<?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>IRCT20230615058492N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-05</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of diaphragmatic breathing in reducing anxiety in patients undergoing treatment for crime.</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of diaphragmatic breathing (deep breathing) in reducing anxiety in patients undergoing scaling and root planing treatment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89631</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization is performed using the block random allocation method. First, using the PASS 2021 software, we generate a random sequence using the block random allocation method of 15 blocks of 4. The software output is in the form of an Excel file containing a sequence of numbers from one to 60 and a unique code for the research units. Eligible individuals are assigned numbers from one to 60 and are assigned to an intervention group (A or B). The first eligible individual to refer is assigned number 1, the second individual is assigned number 2, and so on, up to 60 patients are assigned to the groups. In order to blind the random assignment of the clients, we seek the help of a third person who is unaware of the interventions and this table is given to him. When the eligible person refers to the study, the third person is asked by voice over the telephone based on the individual number of the intervention group and the individual's assignment to one of the groups is determined and carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with periodontitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  In this group, patients are taught diaphragmatic breathing and during treatment, patients are asked to perform diaphragmatic breathing. Intervention 2: Control group:  This group is not given training and does not perform any actions during treatment.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Zare Mehrjardi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 35 3625 5881</telephone>
        <email>zahrazare3362@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Rashidi Maybodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square</address>
        <city>Yazd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8914881167</zip>
        <telephone>+98 35 3625 5881</telephone>
        <email>f_rashidi63@ssu.ac.ir</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 20 and 55 years
Need for scaling treatment (with accumulation of local factors and development of Stage II-IV periodontitis)
No previous experience with root canal treatment and root planing</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having heart or lung disease such as asthma
No smoking
No diagnosed mental health problems such as anxiety and depression
Not taking anti-anxiety medications
Not pregnant or breastfeeding
Not receiving chemotherapy; receiving painkillers; taking anti-anxiety or antidepressant medications; taking medications that affect heart rate and blood pressure, such as diuretics and beta-blockers; taking anticonvulsants; using immunosuppressant medications; or receiving local anesthesia during treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gingivitis and periodontal diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  In this group, patients are taught diaphragmatic breathing and during treatment, patients are asked to perform diaphragmatic breathing.</i_keyword>
      <i_keyword>Control group:  This group is not given training and does not perform any actions during treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental anxiety. Timepoint: Before the intervention, after two-thirds of the treatment. Method of measurement: Spielberger’s State-Trait Anxiety Inventory–State Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate. Timepoint: Before starting treatment, after completing two-thirds of the treatment. Method of measurement: Pulse oximeter device.</sec_outcome>
      <sec_outcome>Blood oxygen. Timepoint: Before starting treatment, after completing two-thirds of the treatment. Method of measurement: Pulse oximeter device.</sec_outcome>
      <sec_outcome>Systolic blood pressure. Timepoint: Before starting treatment, after completing two-thirds of the treatment. Method of measurement: Digital sphygmomanometer.</sec_outcome>
      <sec_outcome>Diastolic blood pressure. Timepoint: Before starting treatment, after completing two-thirds of the treatment. Method of measurement: Digital sphygmomanometer.</sec_outcome>
      <sec_outcome>Satisfaction from treatment. Timepoint: Immediately after treatment. Method of measurement: Ask questions in the questionnaire.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-02</approval_date>
        <contact_name>Ethics Committee of Faculty of Dentistry_ Shahid Sadoughi University of Medical Sciences, Yazd</contact_name>
        <contact_address>Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
