<?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>IRCT20170131032329N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-26</date_registration>
      <primary_sponsor>Neyshabour University of Medical Sciences</primary_sponsor>
      <public_title>The effect of aromatherapy inhalation with geranium essence on physiological Parameter and post operative complications of appendectomy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of aromatherapy inhalation with geranium essence on physiological  Parameter and post operative complications of appendectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33655</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Other, Randomization description: In order to randomly assign individuals to the three groups and guaranteeing the balance of the number of people in groups, a random block method will be used.Sampling is done in several steps.In this study, the block size will be considered as six.Consequently, using randomized blocking, the participants randomly divided into three groups of aromatic herbal fragrances, aromatic herbs with a sweet almond and control group, Blinding description: Research units, as well as researcher's help, which measure pain intensity, are unaware of the nature of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>appendicitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the aromatherapy group with geranium essence three grams of aromatic geranium essential oil of 1% maked by Barij Essence company are poured onto a pad and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face. At this time, the patient is prepared for anesthesia. Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters a recovery, the patient is first responded with pain, nausea, vomiting and physiological symptoms. The patient is subjected to aromatherapy with geranium essence for a second time for 5 minutes, Immediately after the intervention and When the patient leaves the recovery (30 minutes after the patient's recovery) and 4 hours after the operation. Severity of pain, nausea, vomiting and physiological symptoms are recorded. Intervention 2: second intervention group: In the placebo group, during the delivery of the patient from the surgery ward to the operating room, a check list for pain intensity assessment according to the VAS scale, the visual scale of nausea and physiological indicators for the first time are completed and recorded.Patients with sweet almonds are inhaled.In the aromatherapy group with sweet almonds three drops of sweet almond essnce  are made by Barij Essence company pured on a pad, and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face.At this time, the patient is prepared for anesthesia.Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters recovery, the pain, nausea, vomiting and physiological symptoms are recorded at the first time that the patient is able to respond.The patient is subjected to a sweet almond oil for a second time for 5 minutes.Then immediately after the intervention and when the patient leaves the recovery(30 minutes after the patient enters the recovery)And 4 hours after the operation, the severity of pain, nausea, vomiting and physiological symptoms are recorded. Intervention 3: Control group: In the control group, no intervention is performed and only the severity of the pain and vomiting and physiological indices in the mentioned stages are recorded and recorded, and patients are only treated with routine care.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Abavisani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyshabur University of Medical Science, Razi Ave</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9315647483</zip>
        <telephone>+98 51 4222 5411</telephone>
        <email>mahnazabavisani@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Abavisani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neyshabur University of Medical Science, Razi Ave</address>
        <city>Neyshabur</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9315647483</zip>
        <telephone>+98 51 4222 5411</telephone>
        <email>Mahnazabavisani@gmail.com</email>
        <affiliation>Neyshabour University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfied to participate in the study
Appendectomy is undergoing open procedure
Under general anesthesia
After surgery, they are alert and have no known cognitive or psychological disorder
Patients with anesthesia risks 1 and 2
The age of patients is between 15 and 45 years
Do not consume drugs and not addicts
Do not have a history of allergies and allergies
There are no known underlying diseases
Duration of surgery should not exceed one hour
Do not have NG tube</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The occurrence of any unexpected complications during an intervention that prevents further work with the patient, such as a severe reduce in blood pressure and other complications that may interfere with the patient's experience
Deny the patient from participating in the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>(K35-K38)</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>(K00-K93)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the aromatherapy group with geranium essence three grams of aromatic geranium essential oil of 1% maked by Barij Essence company are poured onto a pad and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face. At this time, the patient is prepared for anesthesia. Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters a recovery, the patient is first responded with pain, nausea, vomiting and physiological symptoms. The patient is subjected to aromatherapy with geranium essence for a second time for 5 minutes, Immediately after the intervention and When the patient leaves the recovery (30 minutes after the patient's recovery) and 4 hours after the operation. Severity of pain, nausea, vomiting and physiological symptoms are recorded.</i_keyword>
      <i_keyword>second intervention group: In the placebo group, during the delivery of the patient from the surgery ward to the operating room, a check list for pain intensity assessment according to the VAS scale, the visual scale of nausea and physiological indicators for the first time are completed and recorded.Patients with sweet almonds are inhaled.In the aromatherapy group with sweet almonds three drops of sweet almond essnce  are made by Barij Essence company pured on a pad, and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face.At this time, the patient is prepared for anesthesia.Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters recovery, the pain, nausea, vomiting and physiological symptoms are recorded at the first time that the patient is able to respond.The patient is subjected to a sweet almond oil for a second time for 5 minutes.Then immediately after the intervention and when the patient leaves the recovery(30 minutes after the patient enters the recovery)And 4 hours after the operation, the severity of pain, nausea, vomiting and physiological symptoms are recorded.</i_keyword>
      <i_keyword>Control group: In the control group, no intervention is performed and only the severity of the pain and vomiting and physiological indices in the mentioned stages are recorded and recorded, and patients are only treated with routine care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score according to VAS scale. Timepoint: Measuring the intensity of pain when entering the operating room, when the patient enters recovery in the first time that the patient is able to respond, when leaving the recovery, 4 hours after surgery. Method of measurement: VAS Scale.</prim_outcome>
      <prim_outcome>Vomiting Nausea Score based on the visual scale of the severity of nausea. Timepoint: Before entering the operating room, after entering the recovery, immediately after the second intervention, before leaving the recovery, 4 hours after the operation. Method of measurement: the visual scale of the severity of nausea.</prim_outcome>
      <prim_outcome>Physiological Indices. Timepoint: Before entering the operating room, before induction of anesthesia, before the operation, after the completion of the operation, after entering the recovery, immediately after the second intervention, before leaving the recovery. Method of measurement: Using finger pulse oximeter and monitoring device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Neyshabour University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Neyshabour University of Medical Sciences</source_name>
      <source_name>Neyshabour University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-08</approval_date>
        <contact_name>Ethics committee of Neyshabur University of Medical Sciences</contact_name>
        <contact_address>NO 489, North Asadabadi 17, North Arg Ave Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
