NCT05059561

Brief Summary

This study was designed to investigate whether the temperament and character traits of young men with idiopathic scoliosis differ from healthy individuals of the same age group and characteristics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

September 19, 2021

Last Update Submit

September 19, 2021

Conditions

Keywords

Idiopathic scoliosistemperamentcharacterpersonalitypersistencenovelty-seeking

Outcome Measures

Primary Outcomes (1)

  • Temperament and Character Traits in Young Men Diagnosed With Idiopathic Scoliosis - First Evaluation

    Examining the X-ray radiograph results of all individuals who applied for a medical board examination report between July 2017 and July 2018, and identifying those with and without idiopathic scoliosis

    July 2017-July 2018

Study Arms (2)

Patients group

All patients who applied to the orthopedics and traumatology department between July 2017 and June 2018 for a medical board examination were evaluated by physical and radiological examination. According to the Cobb method, individuals with a Cobb angle greater than 10° were diagnosed with Idiopathic Scoliosis. All participants were evaluated by a senior psychiatrist. Before the interview, all subjects fully informed about the purpose and scope of the study. After their permission was obtained the study and control groups completed a socio-demographic data form consisting of questions about detailed personal and medical history and, the participants were asked to fill in the TCI.

Radiation: X-ray radiograghy

Control group

All patients who applied to the orthopedics and traumatology department between July 2017 and June 2018 for a medical board examination were evaluated by physical and radiological examination. Healthy individuals who applied for the same examination and met the inclusion criteria were determined as the control group by random sampling method. All participants were evaluated by a senior psychiatrist. Before the interview, all subjects fully informed about the purpose and scope of the study. After their permission was obtained the control group completed a socio-demographic data form consisting of questions about detailed personal and medical history and, the participants were asked to fill in the TCI.

Radiation: X-ray radiograghy

Interventions

Cobb angles of the patient and control groups were determined by using X-Ray radiography used in the radiological examination routinely applied to the individuals who applied for the health board examination.

Control groupPatients group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsYoung men over 18 years of age were included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient group: 162 person Control group: 162 person

You may not qualify if:

  • Individuals who were younger than 18 years of age, did not accept to participate in the study, had psychiatric disorders according to DSM V diagnostic criteria, additional medical disorders, and who were not at the level of education to take the tests and structured interview form were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Üsküdar, Istanbul, 34668, Turkey (Türkiye)

Location

Related Publications (29)

  • Kuloğlu M, Sağlam S, Korkmaz S et. al. Temperament and character traits and alexithymia in patients with multiple sclerosis. Archives of Neuropsychiatry, 2013;50(1):34-40.

    BACKGROUND
  • Lundberg G, Anderberg UM, Gerdle B. Personality features in female fibromyalgia syndrome. J Musculosketal Pain, 2009;17: 117-130.

    BACKGROUND
  • Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

  • Cloninger CR, Svrakic DM, Przybeck TR. A psychobiological model of temperament and character. Arch Gen Psychiatry. 1993 Dec;50(12):975-90. doi: 10.1001/archpsyc.1993.01820240059008.

  • Cloninger CR. Temperament and personality. Curr Opin Neurobiol. 1994 Apr;4(2):266-73. doi: 10.1016/0959-4388(94)90083-3.

  • Cobb JR. Outline for the study of scoliosis. American Academy of Orthopaedic Surgeons Instructional Course Lectures, 1948;5: 261-265.

    RESULT
  • Fadzan M, Bettany-Saltikov J. Etiological Theories of Adolescent Idiopathic Scoliosis: Past and Present. Open Orthop J. 2017 Dec 29;11:1466-1489. doi: 10.2174/1874325001711011466. eCollection 2017.

  • Fisher S, Cleveland SE. Body image and personality. Princeton, NJ: Nostrand, 1958.

    RESULT
  • Freidel K. Psychosocial problems in idiopathic scoliosis. Retrieved from: Berlin: dissertation.de, 1999.

    RESULT
  • Gokmen F, Altinbas K, Akbal A, Celik M, Savas Y, Gokmen E, Resorlu H, Karaca A. Evaluation of the temperament and character properties of patients with ankylosing spondylitis. Z Rheumatol. 2014 Nov;73(9):843-7. doi: 10.1007/s00393-013-1336-1.

  • Grauers A, Einarsdottir E, Gerdhem P. Genetics and pathogenesis of idiopathic scoliosis. Scoliosis Spinal Disord. 2016 Nov 28;11:45. doi: 10.1186/s13013-016-0105-8. eCollection 2016.

  • Grucza RA, Przybeck TR, Cloninger CR. Prevalence and correlates of binge eating disorder in a community sample. Compr Psychiatry. 2007 Mar-Apr;48(2):124-31. doi: 10.1016/j.comppsych.2006.08.002. Epub 2006 Nov 9.

  • Hresko MT, Talwalkar V, Schwend R; AAOS, SRS, and POSNA. Early Detection of Idiopathic Scoliosis in Adolescents. J Bone Joint Surg Am. 2016 Aug 17;98(16):e67. doi: 10.2106/JBJS.16.00224. No abstract available.

  • Kasai Y, Takegami K, Uchida A. A study of patients with spinal disease using Maudsley Personality Inventory. Int Orthop. 2004 Feb;28(1):56-9. doi: 10.1007/s00264-003-0489-y. Epub 2003 Jul 8.

  • Konieczny MR, Senyurt H, Krauspe R. Epidemiology of adolescent idiopathic scoliosis. J Child Orthop. 2013 Feb;7(1):3-9. doi: 10.1007/s11832-012-0457-4. Epub 2012 Dec 11.

  • Köse S, Sayar K, Ak İ et. al. Temperament and Character Inventory (Turkish TCI): Validity, reliability and factor structure. Bulletin of Clinical Psychopharmacology, 2004;14: 107-131.

    RESULT
  • Mancuso SG, Knoesen NP, Chamberlain JA et. al. The temperament and character profile of a body dysmorphic disorder outpatient sample. Personality and Mental Health, 2009;3(4): 284-294.

    RESULT
  • Misterska E, Glowacki M, Harasymczuk J. Personality characteristics of females with adolescent idiopathic scoliosis after brace or surgical treatment compared to healthy controls. Med Sci Monit. 2010 Dec;16(12):CR606-15.

  • Oh CH, Shim YS, Yoon SH, Park HC, Park CO, Lee MS. The psychopathological influence of adolescent idiopathic scoliosis in korean male : an analysis of multiphasic personal inventory test results. J Korean Neurosurg Soc. 2013 Jan;53(1):13-8. doi: 10.3340/jkns.2013.53.1.13. Epub 2013 Jan 31.

  • Özgüven İE. University students' problems and ways of coping. Hacettepe University Journal of Faculty of Education, 1992;7(7):5-13.

    RESULT
  • Pyatakova GV, Okoneshnikova OV, Kozhevnikova AO et. al. Psychological aspects of treatment and rehabilitation of patients with adolescent idiopathic scoliosis: Research analysis. Pediatric Traumatology, Orthopaedics and Reconstructive Surgery, 2019;7(2):103-115.

    RESULT
  • Saccomani L, Vercellino F, Rizzo P, Becchetti S. [Adolescents with scoliosis: psychological and psychopathological aspects]. Minerva Pediatr. 1998 Jan-Feb;50(1-2):9-14. Italian.

  • Schatzinger LH, Brower EM, Nash CL Jr. The patient with scoliosis. Spinal fusion: emotional stress and adjustment. Am J Nurs. 1979 Sep;79(9):1608-12. No abstract available.

  • Smith FM, Latchford G, Hall RM, Millner PA, Dickson RA. Indications of disordered eating behaviour in adolescent patients with idiopathic scoliosis. J Bone Joint Surg Br. 2002 Apr;84(3):392-4. doi: 10.1302/0301-620x.84b3.12619.

  • Sullivan S, Cloninger CR, Przybeck TR, Klein S. Personality characteristics in obesity and relationship with successful weight loss. Int J Obes (Lond). 2007 Apr;31(4):669-74. doi: 10.1038/sj.ijo.0803464. Epub 2006 Sep 5.

  • Weinstein SL, Dolan LA, Spratt KF, Peterson KK, Spoonamore MJ, Ponseti IV. Health and function of patients with untreated idiopathic scoliosis: a 50-year natural history study. JAMA. 2003 Feb 5;289(5):559-67. doi: 10.1001/jama.289.5.559.

  • Weinstein SL. The Natural History of Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S44-S46. doi: 10.1097/BPO.0000000000001350.

  • Weiss HR, Lehnert-Schroth C, Moramarco M. Schroth therapy: Advancements in conservative scoliosis treatment. Moldova, LAP Lambert Academic Publishing, 2018.

    RESULT
  • Yilmaz H, Zateri C, Kusvuran Ozkan A, Kayalar G, Berk H. Prevalence of adolescent idiopathic scoliosis in Turkey: an epidemiological study. Spine J. 2020 Jun;20(6):947-955. doi: 10.1016/j.spinee.2020.01.008. Epub 2020 Jan 20.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. MD.

Study Record Dates

First Submitted

September 19, 2021

First Posted

September 28, 2021

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

If requested, the study data can be accessed when deemed appropriate by the authors, provided that the identity information of the participants is kept confidential.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
There is no timeframe.

Locations