<?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>IRCT20230320057758N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-28</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of lavender scent on the side effects of smoking</public_title>
      <acronym></acronym>
      <scientific_title>The effect of lavender aromatherapy on boredom, severity of anxiety, cognitive function, clinical factors in smokers users</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-07-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups for example: the even numbers are for intervention group and the odd numbers are for the placebo group, Blinding description: In order to blind the presenters and patients, oil and placebos are placed in separate packages with codes 1 and 2.</study_design>
      <phase>3</phase>
      <hc_freetext>Nicotine dependence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then, patients are given vials containing lavender essential oil, which is provided by Barij Essential Oil Company, and they are asked to put two drops of it on a cotton ball every night before going to sleep for 15 days and breathe slowly for 20 minutes. slow At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again. Intervention 2: Control group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then vials containing distilled water, which are in the shape and size of the vials of the intervention group, are obtained from Barij Essans Company, are given to the patients and they are asked to drink two drops of them every night before going to bed for 15 days. Put it on cotton and breathe slowly for 20 minutes. At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amir ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Faculty of Medicine</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 3457 4191</telephone>
        <email>gaderiam@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amir ghaderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kashan University of Medical Sciences, Faculty of Medicine</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715981151</zip>
        <telephone>+98 31 3457 4191</telephone>
        <email>gaderiam@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness of participants to enter the experiment
Age range 18-49 years
Not having a chronic disease, including mental illness or diabetes, blood pressure or heart disease, hepatitis, etc.
All people who are smoking or have not quit smoking for a long time and their Fagerstrom score is at least 4.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>49 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Taking any kind of drugs
Any chronic physical disease that is newly diagnosed and interferes with the test results, including diabetes, high blood pressure, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F17.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nicotine dependence, cigarettes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then, patients are given vials containing lavender essential oil, which is provided by Barij Essential Oil Company, and they are asked to put two drops of it on a cotton ball every night before going to sleep for 15 days and breathe slowly for 20 minutes. slow At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again.</i_keyword>
      <i_keyword>Control group: includes 40 participants. In this group, before the intervention, tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are taken from the participants. Then vials containing distilled water, which are in the shape and size of the vials of the intervention group, are obtained from Barij Essans Company, are given to the patients and they are asked to drink two drops of them every night before going to bed for 15 days. Put it on cotton and breathe slowly for 20 minutes. At the end, the intervention tests of impatience, anxiety, cognitive function, as well as clinical factors including blood pressure, heart rate and blood oxygen are received from the participants again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Boredom score of MSBS questionnaire. Timepoint: Completing the questionnaire before the intervention and on the 15th day of the intervention. Method of measurement: MSBS questionnaire.</prim_outcome>
      <prim_outcome>Expression intensity by Hamilton questionnaire. Timepoint: Completing the questionnaire before the intervention and on the 15th day of the intervention. Method of measurement: Hamilton Anxiety Severity Questionnaire.</prim_outcome>
      <prim_outcome>Cognitive performance score of MoCA questionnaire. Timepoint: Completing the questionnaire before the intervention and on the 15th day of the intervention. Method of measurement: MoCA Cognitive Function Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score of Petersborg Sleep Disorder Questionnaire. Timepoint: Completing the questionnaire before the intervention and on the 15th day of the intervention. Method of measurement: Petersburg Sleep Disorder Questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure measurement. Timepoint: Measurement before the intervention and day 15 of the intervention. Method of measurement: Blood pressure measuring device.</prim_outcome>
      <prim_outcome>Heart rate measurement. Timepoint: Measurement before the intervention and day 15 of the intervention. Method of measurement: Heart rate monitor.</prim_outcome>
      <prim_outcome>Blood oxygen measurement. Timepoint: Measurement before the intervention and day 15 of the intervention. Method of measurement: Blood oxygen measuring device.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-12</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences, Faculty of Medicine, Kashan, Iran kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
