- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481071
Cyberchondria in Adolescents With Idiopathic Scoliosis
Adölesan İdiyopatik Skolyozlu Hastalarda Siberkondri Düzeyi ve İlişkili Faktörler: Olgu-Kontrol Çalışması
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Kadir Songür, Assoc. Prof.
- Phone Number: +905054529231
- Email: kadir.93@gmail.com
Study Locations
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Izmir, Turkey (Türkiye), 35570
- Recruiting
- Izmir Democracy University
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Contact:
- Kadir Songür
- Phone Number: +905054529231
- Email: kadir.93@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group 1
Group with adolescent idiopathic scoliosis
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Group 2
Healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Cyberchondria Severity Scale
Time Frame: 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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual Analog Scale
Time Frame: 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.
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Day 1
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Scoliosis Research Society-22
Time Frame: 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.
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Day 1
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Cobb's angle
Time Frame: 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.
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Day 1
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Scoliosis severity classification
Time Frame: 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.
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Day 1
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King-Moe Classification
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025 489
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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