<?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>IRCT20190703044082N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-10</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of parsnip and vanilla scent on dental pain and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Vanilla aromatherapy and Orange aromatherapy on Pain and Anxiety in Children under Dental Procedures</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68761</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to randomly assign the participants to aromatherapy groups with orange essential oil, aromatherapy with vanilla essence and control, the names of the three groups will be written on paper and taken randomly, and the order of sampling of the groups will be determined. 20 blocks of 6 will be used for random allocation of samples in three groups. In this way, the letter A will be considered for the orange group, the letter B for the vanilla group, and the letter C for the control group. on pieces of paper, and we will pick them randomly. Then, according to the possible order of sampling, it will start, Blinding description: Patients are blinded to the allocation of which group they will be placed in. That is, children and their families are unaware of whether they have been placed in the orange or vanilla aromatherapy group or the control group. In addition, the person who analyzes the data is blinded to the assignment of individuals to groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Tooth Decay.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: In group A (orange aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of orange essential oil into the nebulizer. After 10 minutes, the children are subjected to dental procedures, and during the dental procedures, which averaged 30 minutes, orange aroma therapy (8 drops every two minutes) continues. Intervention 2: Intervention group: Intervention method: In group B (vanilla aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of vanilla essential oil into the nebulizer and adds 8 drops of vanilla essential oil every two minutes to intensify Do not reduce the scent. After 10 minutes, children are subjected to dental procedures. During the dental procedures, which averaged 30 minutes, vanilla aroma therapy (8 drops every two minutes) continues. Intervention 3: Control group: In group C, the researcher pours 80 cc of distilled water and 8 drops of placebo (distilled water) into the nebulizer and adds 8 drops of placebo to it every two minutes so that the severity of the pain does not decrease. After 10 minutes, children are subjected to dental procedures. Aromatherapy with placebo (8 drops every two minutes) continues during dental procedures, which averaged 30 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>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>Fateme Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3334 5634</telephone>
        <email>F-mohammadi@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children and their parents should be satisfied to participate in the study
8-12 year old children who need at least one decayed tooth treatment based on doctor's diagnosis.
Not having vision or hearing defects
Not having fever or illness
Not having physical or mental disorders.
Children should not undergo dental surgery
Children should not be under psychiatric or psychological treatment
The child's first visit to the dentist</inclusion_criteria>
      <agemin>8 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>1) Reluctance of parents and children to continue studying.
2) Being unpleasant or sensitive to the smell of orange or vanilla for the child.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K02.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dental caries, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In group A (orange aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of orange essential oil into the nebulizer. After 10 minutes, the children are subjected to dental procedures, and during the dental procedures, which averaged 30 minutes, orange aroma therapy (8 drops every two minutes) continues.</i_keyword>
      <i_keyword>Intervention group: Intervention method: In group B (vanilla aroma therapy), 10 minutes before any intervention by the dentist, the researcher pours 80 cc of distilled water and 8 drops of vanilla essential oil into the nebulizer and adds 8 drops of vanilla essential oil every two minutes to intensify Do not reduce the scent. After 10 minutes, children are subjected to dental procedures. During the dental procedures, which averaged 30 minutes, vanilla aroma therapy (8 drops every two minutes) continues.</i_keyword>
      <i_keyword>Control group: In group C, the researcher pours 80 cc of distilled water and 8 drops of placebo (distilled water) into the nebulizer and adds 8 drops of placebo to it every two minutes so that the severity of the pain does not decrease. After 10 minutes, children are subjected to dental procedures. Aromatherapy with placebo (8 drops every two minutes) continues during dental procedures, which averaged 30 minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety. Timepoint: Before and immediately after the procedure. Method of measurement: Modified Child Dental Anxiety Scale by Wang et al.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before and immediately after the procedure. Method of measurement: Wong and Baker pain rating scale.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-21</approval_date>
        <contact_name>Hamadan University of Medical Sciences (Research Ethics Committee)</contact_name>
        <contact_address>Hamedan, Shariati Crossroads, Ayatollah Kashani Boulevard, Hamedan University of Medical Sciences Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
