emetogenic potential
Not having  diseases that lead to vomiting
The patient’s ability to determine the severity of nausea, vomiting, and anxiety according to the protocol
No history of psychological problems or anxiety disorders according to self-report
No use  of sedative or anxiolytic drugs
A history of receiving at least one session of chemotherapy, and reporting nausea and vomiting after that</inclusion_criteria>
      <agemin>9 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of willingness of the child and parents to perform the intervention
Sensitivity to herbal essential oils
Use of other complementary medicine methods</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In the orange essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of orange essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.</i_keyword>
      <i_keyword>Intervention group: In the peppermint essential oil aromatherapy group, in addition to routine ward care, aromatherapy will be administered using two drops of peppermint essential oil placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.</i_keyword>
      <i_keyword>Control group:  In the placebo group, in addition to routine ward care, aromatherapy will be simulated using two drops of liquid paraffin placed on a 2x2 cm gauze pad. This pad will be attached to the child's collar with a pin, 20 cm from the child's nose. The child will be asked to breathe normally for twenty minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea score on the Adapted Rhodes Index of Nausea and Vomiting for Pediatric. Timepoint: Before intervention, 12 and 24 hours after chemotherapy. Method of measurement: Adapted Rhodes Index of Nausea and Vomiting for Pediatric.</prim_outcome>
      <prim_outcome>Vomiting score on the Adapted Rhodes Index of Nausea and Vomiting for Pediatric. Timepoint: Before intervention, 12 and 24 hours after chemotherapy. Method of measurement: Adapted Rhodes Index of Nausea and Vomiting for Pediatric.</prim_outcome>
      <prim_outcome>Anxiety score on the Spielberger's State-Trait Anxiety Inventory for Children. Timepoint: Before intervention, 12 and 24 hours after chemotherapy. Method of measurement: Spielberger's State-Trait Anxiety Inventory for Children.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-31</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery school, Namazi square, Shiraz Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
