<?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>IRCT20220726055560N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-11</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of watching animation in children's dentistry</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of Watching Dental and Non-Dental-Related Animations on Pain and Anxiety in 6-8 Year Old Children During Mandibular Nerve Block Injection</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>48</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65663</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: People were divided into three blocks of 8. Each block corresponded to one of three groups of related animation, unrelated animation, and control, into which subjects were assigned by selecting sealed envelopes.
Randomization method: limited (block). This method is used to create groups with equal numbers
Randomization Unit: Individual
Layers of randomization in case of using layered randomization: none
Randomization tool: sealed envelope
Creating a random sequence using Random allocation software
Opaque sealed envelopes with random sequence are used for concealment. In this method, a number of letter envelopes are prepared with aluminum foil (for the lack of clarity of the contents of the envelopes), and each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. Then the participants take one of the letter envelopes and open them, and the assigned group of that participant is revealed, Blinding description: Before entering the therapy department, children enter the room to watch the animation and then enter the therapy department with or without watching the animation. Therefore, the outcome assessor and the therapist are not aware of the conditions and do not have the right to question the child in this regard. Also, due to the coding of questionnaires and not determining the type of intervention, the analyst does not know the ratio of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pulp disease.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: once broadcast animation related to dentistry (practice in dentistry) for 15 minutes before starting the treatment in a quiet environment. Intervention 2: The second intervention group: once broadcast an animation not related to dentistry (mustrabin-hot sauce challenge) for 15 minutes before starting the treatment in a quiet environment. Intervention 3: Control group: patient entering the treatment room without playing the animation.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoume Danesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square - Medical Sciences Campus</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 1234 5678</telephone>
        <email>Nbh2020@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoume Danesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dr. Hasabi Square - Medical Sciences Campus</address>
        <city>Zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 1234 5678</telephone>
        <email>Nbh2020@yahoo.com</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 6 to 8 years
The presence of at least one asymptomatic molar requires non-emergency treatment and occupational therapy under mandibular nerve block anesthesia.
Absence of history of specific diseases and being healthy at the time of entering the study
Having natural intelligence (based on the child's behavior and speech)
The patient should be Frankel grade 3 or 4 in terms of cooperation
The patient does not have a history of dental treatment
No previous viewing of any of the two animations used in this study</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>8 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient should be Frankel grade 1 and 2 in terms of cooperation
During the study, the presence of a medical problem or the occurrence of certain diseases is diagnosed
Taking any pain reliever and sedative 48 hours before the injection
Dissatisfaction of parents to participate in this study
Allergy to anesthesia</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K04.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pulpitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: once broadcast animation related to dentistry (practice in dentistry) for 15 minutes before starting the treatment in a quiet environment.</i_keyword>
      <i_keyword>The second intervention group: once broadcast an animation not related to dentistry (mustrabin-hot sauce challenge) for 15 minutes before starting the treatment in a quiet environment.</i_keyword>
      <i_keyword>Control group: patient entering the treatment room without playing the animation</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety severity based on Venham test. Timepoint: Only when injecting local anesthesia. Method of measurement: Using Venham's visual test.</prim_outcome>
      <prim_outcome>Pain intensity based on Sound-Eye-Motor Scale (SEM). Timepoint: Only when injecting local anesthesia. Method of measurement: Using the SEM 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>Vice President of Research, Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-04</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Dr. Hasabi Square - Medical Sciences Pardis Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
