Scoliosis Idiopathic AdolescentNCT07714993
Family Education for Individuals With Adolescent Idiopathic Scoliosis
A study testing PSSE and individual/family education in people with Scoliosis Idiopathic Adolescent and Scoliosis Idiopathic Adolescent Treatment, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Scoliosis Idiopathic Adolescent Treatment
- What is being tested?
- PSSE and individual/family education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Sep 2025to 10 Jun 2026
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- - Having a psychiatric diagnosis
- Having a neurological problem
- Having undergone spinal surgery
- Presence of orthopedic or cognitive problems that would hinder exercise training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Adolescent Individuals With Idiopathic Scoliosis
Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis, Gaziantep 2026. This study was conducted to investigate the effect of individual/family education on stress, deformity perception, quality of life, and exercise adherence in individuals with adolescent idiopathic scoliosis (AIS). A total of 42 individuals with AIS participated in the study. Randomization was performed to create a study group (n=21) and a control group (n=21). The study group received Physiotherapy Scoliosis-Specific Exercises (PSSE) in addition to individual/family education, while the control group received only PSSE.
Read the detailed description
Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis, Gaziantep 2026. This study was conducted to investigate the effect of individual/family education on stress, deformity perception, quality of life, and exercise adherence in individuals with adolescent idiopathic scoliosis (AIS). A total of 42 individuals with AIS participated in the study. Randomization was performed to create a study group (n=21) and a control group (n=21). The study group received Physiotherapy Scoliosis-Specific Exercises (PSSE) in addition to individual/family education, while the control group received only PSSE. Demographic information of individuals was obtained, Cobb angles and Risser values were measured using antero-posterior radiography, and trunk rotation degrees were determined by performing a forward bending test. Stress levels were assessed using the Adolescent Stress-Eusor Scale (ASES), anxiety and depression levels using the Revised Child Anxiety and Depression Scale (CADS-Y), deformity perception using the Walter Reed Visual Assessment Scale (WRVAS), Spinal Appearance Questionnaire (Tr-SAQ), and Scoliosis Body Image Scale, quality of life using the General Quality of Life Scale for Children (GQL), Scoliosis Japanese Questionnaire (SJ-27), Scoliosis Research Society-22 (SRS-22) Questionnaire, and exercise adherence level using the Exercise Adherence Rating Scale (EARS).
- Being tested
- PSSE, individual/family education
- Keywords
- scoliosis, Adolescence,, stress, body image
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSSEOther
While the study group received individual/family education in addition to Physiotherapeutic Scoliosis-Specific Exercises (PSSE), the control group received only PSSE.
individual/family educationOther
Individual/family education was provided.
| Study group | Role | What they receive |
|---|---|---|
| Working group | Experimental | The study group received additional individual/family education on 'Physiotherapeutic Scoliosis-Specific Exercises'. Receives: Other: PSSE; Other: individual/family education |
| control group | Active comparator | Only scoliosis-specific physiotherapeutic exercises were administered. Receives: Other: PSSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress-Eustress Scale for Adolescents
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.
Measured: 12 weeks
axial trunk rotation measurement (ATR)
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.
Measured: 12 Weeks
Revised Child Anxiety and Depression Scale
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.
Measured: 12 weeks
Spinal Appearance Questionnaire
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.
Measured: 12 weeks
Walter Reed Visual Assessment Scale
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.
Measured: 12 weeks
Scoliosis-Related Body Image Scale
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.
Measured: 12 weeks
General Quality of Life Scale for Children
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.
Measured: 12 weeks
Japanese Scoliosis Questionnaire (SJ-27)
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.
Measured: 12 weeks
Scoliosis Research Society Score (SRS 22)
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.
Measured: 12 weeks
Exercise Adherence Rating Scale
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start6 Sep 2025
- Primary completion30 May 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yağmur Kirmik, Hasan Kalyoncu University
- Investigators
- YAVUZ Y YAKUT, Principal investigator, Hasan Kalyoncu Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714993
- Sponsor's protocol ID
- HKU-FTR-YK-2
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient individual privacy
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Adolescent Individuals With Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07714993
- Acronym / sponsor ID
- HKU-FTR-YK-2
- Keywords
- scoliosis, Adolescence,, stress, body image
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 20 Jul 2026 (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.
Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis, Gaziantep 2026. This study was conducted to investigate the effect of individual/family education on stress, deformity perception, quality of life, and exercise adherence in individuals with adolescent idiopathic scoliosis (AIS). A total of 42 individuals with AIS participated in the study. Randomization was performed to create a study group (n=21) and a control group (n=21). The study group received Physiotherapy Scoliosis-Specific Exercises (PSSE) in addition to individual/family education, while the control group received only PSSE.
Detailed description
Yağmur KİRMİK, Investigation of the Effect of Family Education on Stress, Deformity Perception, Quality of Life, and Treatment Adherence in Individuals with Adolescent Idiopathic Scoliosis, Hasan Kalyoncu University, Graduate Education Institute, Department of Physiotherapy and Rehabilitation, Master's Thesis, Gaziantep 2026. This study was conducted to investigate the effect of individual/family education on stress, deformity perception, quality of life, and exercise adherence in individuals with adolescent idiopathic scoliosis (AIS). A total of 42 individuals with AIS participated in the study. Randomization was performed to create a study group (n=21) and a control group (n=21). The study group received Physiotherapy Scoliosis-Specific Exercises (PSSE) in addition to individual/family education, while the control group received only PSSE. Demographic information of individuals was obtained, Cobb angles and Risser values were measured using antero-posterior radiography, and trunk rotation degrees were determined by performing a forward bending test. Stress levels were assessed using the Adolescent Stress-Eusor Scale (ASES), anxiety and depression levels using the Revised Child Anxiety and Depression Scale (CADS-Y), deformity perception using the Walter Reed Visual Assessment Scale (WRVAS), Spinal Appearance Questionnaire (Tr-SAQ), and Scoliosis Body Image Scale, quality of life using the General Quality of Life Scale for Children (GQL), Scoliosis Japanese Questionnaire (SJ-27), Scoliosis Research Society-22 (SRS-22) Questionnaire, and exercise adherence level using the Exercise Adherence Rating Scale (EARS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.The aim of this study is to examine the effects of additional individual/family education alongside PSSE on stress, anxiety, depression, quality of life, deformity perception, and treatment adherence.
| Arm | Type | Receives |
|---|---|---|
| Working group | Experimental | Other: PSSE, Other: individual/family educationThe study group received additional individual/family education on 'Physiotherapeutic Scoliosis-Specific Exercises'. |
| control group | Active comparator | Other: PSSEOnly scoliosis-specific physiotherapeutic exercises were administered. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- - Having a psychiatric diagnosis
- Having a neurological problem
- Having undergone spinal surgery
- Presence of orthopedic or cognitive problems that would hinder exercise training
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 |
|---|---|---|
| PSSEWhile the study group received individual/family education in addition to Physiotherapeutic Scoliosis-Specific Exercises (PSSE), the control group received only PSSE. | Other | Working group, control group |
| individual/family educationIndividual/family education was provided. | Other | Working group |
Primary outcome
Distress-Eustress Scale for Adolescents
Time frame: 12 weeks
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.
axial trunk rotation measurement (ATR)
Time frame: 12 Weeks
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.
Revised Child Anxiety and Depression Scale
Time frame: 12 weeks
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.
Spinal Appearance Questionnaire
Time frame: 12 weeks
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.
Walter Reed Visual Assessment Scale
Time frame: 12 weeks
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.
Scoliosis-Related Body Image Scale
Time frame: 12 weeks
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.
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.
Japanese Scoliosis Questionnaire (SJ-27)
Time frame: 12 weeks
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.
Scoliosis Research Society Score (SRS 22)
Time frame: 12 weeks
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.
Exercise Adherence Rating Scale
Time frame: 12 weeks
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.
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 20 Jul 2026.
- Individual participant dataSharing planned: No. patient individual privacy
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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.
YAVUZ Y YAKUT principal investigator
Hasan Kalyoncu Universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSSE and individual/family education in people with Scoliosis Idiopathic Adolescent and Scoliosis Idiopathic Adolescent Treatment, run by Hasan Kalyoncu University 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 5 inclusion and 4 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 20 Jul 2026. 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?
Distress-Eustress Scale for Adolescents (time frame: 12 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.