<?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>IRCT20111015007803N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-29</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effects  of Inhalation of Rosa Damascene Essential Oil  on Fatigue and Anxiety among Cancer Patients Receiving Chemotherapy</public_title>
      <acronym></acronym>
      <scientific_title>The Effects  of Inhalation of Rosa Damascene Essential Oil on Fatigue and Anxiety among Cancer Patients Receiving Chemotherapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of sampling in this study was simple random sampling. How to place the selected samples in the test and control group based on the random number block method. From the first patient, one of the letters A and B was randomly selected. The first patient in the experimental group and the second patient in the control group were placed and then the patients were placed in the test and control groups, respectively. 32 patients in the experimental group and 32 patients in the control group were considered, Blinding description: This study is a double-blind clinical trial in which patients, who measure the outcomes of the study (the researcher), are unaware of how the patients received the intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>People with cancer under chemotherapy.</hc_freetext>
      <i_freetext>Intervention 1: The  fatigue and anxiety levels of the patients were assessed by a researcher  before  intervention using the BFI and Spielberger questionnaires.  by the assistant  Using a pipette,  distilled water  was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.The patients in the  intervention group in addition to the usual nursing care, inhaled 5 drops of damask rose essential oil 40% Prepared by the pharmacist, for 20 min,  for 3 day  consecutive  , while  In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients'  anxiety 20 minutes after intervention  by  using the Spielberger's questionnaire  .researcher measured Patients'  fatigue in 30 and 60 minutes after intervention  by  using the  BFI questionnaire. Intervention 2: Control group: The  fatigue and anxiety levels of the patients were assessed by a researcher  before  of intervention using the BFI and Spielberger questionnaires.  by the assistant  Using a pipette,  distilled water was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.  In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients'  anxiety 20 minutes after intervention  by  using the Spielberger's questionnaire  .researcher measured Patients'  fatigue in 30 and 60 minutes after intervention  by  using the  BFI questionnaire.</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 total potential data can be shared after unidentifiable people

When:
Starting the access period from 1397

To whom:
Elham Khosrobeigi

Conditions:
The total potential data after unidentifiable people is for sharing analysis

Where to obtain:
elhamkhosrobeigi65@yahoo.com

How to obtain:
Print in magazine

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Khosrobeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak, Shahid Rajai Avenue., Qodusi Blvd., Moshtaqi Alley</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3818787480</zip>
        <telephone>+98 634120497</telephone>
        <email>elhamkhosrobeigi65@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Zohreh Parsa Yekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zargandeh St., Southern Attary Moghaddam St., Knowledge Alley, Islamic Azad University, Tehran Medical Sciences</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1916893813</zip>
        <telephone>+98 21220066607</telephone>
        <email>Zparsa@tums.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age greater than 18 and less than 70 years
Cancer patients with at least one chemotherapy course with a 21 day interval from the last session.
Detect stage 2, 3, and 4 of all cancers other than head and neck and lung with the opinion of the relevant physician.
Full vigilance
No history of cigarette and drug addiction
Earning a score higher than 20 after responding to the Spielberger questionnaire in the pre-test
Non-use of benzodiazepines, tranquillizers and opioids during intervention
Without a history of migraine and chronic headaches
Non-impaired sense of smell (without obstruction and nasal congestion) and healthy sense of smell) through smelling of alcohol).
Inability of the patient to answer questions (in terms of physical and mental status)
lack of patient psychiatric problems (hospitalization or other medical treatment is not due to mental disorders).
Stable and stable hemodynamic status
Not having a history of allergy to the smell of herbs and any scent or fragrance
Not having respiratory diseases
The desire to participate in research
Do not use any other scent during the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with head and neck cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C80.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The  fatigue and anxiety levels of the patients were assessed by a researcher  before  intervention using the BFI and Spielberger questionnaires.  by the assistant  Using a pipette,  distilled water  was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.The patients in the  intervention group in addition to the usual nursing care, inhaled 5 drops of damask rose essential oil 40% Prepared by the pharmacist, for 20 min,  for 3 day  consecutive  , while  In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients'  anxiety 20 minutes after intervention  by  using the Spielberger's questionnaire  .researcher measured Patients'  fatigue in 30 and 60 minutes after intervention  by  using the  BFI questionnaire.</i_keyword>
      <i_keyword>Control group: The  fatigue and anxiety levels of the patients were assessed by a researcher  before  of intervention using the BFI and Spielberger questionnaires.  by the assistant  Using a pipette,  distilled water was dropped on a 10 × 10 cm gauze which was attached to the collar of the patient's shirt, about 20 cm from their nose.  In the control group, addition to the usual nursing care, the patients inhaled five drops of distilled water as placebo through the same procedure. researcher measured Patients'  anxiety 20 minutes after intervention  by  using the Spielberger's questionnaire  .researcher measured Patients'  fatigue in 30 and 60 minutes after intervention  by  using the  BFI questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue of patients with cancer under chemotherapy. Timepoint: Before the intervention and 30, 60 minutes after the intervention for three consecutive days. Method of measurement: Standard Fatigue Fatigue Questionnaire (BFI).</prim_outcome>
      <prim_outcome>Anxiety in patients with cancer under chemotherapy. Timepoint: Before the intervention and 20 minutes after the intervention for three consecutive days. Method of measurement: Spilberger Situational Anxiety Inventory.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-26</approval_date>
        <contact_name>The Ethics Committee of Islamic Azad University, Tehran Medical Branch</contact_name>
        <contact_address>Shariati St., Khaghani St. - Islamic Azad University, Tehran Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
