xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009601</url>
    </required_header>
    <id_info>
      <org_study_id>397</org_study_id>
      <nct_id>NCT06009601</nct_id>
    </id_info>
    <brief_title>The Relationship Between Pectus Deformities and Spinal Pathologies</brief_title>
    <official_title>Are Pectus Deformities a Projection of Spinal Pathologies?The Relationship Between Pectus Deformities and Spinal Pathologies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaziosmanpasa Research and Education Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gaziosmanpasa Research and Education Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Pectus deformities are common anterior chest wall pathologies. Pectus excavatum is the most&#xD;
        common chest deformity with an incidence of 0.1-0.3%. Although the incidence of adolescent&#xD;
        idiopathic scoliosis (AIS) is 0.2-3% in the community, some studies show that this rate rises&#xD;
        to 17.61-25.58% when it is associated with pectus deformity. While the pectus excavatum&#xD;
        rotates the heart to the left with its ribs and cartilages, it pushes the thoracic vertebra&#xD;
        to the right side with the internal counterforce created by the heart, which has been shown&#xD;
        to push the spine to the right with an asymmetric horizontal force in scoliosis patients with&#xD;
        pectus deformity.&#xD;
  &#xD;
        Based on this, in study, investigators aimed to determine whether there is any relationship&#xD;
        between pectus deformities and spinal pathologies, and if there is a relationship, with which&#xD;
        pathology it is most common, whether the type of scoliosis seen in pectus deformities with a&#xD;
        prominent scoliosis prevalence is a pectus-specific curve, and whether this curve seen in&#xD;
        scoliosis is associated with pectus. To determine whether there is a footprint or not.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was planned as a prospective cross-sectional study. Pectus study forms consisting&#xD;
        of clinical and radiological measurements of the patients aged 3-18 years who applied to the&#xD;
        outpatient clinic with chest deformity will be filled in in detail, and the Adams test&#xD;
        (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment&#xD;
        tool) and ATR (angle of trunk rotation- trunk rotation) measurements. If ATR measurement is&#xD;
        above 7 degrees on Bunnell scoliometer, patients who meet the inclusion criteria will be&#xD;
        included in the study by filling in the informed consent form and a scoliosis radiograph will&#xD;
        be requested (Independent of investigators' study, it is necessary to withdraw it in line&#xD;
        with the 2016 recommendations of the International Scientific Society for Scoliosis&#xD;
        Orthopedic and Rehabilitation Treatment (SOSORT).)&#xD;
  &#xD;
        Coronal, sagittal balance, coronal and sagittal cobb angles will be measured from the&#xD;
        scoliosis radiograph taken from the Posterior-Anterior (PA) (posterior-anterior) and lateral&#xD;
        (side) films. Their relationship with chest deformities will be evaluated. All measurements&#xD;
        will be made and recorded by two independent investigators As a result of the analysis, when&#xD;
        the power is targeted as 95% and the error amount as 0.05, the minimum sample size required&#xD;
        for investigators to find a significant difference between the means was determined as 36.&#xD;
        Investigators formed a sample group of 40 people for our study, together with the fact that&#xD;
        groups of 36 people were sufficient in terms of providing 95% power. Kappa statistical&#xD;
        analysis will be used to determine intraobserver and interobserver variations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 9, 2023</start_date>
    <completion_date type="Actual">April 28, 2023</completion_date>
    <primary_completion_date type="Actual">April 9, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Pectus Study Form</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>In the Pectus Study Form, the clinical and radiological data of the patient will be evaluated. Coronal, sagittal balance and coronal and sagittal cobb angles of the patient will be measured in the scoliosis X-ray.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pulmonary Function Test (PFT)</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>Pulmonary function test measurements will be made for people with pectus deformity.Pulmonary function tests, or PFTs, measure how well the lungs work. For some of the test measurements, the client can breathe normally and quietly. Other tests require forced inhalation or exhalation after a deep breath. Sometimes, they will be asked to inhale a different gas or a medicine to see how it changes test results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body Aesthetic Clinical Evaluation (TRACE)</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>Body Aesthetic Clinical Evaluation (TRACE) measurement will be performed.TRACE is a 12-point scale based on four sub-scales, shoulders (0-3), scapulae (0-2), hemi-thorax (0-2) and waist (0-4)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Evaluation Form in Pectus Deformity</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>This questionnaire, a self-assessment one, will assist clinicians who wish to assess body image and quality of life of patients with Pectus deformity. The PEEQ is a questionnaire used to assess the disease-speciﬁc quality of life of patients with PE and their parents. The questionnaire contains 12 items and the parent form contains 13 items. Each item receives a score between 1 and 4, with higher scores indicating a better quality of life. The questionnaire has subscales that indicate psychosocial and physical quality of life for both children and parents. The questions from 1 to 9 in the child form ask about psycho-social quality of life, while the questions 10-12 ask about physical quality of life. In the parents form, the questions from 1 to 8 ask about psychosocial quality of life, while the questions from 9 to13 ask about physical quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Comparison Scale</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing. This scale uses a semantic differential methodology and consists of 11 bipolar constructs. Participants are required to make a global comparison of themselves in relation to other people and to rate themselves along a ten-point scale. For example' the scale asks:&#xD;
  In relationship to others I feel: Incompetent -&gt;1 2 3 4 5 6 7 8 9 10 &lt;- More competent The 11-items cover judgments concerned with rank' attractiveness and how well the person thinks they 'fit in' with others in society. Low scores point to feelings of inferiority and general low rank self-perceptions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Disorder Scale for Children</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>Sleep Disorder Scale for Children (SDSC) was designed both to evaluate specific sleep disorders in children, and to provide an overall measure of sleep disturbance suitable for use in clinical screening and research. Using factor analysis, developers Bruni and colleagues divided items into six categories representing some of the most common sleep diffi culties affecting adolescents and children: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal/nightmares, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhidrosis (nighttime sweating).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety Disorders Screening Scale in Children</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>Anxiety Disorders Screening Scale in Children (SCARED) is a child self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. The SCARED consists of 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders.The Screen for Child Anxiety Related Emotional Disorders (SCARED) assesses a range of DSM-IV based anxiety symptomatology. More specifically, it taps symptoms of panic disorder (13 items), generalised anxiety disorder (9 items), social phobia (9 items), separation anxiety disorder (12 items), obsessive-compulsive disorder (9 items), post-traumatic stress disorder (4 items), and specific phobia (15 items). The SCARED-71 consists of 71 items rated on a three-point scale (0 = almost never, 1 = sometimes, 2 = often). The minimum score that could be obtained is 0 and the maximum score that could be obtained is 142.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Pediatric Quality of Life Inventory</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scoliosis Research Society Score</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Anxiety Scale</measure>
      <time_frame>Within 1 week of applying to the scoliosis outpatient clinic</time_frame>
      <description>The Beck Anxiety Inventory (BAI), created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adolescents and adults ages 17 and older.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are:0-7: Minimal, 8-15: Mild, 16-25: Moderate,and 26-63: Severe</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">40</enrollment>
    <condition>Pectus Deformity of Chest</condition>
    <condition>Spinal Deformity</condition>
    <arm_group>
      <arm_group_label>Patients aged 3-18 years who were diagnosed with pectus deformity</arm_group_label>
      <description>Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pectus Study Form</intervention_name>
      <description>Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.&#xD;
  In addition, this study form includes 'Quality of Life Evaluation Form in Pectus Deformity', 'Social Comparison Scale', 'Sleep Disorder Scale for Children', 'Anxiety Disorders Screening Scale in Children', 'Pediatric Quality of Life Questionnaire' designed for patients and their relatives. PedsQL)', 'SRS-22 Patient Questionnaire', 'Beck Anxiety Scale' and 'Informed Consent Form' designed for patients and their relatives.</description>
      <arm_group_label>Patients aged 3-18 years who were diagnosed with pectus deformity</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Adams Test</intervention_name>
      <description>Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 7 degrees in patients who meet the inclusion criteria will be included in the study by filling out an informed consent form</description>
      <arm_group_label>Patients aged 3-18 years who were diagnosed with pectus deformity</arm_group_label>
      <other_name>Forward Bending Test</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Scoliosis Graphy</intervention_name>
      <description>ATR (angle of trunk rotation) values above 7 degrees on bunnell scoliometer were determined. Afterwards, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis graphy will be requested.&#xD;
  Coronal, sagittal balance; coronal and sagittal cobb angles will be measured from posterior-anterior (PA) (posterior-anterior) and lateral (lateral) scoliosis radiographs.</description>
      <arm_group_label>Patients aged 3-18 years who were diagnosed with pectus deformity</arm_group_label>
      <other_name>Orthoroentgenogram</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pulmonary function test</intervention_name>
      <description>Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.&#xD;
  There are 2 types of disorders that cause problems with air moving in and out of the lungs:&#xD;
  Obstructive. This is when air has trouble flowing out of the lungs due to airway resistance. This causes a decreased flow of air.&#xD;
  Restrictive. This is when the lung tissue and/or chest muscles can't expand enough. This creates problems with air flow, mostly due to lower lung volumes.</description>
      <arm_group_label>Patients aged 3-18 years who were diagnosed with pectus deformity</arm_group_label>
      <other_name>Spirometry Function Test</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pectus study forms consisting of clinical and radiological measurements of patients aged&#xD;
          3-18 years who applied to the outpatient clinic with chest deformity will be filled in in&#xD;
          detail. Adams test (forward bending test) (+) was measured by Bunnell scoliometer&#xD;
          (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 5 degrees&#xD;
          in those with BMI (Body Mass Index) above 85%. If it is below 85% and above 7 degrees,&#xD;
          patients who meet the inclusion criteria will be included in the study by filling out an&#xD;
          informed consent form and a scoliosis film will be requested. Scoliosis X-ray&#xD;
          (orthorontgenogram) will be requested. Coronal, sagittal balance, coronal and sagittal cobb&#xD;
          angles will be measured. Their relationship with chest deformities will be evaluated. All&#xD;
          measurements will be made and recorded by two independent researchers.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with pectus deformity&#xD;
  &#xD;
            -  Be between 3-18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Adult type scoliosis&#xD;
  &#xD;
            -  Congenital scoliosis&#xD;
  &#xD;
            -  Neuromuscular scoliosis&#xD;
  &#xD;
            -  Syndromic scoliosis&#xD;
  &#xD;
            -  Infantile idiopathic scoliosis&#xD;
  &#xD;
            -  Having surgery to the chest wall or spine&#xD;
  &#xD;
            -  People with connective tissue disease will not be included in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Meryem Guneser Gulec, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ebru Yilmaz Yalcinkaya, Prof</last_name>
      <role>Study Director</role>
      <affiliation>Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Deniz</name>
        <address>
          <city>Gazi̇osmanpaşa</city>
          <state>İstanbul</state>
          <zip>34255</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Zhong W, Ye J, Feng J, Geng L, Lu G, Liu J, Zhang C. Effects of Pectus Excavatum on the Spine of Pectus Excavatum Patients with Scoliosis. J Healthc Eng. 2017;2017:5048625. doi: 10.1155/2017/5048625. Epub 2017 Jul 3.</citation>
      <PMID>29065615</PMID>
    </results_reference>
    <results_reference>
      <citation>Tomaszewski R, Wiktor L, Machala L. Evaluation of thoracic vertebrae rotation in patients with pectus excavatum. Acta Orthop Traumatol Turc. 2017 Jul;51(4):284-289. doi: 10.1016/j.aott.2017.03.005. Epub 2017 Jun 16.</citation>
      <PMID>28624480</PMID>
    </results_reference>
    <results_reference>
      <citation>Tauchi R, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A. Evaluation of thoracic factors after scoliosis surgery in patients with both scoliosis and pectus excavatum. Eur Spine J. 2018 Feb;27(2):381-387. doi: 10.1007/s00586-016-4753-4. Epub 2016 Aug 27.</citation>
      <PMID>27568387</PMID>
    </results_reference>
    <results_reference>
      <citation>Alaca N, Yuksel M. Comparison of physical functions and psychosocial conditions between adolescents with pectus excavatum, pectus carinatum and healthy controls. Pediatr Surg Int. 2021 Jun;37(6):765-775. doi: 10.1007/s00383-021-04857-7. Epub 2021 Jan 16.</citation>
      <PMID>33454849</PMID>
    </results_reference>
    <results_reference>
      <citation>Iscan M, Kilic B, Turna A, Kaynak MK. The effect of minimally invasive pectus excavatum repair on thoracic scoliosis. Eur J Cardiothorac Surg. 2020 Oct 30:ezaa328. doi: 10.1093/ejcts/ezaa328. Online ahead of print.</citation>
      <PMID>33123728</PMID>
    </results_reference>
    <results_reference>
      <citation>Tauchi R, Suzuki Y, Tsuji T, Ohara T, Saito T, Nohara A, Morishita K, Yamauchi I, Kawakami N. Clinical Characteristics and Thoracic factors in patients with Idiopathic and Syndromic Scoliosis Associated with Pectus Excavatum. Spine Surg Relat Res. 2018 Jan 27;2(1):37-41. doi: 10.22603/ssrr.2017-0027. eCollection 2018.</citation>
      <PMID>31440644</PMID>
    </results_reference>
    <results_reference>
      <citation>van Es LJM, van Royen BJ, Oomen MWN. Clinical significance of concomitant pectus deformity and adolescent idiopathic scoliosis: systematic review with best evidence synthesis. N Am Spine Soc J. 2022 Jun 25;11:100140. doi: 10.1016/j.xnsj.2022.100140. eCollection 2022 Sep.</citation>
      <PMID>35814492</PMID>
    </results_reference>
    <results_reference>
      <citation>Alaca N, Cagri Aslan D, Alaca I, Yuksel M. The psychometric properties of the Turkish version of the pectus carinatum body image quality of life questionnaire. Pediatr Surg Int. 2022 Jun;38(6):833-842. doi: 10.1007/s00383-022-05119-w. Epub 2022 Apr 7.</citation>
      <PMID>35389073</PMID>
    </results_reference>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>January 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pectus Excavatum</keyword>
    <keyword>Pectus Carinatum</keyword>
    <keyword>Scoliosis</keyword>
    <keyword>Kyphosis</keyword>
    <keyword>Lordosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Congenital Abnormalities</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009601
  org study id: 397
  nct id: NCT06009601
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pectus deformities are common anterior chest wall pathologies. Pectus excavatum is the most
        common chest deformity with an incidence of 0.1-0.3%. Although the incidence of adolescent
        idiopathic scoliosis (AIS) is 0.2-3% in the community, some studies show that this rate rises
        to 17.61-25.58% when it is associated with pectus deformity. While the pectus excavatum
        rotates the heart to the left with its ribs and cartilages, it pushes the thoracic vertebra
        to the right side with the internal counterforce created by the heart, which has been shown
        to push the spine to the right with an asymmetric horizontal force in scoliosis patients with
        pectus deformity.
  
        Based on this, in study, investigators aimed to determine whether there is any relationship
        between pectus deformities and spinal pathologies, and if there is a relationship, with which
        pathology it is most common, whether the type of scoliosis seen in pectus deformities with a
        prominent scoliosis prevalence is a pectus-specific curve, and whether this curve seen in
        scoliosis is associated with pectus. To determine whether there is a footprint or not.
  The study was planned as a prospective cross-sectional study. Pectus study forms consisting
        of clinical and radiological measurements of the patients aged 3-18 years who applied to the
        outpatient clinic with chest deformity will be filled in in detail, and the Adams test
        (forward bending test) (+) will be measured by Bunnell scoliometer (scoliosis assessment
        tool) and ATR (angle of trunk rotation- trunk rotation) measurements. If ATR measurement is
        above 7 degrees on Bunnell scoliometer, patients who meet the inclusion criteria will be
        included in the study by filling in the informed consent form and a scoliosis radiograph will
        be requested (Independent of investigators' study, it is necessary to withdraw it in line
        with the 2016 recommendations of the International Scientific Society for Scoliosis
        Orthopedic and Rehabilitation Treatment (SOSORT).)
  
        Coronal, sagittal balance, coronal and sagittal cobb angles will be measured from the
        scoliosis radiograph taken from the Posterior-Anterior (PA) (posterior-anterior) and lateral
        (side) films. Their relationship with chest deformities will be evaluated. All measurements
        will be made and recorded by two independent investigators As a result of the analysis, when
        the power is targeted as 95% and the error amount as 0.05, the minimum sample size required
        for investigators to find a significant difference between the means was determined as 36.
        Investigators formed a sample group of 40 people for our study, together with the fact that
        groups of 36 people were sufficient in terms of providing 95% power. Kappa statistical
        analysis will be used to determine intraobserver and interobserver variations.
  observational model: Other
  time perspective: Prospective
  measure: Pectus Study Form
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: In the Pectus Study Form, the clinical and radiological data of the patient will be evaluated. Coronal, sagittal balance and coronal and sagittal cobb angles of the patient will be measured in the scoliosis X-ray.
  measure: Pulmonary Function Test (PFT)
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: Pulmonary function test measurements will be made for people with pectus deformity.Pulmonary function tests, or PFTs, measure how well the lungs work. For some of the test measurements, the client can breathe normally and quietly. Other tests require forced inhalation or exhalation after a deep breath. Sometimes, they will be asked to inhale a different gas or a medicine to see how it changes test results.
  measure: Body Aesthetic Clinical Evaluation (TRACE)
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: Body Aesthetic Clinical Evaluation (TRACE) measurement will be performed.TRACE is a 12-point scale based on four sub-scales, shoulders (0-3), scapulae (0-2), hemi-thorax (0-2) and waist (0-4)
  measure: Quality of Life Evaluation Form in Pectus Deformity
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: This questionnaire, a self-assessment one, will assist clinicians who wish to assess body image and quality of life of patients with Pectus deformity. The PEEQ is a questionnaire used to assess the disease-speciﬁc quality of life of patients with PE and their parents. The questionnaire contains 12 items and the parent form contains 13 items. Each item receives a score between 1 and 4, with higher scores indicating a better quality of life. The questionnaire has subscales that indicate psychosocial and physical quality of life for both children and parents. The questions from 1 to 9 in the child form ask about psycho-social quality of life, while the questions 10-12 ask about physical quality of life. In the parents form, the questions from 1 to 8 ask about psychosocial quality of life, while the questions from 9 to13 ask about physical quality of life.
  measure: Social Comparison Scale
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing. This scale uses a semantic differential methodology and consists of 11 bipolar constructs. Participants are required to make a global comparison of themselves in relation to other people and to rate themselves along a ten-point scale. For example' the scale asks:
  In relationship to others I feel: Incompetent ->1 2 3 4 5 6 7 8 9 10 <- More competent The 11-items cover judgments concerned with rank' attractiveness and how well the person thinks they 'fit in' with others in society. Low scores point to feelings of inferiority and general low rank self-perceptions.
  measure: Sleep Disorder Scale for Children
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: Sleep Disorder Scale for Children (SDSC) was designed both to evaluate specific sleep disorders in children, and to provide an overall measure of sleep disturbance suitable for use in clinical screening and research. Using factor analysis, developers Bruni and colleagues divided items into six categories representing some of the most common sleep diffi culties affecting adolescents and children: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal/nightmares, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhidrosis (nighttime sweating).
  measure: Anxiety Disorders Screening Scale in Children
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: Anxiety Disorders Screening Scale in Children (SCARED) is a child self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia. The SCARED consists of 41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders.The Screen for Child Anxiety Related Emotional Disorders (SCARED) assesses a range of DSM-IV based anxiety symptomatology. More specifically, it taps symptoms of panic disorder (13 items), generalised anxiety disorder (9 items), social phobia (9 items), separation anxiety disorder (12 items), obsessive-compulsive disorder (9 items), post-traumatic stress disorder (4 items), and specific phobia (15 items). The SCARED-71 consists of 71 items rated on a three-point scale (0 = almost never, 1 = sometimes, 2 = often). The minimum score that could be obtained is 0 and the maximum score that could be obtained is 142.
  measure: The Pediatric Quality of Life Inventory
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: The Pediatric Quality of Life Inventory (PedsQL) is a 23-item generic health status instrument with parent and child forms that assesses five domains of health (physical functioning, emotional functioning, psychosocial functioning, social functioning, and school functioning) in children and adolescents ages 2 to 18. Each item of the instrument is scored on a 5-point scale from 0- 4 for ages 8-18, (0 = never a problem, 1 = almost never a problem, 2 = sometimes a problem, 3 = often a problem, 4 = almost always a problem) ad 3-point scale for young child self reporting (ages 5- 7) as following (0 = not at all a problem, 2 = sometimes a problem, 4 = a lot of a problem) the large score means worst symptoms , scores are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0) in which high score means better condition
  measure: Scoliosis Research Society Score
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: The SRS-22r is a validated questionnaire intended to assess outcomes in patients with idiopathic scoliosis after spinal surgery. The first version, developed by the Scoliosis Research Society in 1999, had 24 items, and this was reduced to 22 items (accompanied by a name change) in the course of 3 major updates.The SRS-22 contains 22 questions covering 5 domains: function/activity 5 items; pain 5 items; self-perceived image 5 items; mental health 5 items; and satisfaction with treatment 2 items. Each item is scored from 1 (worst) to 5 (best). Each domain has a total sum score ranging from 5 to 25, except for satisfaction, which ranges from 2 to 10. The sum of the first 4 domains gives a maximum subtotal of 100, and when the satisfaction domain is included, the maximum total is 110
  measure: Beck Anxiety Scale
  time frame: Within 1 week of applying to the scoliosis outpatient clinic
  description: The Beck Anxiety Inventory (BAI), created by Aaron T. Beck and other colleagues, is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adolescents and adults ages 17 and older.The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The standardized cutoffs are:0-7: Minimal, 8-15: Mild, 16-25: Moderate,and 26-63: Severe
  arm group label: Patients aged 3-18 years who were diagnosed with pectus deformity
  description: Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
  intervention type: Diagnostic Test
  intervention name: Pectus Study Form
  description: Pectus study forms consisting of clinical and radiological measurements of patients aged 3-18 years who applied to the outpatient clinic with chest deformity will be filled in in detail.
  In addition, this study form includes 'Quality of Life Evaluation Form in Pectus Deformity', 'Social Comparison Scale', 'Sleep Disorder Scale for Children', 'Anxiety Disorders Screening Scale in Children', 'Pediatric Quality of Life Questionnaire' designed for patients and their relatives. PedsQL)', 'SRS-22 Patient Questionnaire', 'Beck Anxiety Scale' and 'Informed Consent Form' designed for patients and their relatives.
  arm group label: Patients aged 3-18 years who were diagnosed with pectus deformity
  intervention type: Diagnostic Test
  intervention name: Adams Test
  description: Adams test (forward bending test) (+) was measured by Bunnell scoliometer (scoliosis assessment tool) and ATR (angle of trunk rotation angle) values were 7 degrees in patients who meet the inclusion criteria will be included in the study by filling out an informed consent form
  arm group label: Patients aged 3-18 years who were diagnosed with pectus deformity
  other name: Forward Bending Test
  intervention type: Diagnostic Test
  intervention name: Scoliosis Graphy
  description: ATR (angle of trunk rotation) values above 7 degrees on bunnell scoliometer were determined. Afterwards, patients who meet the inclusion criteria will be included in the study by filling out an informed consent form and a scoliosis graphy will be requested.
  Coronal, sagittal balance; coronal and sagittal cobb angles will be measured from posterior-anterior (PA) (posterior-anterior) and lateral (lateral) scoliosis radiographs.
  arm group label: Patients aged 3-18 years who were diagnosed with pectus deformity
  other name: Orthoroentgenogram
  intervention type: Diagnostic Test
  intervention name: Pulmonary function test
  description: Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange. This information can help your healthcare provider diagnose and decide the treatment of certain lung disorders.
  There are 2 types of disorders that cause problems with air moving in and out of the lungs:
  Obstructive. This is when air has trouble flowing out of the lungs due to airway resistance. This causes a decreased flow of air.
  Restrictive. This is when the lung tissue and/or chest muscles can't expand enough. This creates problems with air flow, mostly due to lower lung volumes.
  arm group label: Patients aged 3-18 years who were diagnosed with pectus deformity
  other name: Spirometry Function Test
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Meryem Guneser Gulec, MD
  role: Study Chair
  affiliation: Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
  last name: Ebru Yilmaz Yalcinkaya, Prof
  role: Study Director
  affiliation: Gaziosmanpasa Training and Research Hospital Physical Rehabilitation Department
  facility: 
  country: Turkey
  citation: Zhong W, Ye J, Feng J, Geng L, Lu G, Liu J, Zhang C. Effects of Pectus Excavatum on the Spine of Pectus Excavatum Patients with Scoliosis. J Healthc Eng. 2017;2017:5048625. doi: 10.1155/2017/5048625. Epub 2017 Jul 3.
  PMID: 29065615
  citation: Tomaszewski R, Wiktor L, Machala L. Evaluation of thoracic vertebrae rotation in patients with pectus excavatum. Acta Orthop Traumatol Turc. 2017 Jul;51(4):284-289. doi: 10.1016/j.aott.2017.03.005. Epub 2017 Jun 16.
  PMID: 28624480
  citation: Tauchi R, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A. Evaluation of thoracic factors after scoliosis surgery in patients with both scoliosis and pectus excavatum. Eur Spine J. 2018 Feb;27(2):381-387. doi: 10.1007/s00586-016-4753-4. Epub 2016 Aug 27.
  PMID: 27568387
  citation: Alaca N, Yuksel M. Comparison of physical functions and psychosocial conditions between adolescents with pectus excavatum, pectus carinatum and healthy controls. Pediatr Surg Int. 2021 Jun;37(6):765-775. doi: 10.1007/s00383-021-04857-7. Epub 2021 Jan 16.
  PMID: 33454849
  citation: Iscan M, Kilic B, Turna A, Kaynak MK. The effect of minimally invasive pectus excavatum repair on thoracic scoliosis. Eur J Cardiothorac Surg. 2020 Oct 30:ezaa328. doi: 10.1093/ejcts/ezaa328. Online ahead of print.
  PMID: 33123728
  citation: Tauchi R, Suzuki Y, Tsuji T, Ohara T, Saito T, Nohara A, Morishita K, Yamauchi I, Kawakami N. Clinical Characteristics and Thoracic factors in patients with Idiopathic and Syndromic Scoliosis Associated with Pectus Excavatum. Spine Surg Relat Res. 2018 Jan 27;2(1):37-41. doi: 10.22603/ssrr.2017-0027. eCollection 2018.
  PMID: 31440644
  citation: van Es LJM, van Royen BJ, Oomen MWN. Clinical significance of concomitant pectus deformity and adolescent idiopathic scoliosis: systematic review with best evidence synthesis. N Am Spine Soc J. 2022 Jun 25;11:100140. doi: 10.1016/j.xnsj.2022.100140. eCollection 2022 Sep.
  PMID: 35814492
  citation: Alaca N, Cagri Aslan D, Alaca I, Yuksel M. The psychometric properties of the Turkish version of the pectus carinatum body image quality of life questionnaire. Pediatr Surg Int. 2022 Jun;38(6):833-842. doi: 10.1007/s00383-022-05119-w. Epub 2022 Apr 7.
  PMID: 35389073
  responsible party type: Sponsor
  mesh term: Congenital Abnormalities
  sharing ipd: No
  ipd description: The data that support the findings of this study will be available on request from the corresponding author (EG). The data will not be publicly available due to their containing information that could compromise the privacy of research participants.