- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07481071
Cyberchondrie u adolescentů s idiopatickou skoliózou
Úroveň kyberchondrie a související faktory u pacientů s adolescentní idiopatickou skoliózou: studie případů a kontrol
Scoliosis is a three-dimensional torsional deformity of the spine and trunk characterized by alignment abnormalities in the coronal plane, the presence of axial rotation in the horizontal plane, and abnormalities in the normal spinal curves (lordosis-kyphosis) in the sagittal plane. The most common type of scoliosis, adolescent idiopathic scoliosis (AIS), has a prevalence of approximately 3%. AIS accounts for 85% of all scoliosis types. AIS is the name given to scoliosis diagnosed between the ages of 10 and 18. Because they are actively engaged with the internet, young people have begun researching health-related topics online due to the ease of access to such information. The internet has overshadowed traditional sources of health information, such as social circles, mass media (television, radio, newspapers, magazines, etc.), and medical and non-medical health professionals; searching for medical information online has become a popular activity. Searching for medical information online appears to offer various advantages in terms of anonymity, cost-effectiveness, potential for interaction, opportunities for social support, and the amount of accessible information. However, it also carries significant drawbacks due to the risk of exposure to contradictory, confusing, unreliable, inaccurate, or outdated information. Cyberchondria is when a person's desire to research health-related symptoms online turns into excessive anxiety and repeated online searches. This can increase a person's health-related worries and fears and lead to mental health problems such as stress, anxiety, and depression. In today's information age, adolescents spend a large part of their day on the internet using smartphones and researching the symptoms of their current illnesses online before consulting a doctor or when they receive a diagnosis. This tendency can increase their anxiety levels due to misinformation. Cyberchondria is the reflection of anxiety in the digital age. Comorbidity in psychiatric disorders has generally been evaluated, but there are only a limited number of studies investigating the level of cyberchondria in a specific disease. There are no studies examining the relationship between cyberchondria and adolescent idiopathic scoliosis. This study aims to investigate the levels of cyberchondria and related factors in patients diagnosed with scoliosis and compare them with a control group.
Přehled studie
Postavení
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Izmir, Turecko (Türkiye), 35570
- Izmir Democracy University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
This study will include patients aged 12-20 years who presented to the Physical Medicine and Rehabilitation Outpatient Clinic at Buca Seyfi Demirsoy Training and Research Hospital, Izmir Democracy University, between June 2022 and June 2025, and who were diagnosed with adolescent idiopathic scoliosis based on clinical and radiological evaluations. Individuals who underwent scoliosis X-rays during this timeframe will be retrospectively screened, and those with a Cobb angle of 10 degrees or higher on their X-rays, for whom a scoliosis diagnosis was noted in their medical history or a scoliosis diagnosis code was entered, will be included in the study's patient group.
For comparison purposes, healthy individuals with a similar age and gender distribution who presented to the outpatient clinic without any complaints and solely for routine check-ups during the 3-month period following ethics committee approval will be included as the control group.
Popis
Inclusion Criteria:
- Patients aged 12-20 years with a diagnosis of adolescent idiopathic scoliosis established through clinical and radiological evaluation (Cobb angle >10°) (patient group)
- Patients who presented to the outpatient clinic for follow-up without any complaints during a 3-month period following ethics committee approval (control group)
- Patients who were informed about the study and agreed to participate, as well as the families of eligible patients
Exclusion Criteria:
- Presence of a psychiatric disorder or use of psychotropic medications
- Presence of somatic pain disorder
- History of orthopedic, neurological, or rheumatological conditions that may affect the spine
- Pregnancy
- Participants who were informed about the study but declined to participate, as well as the families of eligible patients
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_CONTROL
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
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Group 1
Group with adolescent idiopathic scoliosis |
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Group 2
Healthy controls |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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The Cyberchondria Severity Scale
Časové okno: Day 1
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This is a psychometric measure to assess cyberchondria, a form of anxiety characterized by excessive health-related internet searches. It is a continuous scale, not a categorical one, designed specifically for cyberchondria. It is a 5-point Likert-type scale (1-Never, 2-Rarely, 3-Sometimes, 4-Often, 5-Always) consisting of 33 items and 5 subscales. Subscale questions: Compulsion (questions 3, 6, 8, 12, 14, 17, 24, 25), Distress (questions 5, 7, 10, 20, 22, 23, 29, 31), Excessiveness (questions 1, 2, 11, 13, 18, 19, 21, 30), Reassurance (questions 4, 15, 16, 26, 27, 32), Mistrust of medical professionals (questions 9, 28, 33). Questions 5, 9, 28, and 33 are reverse-scored. The scores obtained from each question are summed to calculate the individual's total cyberchondria score. The higher the score, the higher the level of cyberchondria. A validity and reliability study of the scale in Turkish has been conducted. |
Day 1
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Visual Analog Scale
Časové okno: Day 1
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Visual Analog Scale is used to measure subjectively perceived pain. It consists of a 0-10 cm scale, the most commonly used tool for quantitatively determining pain intensity, with one end representing the absence of pain and the other end representing the most severe pain possible. On this scale, '0' denotes the absence of pain, while '10' denotes the most severe pain. The individual is asked to select the numerical value that best represents their condition. This selected value is used as numerical data to determine the level of pain perception. |
Day 1
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Scoliosis Research Society-22
Časové okno: Day 1
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The Scoliosis Research Society-22 scale is a widely accepted measure developed by the Society to assess the health-related quality of life of patients with scoliosis in the United States. The reliability and validity of the Turkish version of the scale were established in 2005. he scale consists of 22 questions and 5 subscales. The subscales are: pain, assessment of general appearance, spinal function, mental health, and satisfaction with treatment. All of these sections can be evaluated separately and/or all questions can be evaluated under a total score. Scores are calculated by assigning a response value on a 5-point scale to all 22 questions. Each item includes responses ranging from negative to positive. A negative response scores 1 point, and the most positive response scores 5 points. Higher score on the scale indicate improved quality of life, while lower scores indicate a decline. |
Day 1
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Cobb's angle
Časové okno: Day 1
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The initial and terminal vertebrae of the curvature in the spinal column are identified on a scoliosis X-ray. The upper endplate of the initial vertebra and the lower endplate of the terminal vertebra are identified. Lines parallel to these endplates are drawn. The angle formed by the intersection of the vertical lines dropped from these lines is the Cobb angle. |
Day 1
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Scoliosis severity classification
Časové okno: Day 1
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Cases with a Cobb angle of 10-20 degrees are classified as mild, those with a Cobb angle of 20-40 degrees as moderate, and those with a Cobb angle of 40 degrees or higher as severe scoliosis. |
Day 1
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King-Moe Classification
Časové okno: Day 1
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The King-Moe Classification is a method for categorizing scoliosis into five types. Type 1: Thoracic and lumbar curvatures coexist, and both curvatures cross the midline. The angle of the lumbar curvature is greater. Type 2: Thoracic and lumbar curvatures coexist, and both curvatures cross the midline. The angle of the thoracic curvature is greater. Type 3: The thoracic curve is the primary curve and crosses the midline. The lumbar curve does not cross the midline. Type 4: A long thoracic curve is present. L5 is balanced over the sacrum, and L4 tilts toward the thoracic curve. Type 5: A double thoracic curve is present. T1 tilts in the upper curve. |
Day 1
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025 489
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
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