<?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>IRCT20100921004787N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-31</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>Effect rose essential on nausea and vomiting of chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation effect of aromatherapy with rose essential  on nausea and vomiting in patients undergoing chemotherapy: A randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65005</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: All eligible patients will be divided using the block randomization method with the size of 4 and 6 blocks equally (ratio 1:1) into aromatherapy groups with rose essence and control. Sealed Envelope Ltd.'s online randomization service will be used to generate the randomization list. Also used for concealment are sequentially numbered opaque sealed envelopes(SNOSE).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Nausea and vomiting severity after chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The group in which severity of nausea and vomiting are evaluated once in three hours before chemotherapy. Then, in the patient's room, five minutes before the start of chemotherapy, 3 drops of rose essential with a concentration of 40%, which is from an Iranian plant company(Lavender), is poured on sterile gauze 5*5, then the gauze is adjusted so that it is connected to the patient's collar by a pin at the closest distance (twenty centimeters) to the patient's nose. then the patient is asked  to breathe normally for three minutes, and  this is done  every time before each cycle of chemotherapy. After the end of the chemotherapy session, the severity of nausea and vomiting of the client will be evaluated during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs. Intervention 2: Control group: A group in which no intervention is used as a placebo because of the smell of roses. So the severity of nausea and vomiting will be assessed once in a three-hour period before chemotherapy. Also, after the end of the chemotherapy session, the severity of nausea and vomiting of the patients will be examined during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs.</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:
All original data can be shared after de-identifying individuals.

When:
Beginning of access from 2023

To whom:
Researchers of universities of medical sciences

Conditions:
Raw data is not made available to everyone. If using published results, reference should be made to the article. The requesting researcher is allowed to carry out this method in similar studies.

Where to obtain:
Pouria Takasi; email: pooryapin380@gmail.com
Tahereh Khaleghdoost Mohammdi; email: khaleghdoost@gums.ac.ir

How to obtain:
First, send your request via email. If approved, the requested information will be sent in one working week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Pouria Takasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Daneshjoo Street, Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3326 2950</telephone>
        <email>Pooryapin380@gmail.com</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Khaleghdoost Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Daneshjoo Street, Shahid Beheshti Highway, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4146939841</zip>
        <telephone>+98 13 3355 3202</telephone>
        <email>khaleghdoost@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Having the experience of at least one cycle of chemotherapy
The ability to understand and speak Persian
Prescribing chemotherapy drugs that are classified as severe in terms of nausea and vomiting.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The presence of hepatitis
Suffering from brain malignancies and other metastases
Allergy to herbal medicines and essential oils
Lack of sense of smell</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and vomiting</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The group in which severity of nausea and vomiting are evaluated once in three hours before chemotherapy. Then, in the patient's room, five minutes before the start of chemotherapy, 3 drops of rose essential with a concentration of 40%, which is from an Iranian plant company(Lavender), is poured on sterile gauze 5*5, then the gauze is adjusted so that it is connected to the patient's collar by a pin at the closest distance (twenty centimeters) to the patient's nose. then the patient is asked  to breathe normally for three minutes, and  this is done  every time before each cycle of chemotherapy. After the end of the chemotherapy session, the severity of nausea and vomiting of the client will be evaluated during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs.</i_keyword>
      <i_keyword>Control group: A group in which no intervention is used as a placebo because of the smell of roses. So the severity of nausea and vomiting will be assessed once in a three-hour period before chemotherapy. Also, after the end of the chemotherapy session, the severity of nausea and vomiting of the patients will be examined during three six-hour intervals using the Visual Analogue Scale tool. These patients will follow all the doctor's prescriptions and usual care such as taking anti-nausea drugs, corticosteroids, benzodiazepines and other drugs.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting severity. Timepoint: Measuring the severity of nausea and vomiting once three hours before the intervention and then in three six-hour intervals after the intervention. Method of measurement: Visual Analogue Scale.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-13</approval_date>
        <contact_name>Ethics committee of Guilan University of Medical sciences</contact_name>
        <contact_address>Student of Nursing and Midwifery faculty, Shahid Beheshti Highway, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
