<?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>IRCT20230502058053N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-27</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of acupressure on injection pain of local anesthesia</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure at the LI4 point on injection pain of local anesthesia in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>23</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: With a coin flip randomization, each participant allocates to intervention or control (placebo) in the first session, Blinding description: Participants and outcome evaluators are not familiar with acupressure techniques. And all the steps in the control (placebo) and intervention sessions are as same as each other, but in the control (placebo) session, LI4 acupoint will be touched.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The pain of local anesthesia injection.</hc_freetext>
      <i_freetext>Intervention 1: With the flip of a coin, it is determined that each participant will receive the acupressure intervention or the control in the first session. So, if the acupressure intervention is performed in the first session, the control intervention will be performed in the second session and vice versa. Intervention session: Acupressure is performed by only one trained person. The acupoint LI4 (He Gu) is identified on the back surface of the hand and halfway between the first and second metacarpal bones (a little closer to the second metacarpal). Acupoint stimulation is done by pressing the thumb for 2 seconds and ten times. Then pressure is continuously applied for 10 seconds. And finally, the pressure is applied again for 2 seconds and ten times. The same procedure is repeated for the opposite hand. After that, the required dental injection is performed. Injection with 2% lidocaine; epinephrine 1.80000 is done in the maximum amount of 1.8 cc and one person does all the injections. Intervention 2: Control session (placebo): In this session as a sham, all the process mentioned in the previous section will be done, with the difference that the LI4 point is only touched by considering the mentioned times.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Patients confidentiality</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hanieh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 4279 4025</telephone>
        <email>h-moghimi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hanieh Moghimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۳۹۹۵۵۹۹۱</zip>
        <telephone>+98 21 4279 4025</telephone>
        <email>h-moghimi@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with an American Society of Anesthesiologists physical status of I or II
Children with a Frankl behavior scale of 3 (positive) or 4 (definitely positive)
Not receiving analgesics or sedatives at least 12 hours before the procedure
Needing nerve block or supra periosteal injection (same injection technique for 2 sessions)</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Be familiar with acupressure techniques
Limitation on the acupoint like ulcers or bruise
Needing for needle re-entry during injection
Local or systemic infection</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>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>With the flip of a coin, it is determined that each participant will receive the acupressure intervention or the control in the first session. So, if the acupressure intervention is performed in the first session, the control intervention will be performed in the second session and vice versa. Intervention session: Acupressure is performed by only one trained person. The acupoint LI4 (He Gu) is identified on the back surface of the hand and halfway between the first and second metacarpal bones (a little closer to the second metacarpal). Acupoint stimulation is done by pressing the thumb for 2 seconds and ten times. Then pressure is continuously applied for 10 seconds. And finally, the pressure is applied again for 2 seconds and ten times. The same procedure is repeated for the opposite hand. After that, the required dental injection is performed. Injection with 2% lidocaine; epinephrine 1.80000 is done in the maximum amount of 1.8 cc and one person does all the injections.</i_keyword>
      <i_keyword>Control session (placebo): In this session as a sham, all the process mentioned in the previous section will be done, with the difference that the LI4 point is only touched by considering the mentioned times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain of dental injection. Timepoint: During injection and 5 minutes after injection. Method of measurement: 1)face, legs, activity, cry, consolability scale 2) faces pain scale-revised.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-22</approval_date>
        <contact_name>Ethics committee of school of dentistry of Tehran University of Medical Sciences</contact_name>
        <contact_address>School of dentistry of Tehran University of Medical Sciences, next to Atomic Energy Organization, North Karegar St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
