<?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>IRCT20221204056709N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-31</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Mindfulness Based Stress Reduction Therapy in Improving Oral Lichen Planus Disease</public_title>
      <acronym>MBSR</acronym>
      <scientific_title>The Effectiveness of Mindfulness Based Stress Reduction (MBSR) Therapy on  Psychological Distress among Patients with Oral Lichen Planus</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67290</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: According to the Inclusion Criteria, 50 patients with oral lichen planus were purposefully selected and placed in the intervention group and the control group through random assignment using a table of random numbers. In this method, the first selected number (randomly) is placed in the intervention group and the next number is placed in the control group, Blinding description: The blindness of the participants in the treatment is that they do not know that there is another group, but after the end, they will be informed about the existence of another group, and if they wish, the treatment will be done for them. The researcher is aware of the existence of the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral Lichen Planus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mindfulness Based Stress Reduction was created by Kabat-Zinn (1990), This Treatment is an Eight Week Evidence based Program. The Main Contents of the Treatment are: a) Relaxation Training, Meditation and Mind-Body Connection. b) Teaching Meditation and Yoga Exercises inside and outside the Treatment Session and during the Day c) Removing Barriers to Successful Education, Providing Brochures Related to the Instructions of each Session that were given to the Clients and Daily Homework Exercises. Intervention 2: Control group: The control group does not receive any other treatment except its drug 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 not enough information at the moment</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Sarebannezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8, No. 3, Bilal Alley, Imam Ali St, Imam Ali Sq, Shahid Mahalati Town, Mini city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955746175</zip>
        <telephone>+98 21 2245 3511</telephone>
        <email>sareban24375@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Sarebannezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 8, No. 3, Bilal Alley, Imam Ali St, Imam Ali Sq, Shahid Mahalati Town, Mini city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1955746175</zip>
        <telephone>+98 21 2245 3511</telephone>
        <email>sareban24375@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Oral Lichen Planus Patients whose Disease has been Diagnosed through Biopsy and Histopathology Results.
Patients who are in the Symptomatic Phase of the Disease.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Absence of Pain and Burning or Mild Pain and Burning (Score Lower than 4 on the VAS).
Age younger than 18 and older than 60
Degree less than middle School degree</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Lichen planus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness Based Stress Reduction was created by Kabat-Zinn (1990), This Treatment is an Eight Week Evidence based Program. The Main Contents of the Treatment are: a) Relaxation Training, Meditation and Mind-Body Connection. b) Teaching Meditation and Yoga Exercises inside and outside the Treatment Session and during the Day c) Removing Barriers to Successful Education, Providing Brochures Related to the Instructions of each Session that were given to the Clients and Daily Homework Exercises</i_keyword>
      <i_keyword>Control group: The control group does not receive any other treatment except its drug treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological Disturbance Score in DASS-21. Timepoint: Before the Intervention, After the Intervention. Method of measurement: DASS-21.</prim_outcome>
      <prim_outcome>Pain Catastrophizing. Timepoint: Before the Intervention, After the Intervention. Method of measurement: Pain Catastrophizing Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Severity of Pain and Burning. Timepoint: Before the Intervention, After the Intervention. Method of measurement: Visual Analouge Scale.</sec_outcome>
      <sec_outcome>Shape and Size of the Lesions. Timepoint: Before the Intervention, After the Intervention. Method of measurement: Thongprasom Scale.</sec_outcome>
      <sec_outcome>Quality of Life Related to Oral Health. Timepoint: Before the Intervention, After the Intervention. Method of measurement: Oral Health Impact Profile-14 (OHIP-14).</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-23</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>5th kilometer of Qutb Rawandi Blvd., Kashan University of Medical Sciences Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
