- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07714993
Family Education for Individuals With Adolescent Idiopathic Scoliosis
The Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Adolescent Individuals With Idiopathic Scoliosis
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Gaziantep, Turkey (Türkiye), 27010
- Universty
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between the ages of 10 and 18
- Absence of chest deformity
- Absence of psychiatric diagnosis and not taking medication
- Absence of neurological problems
- No history of spinal surgery
Exclusion Criteria:
- - Having a psychiatric diagnosis
- Having a neurological problem
- Having undergone spinal surgery
- Presence of orthopedic or cognitive problems that would hinder exercise training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Working group
The study group received additional individual/family education on 'Physiotherapeutic Scoliosis-Specific Exercises'.
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While the study group received individual/family education in addition to Physiotherapeutic Scoliosis-Specific Exercises (PSSE), the control group received only PSSE.
Individual/family education was provided.
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Active Comparator: control group
Only scoliosis-specific physiotherapeutic exercises were administered.
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While the study group received individual/family education in addition to Physiotherapeutic Scoliosis-Specific Exercises (PSSE), the control group received only PSSE.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Distress-Eustress Scale for Adolescents
Time Frame: 12 weeks
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Each item is rated on a scale of 0 to 4. Scores for the distress and eustress dimensions range from 0 to 20.
No total score is calculated for the scale.
Higher scores on the eustress dimension indicate that stress is perceived as stimulating and motivating, whereas higher scores on the distress dimension indicate that stress is perceived as a source of strain and tension.
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12 weeks
|
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axial trunk rotation measurement (ATR)
Time Frame: 12 Weeks
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ATR is measured using a scoliometer.
The scoliometer is a tool designed to measure the prominence (gibbosity) on the back resulting from trunk rotation.
Its degree is determined by taking a measurement over the trunk prominence caused by rotation while performing the Adam's forward-bending test.
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12 Weeks
|
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Revised Child Anxiety and Depression Scale
Time Frame: 12 weeks
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The total scale score is calculated by summing the scores obtained from all items.
As the total score increases, the levels of anxiety and depression increase.
|
12 weeks
|
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Spinal Appearance Questionnaire
Time Frame: 12 weeks
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The questionnaire consists of two sub-groups.
The "Appearance" sub-group includes visual questions regarding spinal asymmetry, rib prominence, waist prominence, the relationship between the head, rib cage, and pelvis, head-to-pelvis positioning, shoulder level, and scapular rotation.
The score for the Appearance sub-group is calculated by summing the scores of questions 1 through 10; higher scores in this sub-dimension indicate a perception of severe deformity.
The "Expectation" sub-group contains questions reflecting the individual's expectations regarding their body, such as a desire to be straighter.
The score for the Expectation sub-group is calculated by summing the scores from questions 12 through 15.
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12 weeks
|
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Walter Reed Visual Assessment Scale
Time Frame: 12 weeks
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The survey items are rated on a scale of 1 to 5, with total scores ranging from a minimum of 7 to a maximum of 35.
Higher scores reflect a perception of worsening deformity.
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12 weeks
|
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Scoliosis-Related Body Image Scale
Time Frame: 12 weeks
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Consisting of seven items and a single factor, this scale measures the dissatisfaction experienced by individuals diagnosed with scoliosis regarding the deformity of their bodies. Each item is scored on a scale of 1 to 5. Higher scores indicate severe dissatisfaction with the body deformity. |
12 weeks
|
|
General Quality of Life Scale for Children
Time Frame: 12 weeks
|
This is a General Quality of Life scale comprising items related to physical health (8 items), emotional state (5 items), social status (5 items), and school functioning (5 items). The lower the total scale score, the lower the perceived quality of life. Parent forms are available for the scale-tailored to the 8-12 and 13-18 age groups-and are completed separately but simultaneously by the parents of the participating children. The 23-item scale is scored across three dimensions: Total Scale Score (TSS), Physical Health Total Score (PHTS), and Psychosocial Health Total Score (PSTS). Items are scored on a scale of 0 to 100, with response parameters assigned as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. The TSS is calculated by dividing the sum of all scores by 23; the PHTS is calculated by dividing the sum of the scores from the first 8 items by 8; and the PSTS is calculated by dividing the sum of the scores from the remaining 15 items by 15. |
12 weeks
|
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Japanese Scoliosis Questionnaire (SJ-27)
Time Frame: 12 weeks
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It is a self-administered, disease-specific questionnaire designed to measure quality of life.
It comprises four questions regarding pain associated with sitting, standing, and lying down; six questions assessing anxiety and depression related to spinal deformity; six questions addressing body image and self-perception; four questions concerning the difficulty of participating in physical activities; and seven questions regarding discomfort experienced while carrying bags or getting dressed.
Each question is scored on a scale of 0 to 4, with higher scores indicating lower quality of life.
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12 weeks
|
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Scoliosis Research Society Score (SRS 22)
Time Frame: 12 weeks
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The questionnaire consists of 22 items across five sub-domains: perception of body image, pain, function, psychosocial status, and treatment satisfaction.
Each item is scored on a scale of 1 to 5, where a score of 1 indicates a worsening condition and a score of 5 indicates a good condition.
A higher total score reflects a better quality of life.
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12 weeks
|
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Exercise Adherence Rating Scale
Time Frame: 12 weeks
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It evaluates the level of adherence to home exercises among patients with chronic diseases.
It consists of three sections.
Section A comprises six items that can be adapted to individual needs; it is not included in the scoring.
Section B describes how the recommended home exercises are performed, while Section C assesses the reasons for adherence or non-adherence to the recommended exercises.
The total questionnaire score is calculated by summing the scores from Sections B and C, with values ranging from 0 to 64.
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: YAVUZ Y YAKUT, Hasan Kalyoncu Universty
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- HKU-FTR-YK-2
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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