<?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>IRCT20220717055481N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Compare of two ways of Emotional Self-Regulation Strategies and Systematic Desensitization for fear and anxiety reduction</public_title>
      <acronym></acronym>
      <scientific_title>Comparing of effectiveness of Emotional Self-Regulation Strategies and Systematic Desensitization on Fear and Anxiety of Adults referred to Dentistry</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65336</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization, block is used to balance the number of samples allocated for one of studying' groups to be equal the size of all blocks in groups. In this study, size of all 20 blocks (20 participants in group 1, 20 participants in group 2 and 20 participants in control group). Unit of individual randomization: individuals with stress specified by dentist and individuals who tend to participate in pretest. We made use of randomization statistical software, random allocation using Random' software and also allocation concealment way to prevent of its clearing. We could not determine the allocated group before individual’s allocation due to prevention of weak randomization process. We used opaque sealed envelopes with a random sequence, in which each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, numbering is done on the outer surface of the envelopes in the same order. Finally, the lids of the envelopes are glued and placed in a box in order. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Effecs of systematic desensitization and emotional regulation strategies upon fear and anxiety's reduction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Emotional Self-regulation. The emotional self-regulation method that was taught for 8 sessions of 1.5 hours is based on Gross's theoretical model, which includes five stages (situation selection, situation modification, attention expansion, cognitive expansion, and response adjustment), each of which is a set of strategies includes an adjustment. Participants were taught to identify and correct negative emotion regulation strategies and replace them with positive strategies. Intervention 2: Control Group: Pre and posttest were conducted on control group, however, they were not delivered any instruction. The research method were introduced in detail. Intervention 3: Intervention group 2: Systematic Desensitization.The systematic desensitization method that was taught for 8 sessions of 1.5 hours is based on relaxation,hierarchy of anxiety,desensitization.Participants were taught to confront situational anxiety and state of relaxiation.</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 No information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Akbar Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Talegani Ave,PayameNoor</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5173865955</zip>
        <telephone>+98 41 3310 7209</telephone>
        <email>Parivar90@yahoo.com</email>
        <affiliation>PayameNoor</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parivar Masumeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Roshdiyeh</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5173865955</zip>
        <telephone>+98 41 3310 7209</telephone>
        <email>Parivar90@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having dental problems
Need to perform dental intervention
Satisfaction to participate in the research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Individuals above 20 years old
Individuals who have dental fear and anxiety and we study such individuals to be able to help them to decrease their fear and anxiety.</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>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Emotional Self-regulation. The emotional self-regulation method that was taught for 8 sessions of 1.5 hours is based on Gross's theoretical model, which includes five stages (situation selection, situation modification, attention expansion, cognitive expansion, and response adjustment), each of which is a set of strategies includes an adjustment. Participants were taught to identify and correct negative emotion regulation strategies and replace them with positive strategies.</i_keyword>
      <i_keyword>Control Group: Pre and posttest were conducted on control group, however, they were not delivered any instruction. The research method were introduced in detail.</i_keyword>
      <i_keyword>Intervention group 2: Systematic Desensitization.The systematic desensitization method that was taught for 8 sessions of 1.5 hours is based on relaxation,hierarchy of anxiety,desensitization.Participants were taught to confront situational anxiety and state of relaxiation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is dental fear and anxiety. Timepoint: Investigating the effect of two methods on fear and anxiety before the start of the study (before the intervention) and 60 days after the intervention. Method of measurement: Questionnaire of dentistry'anxiety  by Staterd and Melberg &amp;Hogstraten, Questionnaire of dentistry'fear by Cutbert &amp; Melamed.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-17</approval_date>
        <contact_name>Ethics committee of Tabriz Islamic Azad university</contact_name>
        <contact_address>Saye2,kaje 12 Ave.,South Sarvestan Street,Roshdiyeh,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
