<?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>IRCT20181206041867N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-28</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the Impact of Mindfulness-Based Cognitive Therapy on Burns</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the Impact of Mindfulness-Based Cognitive Therapy on the Quality of Life of Burn Survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73566</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, samples are selected by the convenience sampling method, then randomly by the lottery method, 30 people are allocated to the control group and 30 people to the intervention group. So we put the names of all the people on paper and in a box, and then we take the papers out individually (without replacing them) until the sample size of the intervention group is completed, and the rest of the names left in the box are in the control group, Blinding description: Given that the knowledge that the participants were in the intervention or control group could affect the results of the study, the study groups were blinded. So after the first session provides explanations about the purpose of the study and other points and informed consent, in the next step, the participant does not know whether he is in the intervention or control group, but to solve the moral problem of the work, the training package is also provided to the control group at the end of the study to benefit from its benefits. Also, given that the data analyzer also knows about groups, it may affect the analysis and results, the data analyzer will also be blinded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Quality of life of burn patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: intervention (mindfulness-based cognitive therapy training) will be held within 8 two-hour sessions for the intervention group. This approach increases the flexibility of cognitive activities and reduces intellectual rumination, hypertonicity, and self-critical assessments, and increases cognitive processes such as non-judgmental observation of mental content. Mindfulness-based cognitive therapy training will be conducted in groups ( three groups of 10 people) and between 10 and 12 a.m. on Thursdays, based on the Kabatzin Mindfulness-Based Cognitive Therapy Program. Session one: introduction of the program (explanation of Sessions and objectives), automatic guidance, training and practice of breathing and eating twin with conscious attention, presentation of assignments; session two: review of completed assignments, explanations related to mechanisms and reactions, description of the results of some recent research on the effectiveness of MBCT, sitting meditation (breathing, listening to sound, paying attention to thoughts and feelings in a sitting position), breathing practice and walking twin with conscious attention, presentation of assignments; session three: review of completed assignments training in body scanning techniques, training in conscious attention, training in stop techniques, one-minute breathing space, presenting assignments, session four.: Review of completed assignments, the practice of yoga movements and exercises, the practice of body scanning and yoga meditation, presentation of assignments; session five: a review of completed assignments, explain the importance of thoughts in the manifestation of emotions, the practice of sitting yoga meditation, presentation of assignments; session six: a review of completed assignments, training, and practice of pond and Mountain meditation, presentation of assignments; session seven: review of completed assignments, training and practice of compassion meditation, presentation of assignments; session eight: Reviewing assignments, receiving feedback from Group members on the principles taught, summarizing past content, using conscious attention techniques (conscious attention walking, conscious attention eating, and so on)...) In life and its generalization to the whole flow of life. Intervention 2: Control group: no intervention will be done on the control group and they will only receive routine treatments. At the end of the study, the training given to the intervention group will be given to the control group in the form of a booklet.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Demographic data and main outcome results of the study can be shared after de-identifying people

When:
The access period starts 6 months after the results are published

To whom:
Available for researchers working in scientific and academic institutions

Conditions:
Further statistical analysis

Where to obtain:
Fariba Hossein Zadegan, Assistant Professor, Urmia University of Medical Sciences, Faculty of Nursing and Midwifery
mail:hosseinzadegan.f@umsu.ac.ir
tell:09144710551

How to obtain:
Submission of request, check by recipient, sending response

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariba Hosseinzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Nazlou Campus, Urmia University of Medical Sciences, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15335-57561</zip>
        <telephone>+98 44 3275 4918</telephone>
        <email>Hosseinzadegan.f@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariba Hosseinzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery, Nazlou Campus, Urmia University of Medical Sciences, Urmia, Iran</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15335-57561</zip>
        <telephone>+98 44 3275 4918</telephone>
        <email>Hosseinzadegan.f@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are between the age group of 18-45 years.
Patients Suffering from second-degree burns.
Having a burn level between 15-45%.
It has been at least six months since the burn.
Having at least a high school diploma.
Having the willingness to participate in the study.
Having the ability to speak Persian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Confirmed mental illness and self-immolation
Having burns in the face, neck, and genital areas</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Burn and corrosion of trunk</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: intervention (mindfulness-based cognitive therapy training) will be held within 8 two-hour sessions for the intervention group. This approach increases the flexibility of cognitive activities and reduces intellectual rumination, hypertonicity, and self-critical assessments, and increases cognitive processes such as non-judgmental observation of mental content. Mindfulness-based cognitive therapy training will be conducted in groups ( three groups of 10 people) and between 10 and 12 a.m. on Thursdays, based on the Kabatzin Mindfulness-Based Cognitive Therapy Program. Session one: introduction of the program (explanation of Sessions and objectives), automatic guidance, training and practice of breathing and eating twin with conscious attention, presentation of assignments; session two: review of completed assignments, explanations related to mechanisms and reactions, description of the results of some recent research on the effectiveness of MBCT, sitting meditation (breathing, listening to sound, paying attention to thoughts and feelings in a sitting position), breathing practice and walking twin with conscious attention, presentation of assignments; session three: review of completed assignments training in body scanning techniques, training in conscious attention, training in stop techniques, one-minute breathing space, presenting assignments, session four.: Review of completed assignments, the practice of yoga movements and exercises, the practice of body scanning and yoga meditation, presentation of assignments; session five: a review of completed assignments, explain the importance of thoughts in the manifestation of emotions, the practice of sitting yoga meditation, presentation of assignments; session six: a review of completed assignments, training, and practice of pond and Mountain meditation, presentation of assignments; session seven: review of completed assignments, training and practice of compassion meditation, presentation of assignments; session eight: Reviewing assignments, receiving feedback from Group members on the principles taught, summarizing past content, using conscious attention techniques (conscious attention walking, conscious attention eating, and so on)...) In life and its generalization to the whole flow of life.</i_keyword>
      <i_keyword>Control group: no intervention will be done on the control group and they will only receive routine treatments. At the end of the study, the training given to the intervention group will be given to the control group in the form of a booklet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Improving the quality of life. Timepoint: The quality of life assessment will be conducted at the beginning of the study (pre-intervention), after intervention and 30 days after intervention. Method of measurement: The Burn Specific Health Brief Scale (BSHBS).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-11</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Orjhans Street, Resalat Blvd, Urmia , Iran Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
