Scoliosis IdiopathicNCT07276178
Reliability of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) Questionnaire
An observational study of Scoliosis Idiopathic and Scoliosis Idiopathic Adolescent, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) questionnaire; to evaluate the reliability of the Turkish form and to ensure its usability in clinical and research fields. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis Idiopathic Adolescent, Caregiver Anxiety
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2025to 10 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample population consists of individuals who volunteered for the study and met the inclusion criteria, who had no history of other comorbidities in their children, a positive neurological examination, or previous spinal surgery. Convenience sampling will be used in sample selection.
Who may be able to join
- Individuals who are an adult (parent or primary caregiver) responsible for the care of an individual diagnosed with scoliosis between the ages of 10 and 18.
- Individuals who are able to read and understand Turkish.
- Individuals who are actively involved in the child's treatment process (e.g., use of a brace, exercise program, follow-up appointments).
- Individuals who volunteer to participate in the study.
Who cannot join
- Participants whose children have a history of other comorbidities (neurological, etc.),
- Children whose children have a history of spinal surgery,
- Individuals who do not have an active role in the care process (e.g., parents who only provide financial support),
- Caregivers with intellectual disabilities, serious psychiatric diagnoses, or cognitive impairments that limit communication,
- Participants with incomplete or invalid survey forms.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hasan Kalyoncu University
Gaziantep, Gaziantep, (505) 090-5846
Tuğba GÖNEN, Asisst. Prof. Dr., 505 090 58 46, tugba.badat@hku.edu.tr
Tuğba GÖNEN, Asisst. Prof. Dr.
About this study
Official title: Reliability of the Turkish Version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) Questionnaire
The aim of this study is to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) questionnaire; to evaluate the reliability of the Turkish form and to ensure its usability in clinical and research fields.
Read the detailed description
dependent on the involvement of families and caregivers. The emotional burden, stress, anxiety, and social limitations experienced by caregivers during the treatment process can indirectly affect both the individual's quality of life and the success of the patient's treatment. Therefore, objectively assessing the emotional and psychosocial impact experienced by caregivers of individuals with scoliosis is crucial for planning appropriate supportive interventions. The Scoliosis Caregiver Response and Emotional Scale (SCaRES), developed for this purpose, is a specific measurement tool that assesses emotional and behavioral responses to the treatment process in caregivers of individuals with scoliosis. Validity and reliability studies are required for the scale's use in different cultures and languages. Cultural differences, linguistic shifts, and healthcare system dynamics limit the scale's direct translation. Therefore, developing a Turkish version of the SCaRES is crucial for validly and reliably assessing the psychosocial burden experienced by caregivers in Turkish society. The aim of this study was to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) and to assess its reliability and ensure its usability in clinical and research settings.
- Keywords
- Scoliosis Idiopathic Adolescent, Reliability, Caregiver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis Caregiver Group | Demographic information of caregivers who met the study criteria will be recorded at the beginning of the study. In this study, written permission was obtained from the authors of the original scale to establish the reliability and psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Survey. The scale was first translated into Turkish by two independent translators, and the translations were combined and synthesized by experts (physiotherapy/rehabilitation specialists and a linguist). The resulting Turkish version was back-translated into English by an independent translator and checked for consistency with the original text. The Scoliosis Caregiver Response and Emotional Scale (SCaRES) is a specific scale developed to measure the emotional and behavioral responses of parents or primary caregivers of children or adolescents with scoliosis to the treatment process. The scale assesses dimensions such as stress, anxiety, social limitations, and |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoliosis Caregiver Affect and Emotional Questionnaire Turkish Version
The Scoliosis Caregiver Response and Emotional Scale (SCaRES) is a specific scale developed to measure the emotional and behavioral responses of parents or primary caregivers of children or adolescents with scoliosis to the treatment process. The scale assesses aspects such as stress, anxiety, social limitations, and psychosocial burden experienced during the caregiving process. The SCaRES scale consists of 18 items. Each item is scored on a Likert-type scale of 1- Never, 2- Rarely, 3- Often, and 4- Always. The total scale score indicates the caregiver's level of impact on the treatment process. A higher score indicates a greater level of emotional and behavioral impact on the caregiver.
Measured: through of the study, average 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Scoliosis IdiopathicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba GÖNEN, Hasan Kalyoncu University
- Investigators
- Tuğba GÖNEN, Asisst. Prof. Dr., Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276178
- Sponsor's protocol ID
- 2025/126
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Motyer G, Dooley B, Kiely P, Fitzgerald A. Parents' information needs, treatment concerns, and psychological well-being when their child is diagnosed with adolescent idiopathic scoliosis: A systematic review. Patient Educ Couns. 2021 Jun;104(6):1347-1355. doi: 10.1016/j.pec.2020.11.023. Epub 2020 Nov 25.
PubMed 33280964Campbell M, Matsumoto H, St Hilaire T, Roye BD, Roye DP, Vitale MG. Burden of care in families of patients with early onset scoliosis. J Pediatr Orthop B. 2020 Nov;29(6):567-571. doi: 10.1097/BPB.0000000000000711.
PubMed 31895294Shi Z, Mao Z, Xue S, Chen G, Li S. What is the relationship between health-related quality of life among scoliosis patients and their caregiver burden? A cross-sectional study in China. BMC Psychol. 2023 Oct 19;11(1):346. doi: 10.1186/s40359-023-01375-0.
PubMed 37858224Li C, Miao J, Gao X, Zheng L, Su X, Hui H, Hu J. Factors Associated with Caregiver Burden in Primary Caregivers of Patients with Adolescent Scoliosis: A Descriptive Cross-Sectional Study. Med Sci Monit. 2018 Sep 15;24:6472-6479. doi: 10.12659/MSM.909599.
PubMed 30218532Altaf F, Gibson A, Dannawi Z, Noordeen H. Adolescent idiopathic scoliosis. BMJ. 2013 Apr 30;346:f2508. doi: 10.1136/bmj.f2508. No abstract available.
PubMed 23633006Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
PubMed 18456103Zaina F, Ferrario I, Bakhsh HR, Donzelli S, Negrini S. SCaRES - scoliosis caregiver response and emotional scale: a Rasch-validated questionnaire to measure the psychological impact of children's scoliosis on their parents. Eur Spine J. 2025 Nov;34(11):5224-5231. doi: 10.1007/s00586-025-08983-x. Epub 2025 Jun 21.
PubMed 40542837
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Turkish Version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) Questionnaire
- ClinicalTrials.gov ID
- NCT07276178
- Acronym / sponsor ID
- 2025/126
- Keywords
- Scoliosis Idiopathic Adolescent, Reliability, Caregiver
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 10 Dec 2025 (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.
The aim of this study is to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) questionnaire; to evaluate the reliability of the Turkish form and to ensure its usability in clinical and research fields.
Detailed description
dependent on the involvement of families and caregivers. The emotional burden, stress, anxiety, and social limitations experienced by caregivers during the treatment process can indirectly affect both the individual's quality of life and the success of the patient's treatment. Therefore, objectively assessing the emotional and psychosocial impact experienced by caregivers of individuals with scoliosis is crucial for planning appropriate supportive interventions. The Scoliosis Caregiver Response and Emotional Scale (SCaRES), developed for this purpose, is a specific measurement tool that assesses emotional and behavioral responses to the treatment process in caregivers of individuals with scoliosis. Validity and reliability studies are required for the scale's use in different cultures and languages. Cultural differences, linguistic shifts, and healthcare system dynamics limit the scale's direct translation. Therefore, developing a Turkish version of the SCaRES is crucial for validly and reliably assessing the psychosocial burden experienced by caregivers in Turkish society. The aim of this study was to examine the psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Scale (SCaRES) and to assess its reliability and ensure its usability in clinical and research settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoliosis Caregiver Group | – | –Demographic information of caregivers who met the study criteria will be recorded at the beginning of the study. In this study, written permission was obtained from the authors of the original scale to establish the reliability and psychometric properties of the Turkish version of the Scoliosis Caregiver Response and Emotional Survey. The scale was first translated into Turkish by two independent translators, and the translations were combined and synthesized by experts (physiotherapy/rehabilitation specialists and a linguist). The resulting Turkish version was back-translated into English by an independent translator and checked for consistency with the original text. The Scoliosis Caregiver Response and Emotional Scale (SCaRES) is a specific scale developed to measure the emotional and behavioral responses of parents or primary caregivers of children or adolescents with scoliosis to the treatment process. The scale assesses dimensions such as stress, anxiety, social limitations, and |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample population consists of individuals who volunteered for the study and met the inclusion criteria, who had no history of other comorbidities in their children, a positive neurological examination, or previous spinal surgery. Convenience sampling will be used in sample selection.
Key inclusion criteria (4 listed)
- Individuals who are an adult (parent or primary caregiver) responsible for the care of an individual diagnosed with scoliosis between the ages of 10 and 18.
- Individuals who are able to read and understand Turkish.
- Individuals who are actively involved in the child's treatment process (e.g., use of a brace, exercise program, follow-up appointments).
- Individuals who volunteer to participate in the study.
Key exclusion criteria (5 listed)
- Participants whose children have a history of other comorbidities (neurological, etc.),
- Children whose children have a history of spinal surgery,
- Individuals who do not have an active role in the care process (e.g., parents who only provide financial support),
- Caregivers with intellectual disabilities, serious psychiatric diagnoses, or cognitive impairments that limit communication,
- Participants with incomplete or invalid survey forms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scoliosis Caregiver Affect and Emotional Questionnaire Turkish Version
Time frame: through of the study, average 6 months
The Scoliosis Caregiver Response and Emotional Scale (SCaRES) is a specific scale developed to measure the emotional and behavioral responses of parents or primary caregivers of children or adolescents with scoliosis to the treatment process. The scale assesses aspects such as stress, anxiety, social limitations, and psychosocial burden experienced during the caregiving process. The SCaRES scale consists of 18 items. Each item is scored on a Likert-type scale of 1- Never, 2- Rarely, 3- Often, and 4- Always. The total scale score indicates the caregiver's level of impact on the treatment process. A higher score indicates a greater level of emotional and behavioral impact on the caregiver.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 33280964Motyer G, Dooley B, Kiely P, Fitzgerald A. Parents' information needs, treatment concerns, and psychological well-being when their child is diagnosed with adolescent idiopathic scoliosis: A systematic review. Patient Educ Couns. 2021 Jun;104(6):1347-1355. doi: 10.1016/j.pec.2020.11.023. Epub 2020 Nov 25.
- Results publication: PubMed 31895294Campbell M, Matsumoto H, St Hilaire T, Roye BD, Roye DP, Vitale MG. Burden of care in families of patients with early onset scoliosis. J Pediatr Orthop B. 2020 Nov;29(6):567-571. doi: 10.1097/BPB.0000000000000711.
- Results publication: PubMed 37858224Shi Z, Mao Z, Xue S, Chen G, Li S. What is the relationship between health-related quality of life among scoliosis patients and their caregiver burden? A cross-sectional study in China. BMC Psychol. 2023 Oct 19;11(1):346. doi: 10.1186/s40359-023-01375-0.
- Results publication: PubMed 30218532Li C, Miao J, Gao X, Zheng L, Su X, Hui H, Hu J. Factors Associated with Caregiver Burden in Primary Caregivers of Patients with Adolescent Scoliosis: A Descriptive Cross-Sectional Study. Med Sci Monit. 2018 Sep 15;24:6472-6479. doi: 10.12659/MSM.909599.
- Results publication: PubMed 23633006Altaf F, Gibson A, Dannawi Z, Noordeen H. Adolescent idiopathic scoliosis. BMJ. 2013 Apr 30;346:f2508. doi: 10.1136/bmj.f2508. No abstract available.
- Results publication: PubMed 18456103Weinstein SL, Dolan LA, Cheng JC, Danielsson A, Morcuende JA. Adolescent idiopathic scoliosis. Lancet. 2008 May 3;371(9623):1527-37. doi: 10.1016/S0140-6736(08)60658-3.
- Results publication: PubMed 40542837Zaina F, Ferrario I, Bakhsh HR, Donzelli S, Negrini S. SCaRES - scoliosis caregiver response and emotional scale: a Rasch-validated questionnaire to measure the psychological impact of children's scoliosis on their parents. Eur Spine J. 2025 Nov;34(11):5224-5231. doi: 10.1007/s00586-025-08983-x. Epub 2025 Jun 21.
- Individual participant dataSharing planned: No
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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.
Tuğba GÖNEN, Asisst. Prof. Dr. principal investigator
Hasan Kalyoncu University
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 Scoliosis Idiopathic and Scoliosis Idiopathic Adolescent, 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba GÖNEN, Asisst. Prof. Dr. (505 090 58 46, tugba.badat@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoliosis Caregiver Affect and Emotional Questionnaire Turkish Version (time frame: through of the study, average 6 months). 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 NCT07276178, which also lists 7 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 10 Dec 2025.