<?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>IRCT20230704058670N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-17</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Virtual Reality on pain and anxiety during dental treatment in children</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Virtual Reality distraction on pain and anxiety during dental Treatment in children</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71084</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In order to randomly assign patients, the permutation block method will be used with a volume of 6. For this purpose, 5 blocks with a volume of 6 will be prepared by the RA software and will be available to the researchers. Each block will include 6 patients who will be divided into 2 intervention and control groups by one of the following modes: A: control group B: intervention group
AAABBB, AABABB,ABABAB,BBBAAA,.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Investigating distraction through virtual reality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the studied group, a virtual reality headset is used, which will play the movie from the screen of the phone. The children of the study group were asked to watch the film for 5 minutes before starting the dental treatment and after a little rest, watch the continuation of the film during the dental treatment. After the completion of the treatment, the headset will be removed. Clinical examination and radiographic evaluation will be performed for these children, and the milk molar teeth that require a single-session pulpotomy in the upper and lower jaws will be determined. Teeth with deep caries but Without symptoms, those who do not have swelling, abscess and fistula related to teeth, as well as laxity and movement in clinical examinations, are selected. Also, no periapical radiolucency should be seen in the radiograph. In pulpotomy, when the coronal pulp is removed, the bleeding should be easy to control and the bleeding should stop within 5 minutes after using a pressure pack. Intervention 2: Control group: In the control group, the traditional TSD behavioral guidance method will be used. The TSD method is one of the most common methods of behavioral management techniques, and it means that every dental procedure that is going to be performed on a child, the child must be well informed about it, so a demonstration is given to him using a simulator can be.</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>Sajedeh-Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yeganeh St., 105 Alley, Sub 9, No. 27</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814874595</zip>
        <telephone>+98 910 392 6170</telephone>
        <email>saberisajede78@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajedeh-Saberi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Yeganeh St., 105 Alley, Sub 9, No. 27</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8814874595</zip>
        <telephone>+98 910 392 6170</telephone>
        <email>saberisajede78@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with Frankl's behavior 3 and 4
Children  who are free from any psychological as well as systemic illness
Children without any anxiety disorders</inclusion_criteria>
      <agemin>4 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Children whose parents were not willing to give consent to the study
sensitivity to the motion or flash light or having accidents in the eyes, face, neck, or arms</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 - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the studied group, a virtual reality headset is used, which will play the movie from the screen of the phone. The children of the study group were asked to watch the film for 5 minutes before starting the dental treatment and after a little rest, watch the continuation of the film during the dental treatment. After the completion of the treatment, the headset will be removed. Clinical examination and radiographic evaluation will be performed for these children, and the milk molar teeth that require a single-session pulpotomy in the upper and lower jaws will be determined. Teeth with deep caries but Without symptoms, those who do not have swelling, abscess and fistula related to teeth, as well as laxity and movement in clinical examinations, are selected. Also, no periapical radiolucency should be seen in the radiograph. In pulpotomy, when the coronal pulp is removed, the bleeding should be easy to control and the bleeding should stop within 5 minutes after using a pressure pack.</i_keyword>
      <i_keyword>Control group: In the control group, the traditional TSD behavioral guidance method will be used. The TSD method is one of the most common methods of behavioral management techniques, and it means that every dental procedure that is going to be performed on a child, the child must be well informed about it, so a demonstration is given to him using a simulator can be.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score on the scale Faces version of the Modified Child Dental Anxiety Scale. Timepoint: Before and after the intervention. Method of measurement: Questionnaire of Faces version of the Modified Child Dental Anxiety Scale.</prim_outcome>
      <prim_outcome>Wong-Baker Faces pain scale. Timepoint: After the intervention. Method of measurement: Questionnaire of Wong-Baker faces pain scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The level of dissolved oxygen in the blood. Timepoint: Before the intervention and after the intervention. Method of measurement: Pulse oximetry device.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Before the intervention and after the intervention. Method of measurement: Pulse oximetry device.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-09</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences, Shahrekord, Iran</contact_name>
        <contact_address>Yeganeh St., 105 Alley, Sub 9, No. 27 Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
