Quality of LifeNCT04846296
The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
An observational study of Quality of Life and Spinal Deformity, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Quality of Life, Spinal Deformity, Scoliosis
- What is being tested?
- Questionnaire
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 15 Nov 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Aged between 10-16years old with scoliosis who treated by conservative management.
Who may be able to join
- Aged between 10-16 years old
- Cobb angle 10-40 degrees
- Being treated with conservative treatment for spinal deformities
- Being accepted to answer the questionnaire
Who cannot join
- Being not accepted to answer the questionnaire
- Having any mental disorder to prevent participation the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, 34303
About this study
The purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.
Read the detailed description
The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21-105.
The QLPSD has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL. This questionnaire is practical and suitable for patients with spinal deformities. As a result we choose to translate the QLPSD into Turkish as it is less costly, practical and time consuming than developing a new tool. QLPSD may be preferred during follow-up of the results of conservative and / or surgical treatments for spinal deformities.
- Conditions
- Quality of Life, Spinal Deformity, Scoliosis
- Being tested
- Questionnaire
- Keywords
- quality of life, scoliosis, spine, validation, adaptation
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called the Quality of Life Profile for Spinal Deformities
The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL.
| Study group | Role | What they receive |
|---|---|---|
| study group | Between 10-16 years old Cobb angle 10-40 degrees Being treated with conservative treatment (brace- exercise) for scoliosis Accepted to answer the questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish adaptation, validity and reliability of QLPSD
The questionnaire contains 21 items in five dimensions:
psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21- 105. Higher scores indicate poorer QoL.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start15 Apr 2021
- Primary completion15 Jul 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Merve Damla Korkmaz, 1, Principal investigator, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846296
- Sponsor's protocol ID
- KAEK/2021.04.121
- Status last verified
- Dec 2022
- First submitted
- 12 Apr 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Validation and Reability of the Quality of Life Profile for Spinal Deformities into Turkish population
Publications
Feise RJ, Donaldson S, Crowther ER, Menke JM, Wright JG. Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1310-5. doi: 10.1097/01.brs.0000163885.12834.ca.
PubMed 15928558Schulte TL, Thielsch MT, Gosheger G, Boertz P, Terheyden JH, Wetterkamp M. German validation of the quality of life profile for spinal disorders (QLPSD). Eur Spine J. 2018 Jan;27(1):83-92. doi: 10.1007/s00586-017-5284-3. Epub 2017 Sep 9.
PubMed 28889338
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Adaptation, Validity and Reliability Study of the Quality of Life Profile for Spinal Deformities
- ClinicalTrials.gov ID
- NCT04846296
- Acronym / sponsor ID
- KAEK/2021.04.121
- Conditions
- Quality of Life, Spinal Deformity, Scoliosis
- Keywords
- quality of life, scoliosis, spine, validation, adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Apr 2021 (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 purpose of this study is to translate and culturally adapt the quality of life profile for spinal deformities (QLPSD) to Turkish language and test the validity and reliability of Turkish version of QLPSD in patients with adolescent idiopathic scoliosis.
Detailed description
The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21-105.
The QLPSD has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL. This questionnaire is practical and suitable for patients with spinal deformities. As a result we choose to translate the QLPSD into Turkish as it is less costly, practical and time consuming than developing a new tool. QLPSD may be preferred during follow-up of the results of conservative and / or surgical treatments for spinal deformities.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: QuestionnaireBetween 10-16 years old Cobb angle 10-40 degrees Being treated with conservative treatment (brace- exercise) for scoliosis Accepted to answer the questionnaire |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Aged between 10-16years old with scoliosis who treated by conservative management.
Key inclusion criteria (4 listed)
- Aged between 10-16 years old
- Cobb angle 10-40 degrees
- Being treated with conservative treatment for spinal deformities
- Being accepted to answer the questionnaire
Key exclusion criteria (2 listed)
- Being not accepted to answer the questionnaire
- Having any mental disorder to prevent participation the study
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 |
|---|---|---|
| QuestionnaireAlso: the Quality of Life Profile for Spinal DeformitiesThe QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL. | Other | study group |
Primary outcome
Turkish adaptation, validity and reliability of QLPSD
Time frame: 1 day
The questionnaire contains 21 items in five dimensions: psychosocial functioning (7 items), sleep disturbances (4 items), back pain (3 items), body image (4 items), and back flexibility (3 items). Responses to items use a 5-point Likert scale. The possible score range is 21- 105. Higher scores indicate poorer QoL.
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 12 Dec 2022.
- Background: PubMed 15928558Feise RJ, Donaldson S, Crowther ER, Menke JM, Wright JG. Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1310-5. doi: 10.1097/01.brs.0000163885.12834.ca.
- Results publication: PubMed 28889338Schulte TL, Thielsch MT, Gosheger G, Boertz P, Terheyden JH, Wetterkamp M. German validation of the quality of life profile for spinal disorders (QLPSD). Eur Spine J. 2018 Jan;27(1):83-92. doi: 10.1007/s00586-017-5284-3. Epub 2017 Sep 9.
- Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.Link provided by the sponsor.
- German validation of the quality of life profile for spinal disorders (QLPSD)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Validation and Reability of the Quality of Life Profile for Spinal Deformities into Turkish population
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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.
Merve Damla Korkmaz, 1 principal investigator
Kanuni Sultan Suleyman Training and Research Hospital
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 Quality of Life and Spinal Deformity, run by Kanuni Sultan Suleyman Training and Research Hospital 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 2 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 12 Dec 2022. 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?
Turkish adaptation, validity and reliability of QLPSD (time frame: 1 day). 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 NCT04846296, which also lists 2 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 12 Dec 2022.