<?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>IRCT2016081726861N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-27</date_registration>
      <primary_sponsor>Vice Chancellor for research and technology of Kurdistan University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of the Effect of Lavender Essence and Chamomile Essence on pain severity after cesarean section</public_title>
      <acronym>-</acronym>
      <scientific_title>The Comparison of the Effect of Lavender Essence and Chamomile Essence on pain severity after cesarean section under spinal anesthesia: A blind placebo-controlled randomized clinical trial.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-02-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>129</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Random allocation is based on using the draw without placing a sealed envelope which contain number one, two or three. There are 129 sealed envelopes including 43 sealed envelopes contains number one for lavender essence group; 43 sealed envelopes contains number two for chamomile essence group and 43 sealed envelopes contains number three for placebo group.</study_design>
      <phase>2</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of lavender essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists. Intervention 2: Intervention group2: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of Chamomile essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists. Intervention 3: Placebo group: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of normal saline are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.</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>Baharreh Najafi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Besat Hospital, Keshavarz Street, Sanandaj</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6619616776</zip>
        <telephone>+98 87 3328 5910</telephone>
        <email>baharrehnajafi@yahoo.com; jamal.seidi@yahoo.com; jamal.seidi@muk.ac.ir</email>
        <affiliation>Kurdistan University of medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jamal Siedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj, code:66177-13446</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-13446</zip>
        <telephone>+98 87 3182 7464</telephone>
        <email>jamal.seidi@yahoo.com; jamal.seidi@muk.ac.ir</email>
        <affiliation>Kurdistan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria included: Cesarean section candidates (after surgery); being volunteer to participate in the study; lack of underlying medical conditions (diabetes, chronic respiratory disease, chronic heart disease, kidney or liver disorders and other acute or chronic disorders); surgery under spinal anesthesia; Get 100-mg diclofenac suppository in the recovery room; getting more than three scores of pain severity using the visual analog scale after surgery. Exclusion criteria included Patient’s unwillingness from continuing the study, and unpredicted events after surgery such as cardiac arrest or patient’s death.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N94</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain and other conditions associated with female genital organs and menstrual cycle</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of lavender essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.</i_keyword>
      <i_keyword>Intervention group2: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of Chamomile essence are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.</i_keyword>
      <i_keyword>Placebo group: in the case of having pain more than 3 scales; from discharging recovery till 6 hours after surgery; two drops of normal saline are poured on a ball of cotton and the patient is asked to inhale it. The intervention will be done just one time and the medical analgesics will be ordered If pain persists.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: As having pain more than 3 scales; from discharging recovery till 6 hours after surgery. Method of measurement: Based on Visual Analog Scale (VAS); severity of pain is recorded from zero to ten.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The rate of consumption of analgesic. Timepoint: after the intervention. Method of measurement: Based on the frequency of use and dose of medication in information sheet.</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>Vice Chancellor for research and technology of Kurdistan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-11</approval_date>
        <contact_name>Ethic committee of Kurdistan University of Medical Sciences</contact_name>
        <contact_address>Kurdistan University of Medical Sciences, after Qods Hospital, Pasdaran street, Sanandaj, postal code:13446-66177 Sanandaj  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
