<?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>IRCT2017060422320N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-03</date_registration>
      <primary_sponsor>Vice chancellor of Research, Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy with essential oils of rose on blood pressure in patients with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy with essential oils of rose on blood pressure in patients with hypertension Bahraman city of Rafsanjan in 2016</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19266</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: In the control group, sesame oil is filtered and odorless as a placebo. Patients are subjected to aromatherapy for 2 consecutive days for 2 minutes and for 2 weeks by inhalation, three drops of placebo on cotton, at a distance of 5 cm from the nose under the aromatherapy. One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays) after the start of aromatherapy, and the ten minutes of rest are performed by a specific person at the clinic. To ensure the use of placebo, the checklist for the exact completion of aromatherapy is completed by the patient and delivered to the researcher. Intervention 2: In the aroma group, the essential oil of Mohammadi is diluted on the basis of filtered sesame oil, and is used as an additive. Patients in the aroma group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation.&#13;
One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. To ensure essential oil consumption, the exact checklist for aromatherapy is completed by the patient and delivered to the researcher.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Tayebe Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718796755</zip>
        <telephone>+98 34255900</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Major entry into the study includes the fact that blood pressure is detected by controlling the blood pressure recorded in the previous three periods; Having primary blood pressure; Having hypertension in stage 1 and 2; Healthy feeling; Not having sensitivity to the essential oil of the flower of Mohammadi and a history of allergies or respiratory diseases. The main outcomes of the study include the patient's reluctance to continue studying; Sensitization during the implementation of the plan; Lack of cooperation in referring to the health center for controlling blood pressure; Neuropsychiatric patients taking medication and illnesses that cause the patient to use drugs that alter blood pressure during research.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>IX 110</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension Incl.: High blood pressure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the control group, sesame oil is filtered and odorless as a placebo. Patients are subjected to aromatherapy for 2 consecutive days for 2 minutes and for 2 weeks by inhalation, three drops of placebo on cotton, at a distance of 5 cm from the nose under the aromatherapy. One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays) after the start of aromatherapy, and the ten minutes of rest are performed by a specific person at the clinic. To ensure the use of placebo, the checklist for the exact completion of aromatherapy is completed by the patient and delivered to the researcher.</i_keyword>
      <i_keyword>In the aroma group, the essential oil of Mohammadi is diluted on the basis of filtered sesame oil, and is used as an additive. Patients in the aroma group undergo aromatherapy at a distance of 5 cm from the nose for 2 minutes and for 2 weeks by inhalation.&#13;
One day before the intervention, the blood pressure of the patients is taken with a digital blood pressure device. Blood pressure measurement is performed on days 2, 5, 9, 12, and 16 (Mondays, Thursdays, Mondays, Thursdays, and Mondays), and is followed by ten minutes of rest by a specific person at the clinic. To ensure essential oil consumption, the exact checklist for aromatherapy is completed by the patient and delivered to the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hypertension. Timepoint: Before the intervention, 2,5,9,12 days after, two days after intervention. Method of measurement: Blood pressure in millimeters of mercury using a digital blood pressure.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pulse. Timepoint: Before the intervention, 2,5,9,12 days after, two days after completion of the intervention. Method of measurement: In terms of pulse rate using a digital blood pressure.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id>ندارد</sec_id>
        <issuing_authority>ندارد</issuing_authority>
      </secondary_id>
      <secondary_id>
        <sec_id>ندارد</sec_id>
        <issuing_authority>ندارد</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice chancellor of Research, Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-04-18</approval_date>
        <contact_name>Rafsanjan University of Medical Sciences ethics committee</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan Rafsanjan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
