<?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>IRCT20210412050939N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-01</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with Citrus aurantium essential oil and foot reflexology on relieve cancer pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with Citrus aurantium essential oil and foot reflexology on relieve pain in patients with cancer undergoing chemotherapy in hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55551</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random randomization will be done by web randomization method and using the website https://www.sealedenvelope.com/.The assignment sequence will be determined by first assigning the letters A, B, C, and D to each of the study groups. The size of the blocks will be eight (twice the number of groups), but the size of the blocks is not said by the researcher so that the person doing the sampling is not aware of it and can not predict how to allocate and in Prevent selection error. After listing almost all possible modes, six blocks, and assigning a number to each of them using a random number table, a number of blocks will be selected to increase the sample size to 160, Blinding description: To blind the researcher, the pain assessment of the samples before and after the intervention is done by an assistant researcher who will also be unaware of the allocation of study groups. Also, the analyzer will not know about the study groups and will analyze the data only with the codes that are considered for each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first experimental group, aromatherapy with spring orange in such a way that with a dropper of three drops of 10% essential oil of spring orange, Barich essential oil is poured on the gas and placed in a box 30 cm away from the patient's head. From the intervention and one hour after the intervention, it will be completed for three days (that is, 3 times before the intervention and 3 times after the intervention, the pain assessment sheet will be completed).In order to prevent the possible occurrence of allergy to spring orange essential oil in other patients who are present in the ward but are not included in this study, we will try to study in more secluded rooms with a maximum of two beds, as well as for other patients in the room. There are also tests for sensitivity to essential oils, will be performed by the said method. Intervention 2: Intervention group: In the second test group, reflexology of the sole of the foot will be performed for half an hour according to the pain points. During this study, each night before the intervention and one hour after the intervention for three nights, the subjects were asked to complete the pain measurement tool. Intervention 3: Intervention group: In the third experimental group, plantar reflexology and aromatherapy with spring orange essential oil simultaneously. Intervention 4: Control group: In the control group, the samples will not receive any kind of massage, reflexology or fragrance and will receive only the usual care of the ward.</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 data is potentially shareable after unidentified individuals.

When:
Access period starts from 2021

To whom:
The data will be available to researchers from academic and scientific institutions.

Conditions:
Researchers will only be allowed access to advance academic research goals.

Where to obtain:
It will be possible to receive documents in the dissertation bank of the Central Library of Zanjan University of Medical Sciences.

How to obtain:
It will be possible to receive documents in the dissertation bank of the Central Library of Zanjan University of Medical Sciences.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoomeh Mortagha Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3314 8263</telephone>
        <email>mmortaghyghasemy@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoomeh Mortagha Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zanjan University of Medical Sciences</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4513956184</zip>
        <telephone>+98 24 3314 8263</telephone>
        <email>mmortaghyghasemy@yahoo.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be at least 18 years old
The person is able to understand Persian and speak Persian and is willing to participate in the study
Have a pain score of at least 3 based on the VAS scale before the intervention
Platelets above 50,000 in Reflexology groups
Positive olfactory test in aromatherapy groups
Negative sensitivity testing in aromatherapy groups</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of knowledge of time, place and person
Lack of full consciousness
Existence of known mental disorders
Having Deep vein thrombosis
Having coagulation disorders
Acute skin problems and infections and skin lesions
Existence of open wounds in the legs
Existence of recent burns
Existence of fractures
Extensive bruises on the legs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z92.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Personal history of antineoplastic chemotherapy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first experimental group, aromatherapy with spring orange in such a way that with a dropper of three drops of 10% essential oil of spring orange, Barich essential oil is poured on the gas and placed in a box 30 cm away from the patient's head. From the intervention and one hour after the intervention, it will be completed for three days (that is, 3 times before the intervention and 3 times after the intervention, the pain assessment sheet will be completed).In order to prevent the possible occurrence of allergy to spring orange essential oil in other patients who are present in the ward but are not included in this study, we will try to study in more secluded rooms with a maximum of two beds, as well as for other patients in the room. There are also tests for sensitivity to essential oils, will be performed by the said method.</i_keyword>
      <i_keyword>Intervention group: In the second test group, reflexology of the sole of the foot will be performed for half an hour according to the pain points. During this study, each night before the intervention and one hour after the intervention for three nights, the subjects were asked to complete the pain measurement tool.</i_keyword>
      <i_keyword>Intervention group: In the third experimental group, plantar reflexology and aromatherapy with spring orange essential oil simultaneously</i_keyword>
      <i_keyword>Control group: In the control group, the samples will not receive any kind of massage, reflexology or fragrance and will receive only the usual care of the ward.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score on the VAS scale. Timepoint: Measure the pain score before and one hour after the intervention. Method of measurement: VAS 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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-11</approval_date>
        <contact_name>Ethics committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
