<?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>IRCT20220910055931N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-23</date_registration>
      <primary_sponsor>Isfahan University of Medical Sciences Research Assistant</primary_sponsor>
      <public_title>The effect of aromatherapy with geranium essential oil on children's anxiety</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of aromatherapy using geranium essential oil compared to water on patients' anxiety during dental procedures in children 6-9 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Sampling is done from among the qualified clients in an easy and random way up to the required sample size to divide the patients into two groups and what intervention should be done for each patient in the first and second sessions in envelopes labeled as two groups. Intervention/Control) It is written that the patients are asked to choose an envelope as they wish and they are placed in one of two groups based on the title inside the envelope.</study_design>
      <phase>2</phase>
      <hc_freetext>Anxiety caused by dental treatments.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Each child needed two treatments, and all children were treated between 8 and 9 in the morning, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, he took it out and put it in a glass tube. Geranium essential oil was used in this research, which was purchased from Gol Sanam Sepid Company. This essential oil contains geraniol with 15.88%, citronellol with 27.2% and linalool with 10.38%.Aromatherapy was performed using an aroma diffuser (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water with 3 drops of essential oil into the tank, then the device spread the fragrance of geranium flowers with a frequency of 50-60 Hz in the air of a room with an area of ​​10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory. Intervention 2: Control group: Each child needed two treatments, and all children were treated between 8 and 9 am, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, it was taken out and placed in a glass tube.Aromatherapy with water was done by an aroma diffuser device (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water into the tank, then the device, with a frequency of 50-60 Hz, spread water vapor in the air of a room with an area of ​​10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory.</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:
Data is shared after de-identifying individuals

When:
Access starts 6 months after the publication of the article

To whom:
Researchers and students

Conditions:
If people cannot be identified

Where to obtain:
Sofeh Blvd., Isfahan Faculty of Dentistry, Dr. Homa Bani Najarian
Email: H. Baninajarian@yahoo.com

How to obtain:
For use in future studies

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Homa Baninajarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23، SHahid etezadi Ave، Azar Ave، Mottahari Ave، Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8133743744</zip>
        <telephone>+98 913 386 8194</telephone>
        <email>H.baninajarian@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Baninajarian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 23، SHahid etezadi Ave، Azar Ave، Mottahari Ave، Esfahan Town</address>
        <city>Esfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8133743744</zip>
        <telephone>+98 913 386 8194</telephone>
        <email>H.baninajarian@yahoo.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children aged 6 to 9 years who need fissure sealant treatment
No history of toothache
Absence of systemic problems and physical and mental disabilities
It has Frankel + and ++ collaboration criteria</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>9 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with the first visit to the dentist
Children with a history of allergies and suffering from colds and respiratory diseases and smell disorders
Patients with spontaneous pain</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Phobic anxiety disorders</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: Each child needed two treatments, and all children were treated between 8 and 9 in the morning, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, he took it out and put it in a glass tube. Geranium essential oil was used in this research, which was purchased from Gol Sanam Sepid Company. This essential oil contains geraniol with 15.88%, citronellol with 27.2% and linalool with 10.38%.Aromatherapy was performed using an aroma diffuser (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water with 3 drops of essential oil into the tank, then the device spread the fragrance of geranium flowers with a frequency of 50-60 Hz in the air of a room with an area of ​​10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory.</i_keyword>
      <i_keyword>Control group: Each child needed two treatments, and all children were treated between 8 and 9 am, and the second visit was done the following week at the same time. In each visit, first the child was separated from his parents by a nurse and transferred to a room. After 5 minutes, a nurse recorded heart rate using a finger-type pulse monitor (Nonin, Chicago, USA) and unstimulated saliva by placing an absorbent cotton ball sublingually (Salivette, Sarstedt Inc. , Newton, NC, Chicago, USA). After 5 minutes, it was taken out and placed in a glass tube.Aromatherapy with water was done by an aroma diffuser device (operation mode: ultrasonic sound vibration). The tank volume of the device was 150 ml, and in this study, we poured 100 ml of water into the tank, then the device, with a frequency of 50-60 Hz, spread water vapor in the air of a room with an area of ​​10 square meters. All these works were done half an hour before the first patient entered the room. We used the same dental procedure on both occasions, which is a fissure sealant therapy for one of the first permanent molars, which was performed by a senior student of pediatric dentistry. It is done which consists of cleaning the teeth with a handpiece at low speed and a brush with rotating bristles.After completing the treatment, the nurse took a saliva sample and recorded the pulse rate and labeled it as the second sample. . In another visit, dental treatment was performed and samples were taken following the same method, and the third and fourth samples were collected. By collecting four samples from each child, a total of 120 samples were obtained. At the end of each round, the samples were sent to the laboratory.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Salivary cortisol. Timepoint: Measurement of salivary cortisol in the first and second sessions before dental work and re-measurement approximately 15 minutes later. Method of measurement: Measurement of salivary cortisol with salivary cortisol kit.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Heart rate measurement in the first and second sessions before dental work and re-measurement about 15 minutes later. Method of measurement: Pulse oximeter 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>Isfahan University of Medical Sciences Research Assistant</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-22</approval_date>
        <contact_name>Ethical Committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>No. 23, Shahid Motazadi Alley., Azar Ave., mottahari Ave esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
