Idiopathic ScoliosisNCT05059561
Temperament and Character Traits in Young Men With Idiopathic Scoliosis
An observational study of Idiopathic Scoliosis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- X-ray radiograghy
- Type of treatment
- Surgery or procedure
- How many people
- 324 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 Jul 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Patient group: 162 person Control group: 162 person
Who may be able to join
- Inclusion criteria were 18 years of age and older, adequate level of education (at least primary school graduates) and capable of taking the tests and structured interview form, agreed to participate in the study, diagnosed with IS and did not have any psychiatric follow-up and treatment history.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Üsküdar, Istanbul, 34668
About this study
Official title: Temperament and Character Traits in Young Men Diagnosed With Idiopathic Scoliosis
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.
Read the detailed description
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. In the same period, 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 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.
- Conditions
- Idiopathic Scoliosis
- Being tested
- X-ray radiograghy
- Keywords
- Idiopathic scoliosis, temperament, character, personality, persistence, novelty-seeking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray radiograghyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: X-ray radiograghy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: July 2017-July 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Jul 2017
- Primary completion1 Dec 2017
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 324 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozgur Maden, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059561
- Sponsor's protocol ID
- Sultan Abdulhamid TRH
- Status last verified
- Sep 2021
- First submitted
- 19 Sep 2021
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
Lundberg G, Anderberg UM, Gerdle B. Personality features in female fibromyalgia syndrome. J Musculosketal Pain, 2009;17: 117-130.
Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
PubMed 10842426Cloninger 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.
PubMed 8250684Cloninger CR. Temperament and personality. Curr Opin Neurobiol. 1994 Apr;4(2):266-73. doi: 10.1016/0959-4388(94)90083-3.
PubMed 8038587Cobb JR. Outline for the study of scoliosis. American Academy of Orthopaedic Surgeons Instructional Course Lectures, 1948;5: 261-265.
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.
PubMed 29399224Fisher S, Cleveland SE. Body image and personality. Princeton, NJ: Nostrand, 1958.
Freidel K. Psychosocial problems in idiopathic scoliosis. Retrieved from: Berlin: dissertation.de, 1999.
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.
PubMed 24549924Grauers 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.
PubMed 27933320Grucza 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.
PubMed 17292702Hresko 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.
PubMed 27535448Kasai 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.
PubMed 12851787Konieczny 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.
PubMed 24432052
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperament and Character Traits in Young Men Diagnosed With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05059561
- Acronym / sponsor ID
- Sultan Abdulhamid TRH
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, temperament, character, personality, persistence, novelty-seeking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. In the same period, 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Radiation: X-ray radiograghyAll 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. |
| Control group | – | Radiation: X-ray radiograghyAll 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient group: 162 person Control group: 162 person
Key inclusion criteria (1 listed)
- Inclusion criteria were 18 years of age and older, adequate level of education (at least primary school graduates) and capable of taking the tests and structured interview form, agreed to participate in the study, diagnosed with IS and did not have any psychiatric follow-up and treatment history.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-ray radiograghyCobb 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. | Radiation | Control group, Patients group |
Primary outcome
Temperament and Character Traits in Young Men Diagnosed With Idiopathic Scoliosis - First Evaluation
Time frame: July 2017-July 2018
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- BackgroundKuloğlu 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.
- BackgroundLundberg G, Anderberg UM, Gerdle B. Personality features in female fibromyalgia syndrome. J Musculosketal Pain, 2009;17: 117-130.
- Results publication: PubMed 10842426Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
- Results publication: PubMed 8250684Cloninger 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.
- Results publication: PubMed 8038587Cloninger CR. Temperament and personality. Curr Opin Neurobiol. 1994 Apr;4(2):266-73. doi: 10.1016/0959-4388(94)90083-3.
- Results publicationCobb JR. Outline for the study of scoliosis. American Academy of Orthopaedic Surgeons Instructional Course Lectures, 1948;5: 261-265.
- Results publication: PubMed 29399224Fadzan 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.
- Results publicationFisher S, Cleveland SE. Body image and personality. Princeton, NJ: Nostrand, 1958.
- Results publicationFreidel K. Psychosocial problems in idiopathic scoliosis. Retrieved from: Berlin: dissertation.de, 1999.
- Results publication: PubMed 24549924Gokmen 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.
- Results publication: PubMed 27933320Grauers 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.
- Results publication: PubMed 17292702Grucza 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperament and Character Traits in Young Men Diagnosed With Idiopathic Scoliosis - First Evaluation (time frame: July 2017-July 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059561, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.