<?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>IRCT20211213053379N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-28</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of foot massage and inhalation of peppermint drops on job stress and fatigue severity"</public_title>
      <acronym></acronym>
      <scientific_title>"Comparison of the effect of foot reflex massage and peppermint inhalation on job stress and fatigue severity in emergency medical technicians"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60670</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using a simple random method using random selection software (Random Allocation), people will be classified into three groups of intervention (foot massage), peppermint inhalation group and control group. In this table, the numbers from 1 to 69 will be classified, respectively, and each number will belong to a participant in each group who will be randomly assigned to that group by a computer, Blinding description: In this study, due to the type of intervention, it was not possible for the participant and the researcher to be blind. Therefore, to prevent bias, the statistical analyst will be unaware of the allocation of patients in groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Stress. Condition 2: Fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Reflexology massage of the soles of the feet with olive oil in 3 sessions for 40 minutes (20 minutes each leg). Intervention 2: Intervention group: Intervention group: Inhalation of peppermint drops by Barich Essential Oil Company with 10% concentration for 1 minute for 3 sessions after the mission of emergency medical technicians. Intervention 3: Control group: Control group: No intervention will be performed by this group. Only the ASIP job stress and FSS fatigue questionnaire will be completed by this group.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>End Of Azar 3, Chamran St., Imam St., Qeydar City</address>
        <city>Qeydar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4581917681</zip>
        <telephone>+98 24 3421 1721</telephone>
        <email>ShabaniMehdi109@Gmail.Com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>End Of Azar 3, Chamran St., Imam St.</address>
        <city>Qeydar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4581917681</zip>
        <telephone>+98 24 3421 1721</telephone>
        <email>ShabaniMehdi109@Gmail.Com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being employed as an emergency medical technician
No olfactory problems
Lack of sensitivity to peppermint</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>50 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Being under 22 years old or over 50 years old
Having olfactory problems and allergies to peppermint</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43</hc_code>
      <hc_code>T73.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Reaction to severe stress, and adjustment disorders</hc_keyword>
      <hc_keyword>Exhaustion due to exposure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Reflexology massage of the soles of the feet with olive oil in 3 sessions for 40 minutes (20 minutes each leg)</i_keyword>
      <i_keyword>Intervention group: Intervention group: Inhalation of peppermint drops by Barich Essential Oil Company with 10% concentration for 1 minute for 3 sessions after the mission of emergency medical technicians</i_keyword>
      <i_keyword>Control group: Control group: No intervention will be performed by this group. Only the ASIP job stress and FSS fatigue questionnaire will be completed by this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Job stress score in Esipio Job Stress Questionnaire. Timepoint: The amount of stress of the technicians at the beginning of the study (before the intervention) and the amount of stress one hour after the foot massage and inhalation of peppermint. Method of measurement: Osipow Job Stress Questionnaire.</prim_outcome>
      <prim_outcome>Fatigue severity score in FSS fatigue severity questionnaire. Timepoint: The degree of fatigue of technicians (before the intervention) and the degree of fatigue of technicians one hour after the intervention. Method of measurement: FSS Fatigue Intensity Questionnaire (fss).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Stress reduction score. Timepoint: Measure anxiety (before intervention) and one hour after intervention. Method of measurement: Questionnaire for 60 questions of ASPIO job stress.</sec_outcome>
      <sec_outcome>Fatigue reduction score. Timepoint: Measurement of drowsiness (before intervention) and one hour after intervention. Method of measurement: Short questionnaire 9 questions FSS fatigue severity (fss).</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>Zanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-30</approval_date>
        <contact_name>Ethics Committee of Zanjan University of Medical Sciences</contact_name>
        <contact_address>End of Azar 3, Chamran St., Imam St., Qeydar City Qeydar Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
