<?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>IRCT20180120038444N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-27</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of aromatic  massage of lavender and chamomile on anxiety and sleep quality of patients with burns</public_title>
      <acronym></acronym>
      <scientific_title>Effect of aromatic  massage of lavender and chamomile on anxiety and sleep quality of patients with burns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29112</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization with 4-card blocking.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Burn.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: Under massage with aromatic chamomile and lavender oil (2 drops of pure lavender essential oil and 2 drops of pure chamomile essential oil, prepared from yellow firm, diluted in 30 cc of base oil of grape seed) on areas with healthy skin (legs Foot, back), 10 to 15 cc for 20 minutes, control group: day care group, placebo group: under baby massage with healthy skin (legs, back), 10 to 15 centimeters C, for 20 minutes.</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:
Total non-Identifiable Data, the Potential of the People Sharing

When:
Start Access 2018/5

To whom:
Professors and Students

Conditions:
-

Where to obtain:
ameri.f@tak.iums.ac.ir

How to obtain:
Request Via E-mail and Respond by Email Within one Week To Do

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery ,Rashid Yasemi St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>Ameri.f@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Ameri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Rashid Yasemi St,Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>Ameri.f@tak.iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 years
Awareness of time and place
Ability to speak and understand Persian language
Percentage of burns between 10-45% recorded in the file
Skin healthy areas of the leg or back
Lack of septicemia symptoms with regard to file information
72 hours after burn
Lack of physical disability
Degree 2 and 3 burns recorded in the case
Lack of mental disorder present and past recorded in the case
No history of asthma and allergies to plants
No history of blood pressure and migraine recorded in the file
Absence of self-immolation
Lack of pregnancy</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The sample's reluctance to continue cooperation
Sepsis in the study
Removal of the skin in healthy areas of the leg or back during the intervention
Sensitivity to massage oils used during the study
Patient's death</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Under massage with aromatic chamomile and lavender oil (2 drops of pure lavender essential oil and 2 drops of pure chamomile essential oil, prepared from yellow firm, diluted in 30 cc of base oil of grape seed) on areas with healthy skin (legs Foot, back), 10 to 15 cc for 20 minutes, control group: day care group, placebo group: under baby massage with healthy skin (legs, back), 10 to 15 centimeters C, for 20 minutes</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"The effect of aromatic massage with aromatic oil of lavender and chamomile on reducing anxiety and improving the quality of sleep in patients with burns", the primary outcome is the anxiety score in the Spielberger questionnaire and Pittsburgh Sleep Quality Score. Timepoint: Anxiety and quality of sleep are performed at the beginning of the study (before the intervention) and three days later (end of the intervention). Method of measurement: spielberger's anxiety scale, Pittsburgh Sleep Quality scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate and respiratory rate. Timepoint: Measurement of respiratory rate and heart rate in the first day (before and after intervention), second (before and after intervention) and third (before and after intervention). Method of measurement: Heart rate with digital pulse oximeter and manual breathing rate with clock aid.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-09</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
