Shoulder SurgeryNCT06553092
Turkish Validity and Reliability Study of Hospital for Special Surgery Shoulder Surgery Expectations Survey
An observational study of Shoulder Surgery, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the Turkish validity and reliability of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. By translating the original survey into Turkish and administering it to a sample of patients who have undergone shoulder surgery, the research seeks to determine whether the survey… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shoulder Surgery
- What is being tested?
- Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 30 Mar 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of native Turkish-speaking patients who have undergone shoulder surgery at various hospitals and clinics in Turkey. These patients will include adults of all ages, both male and female, who have received a diagnosis requiring surgical intervention for shoulder conditions such as rotator cuff tears, shoulder impingement, labral tears, or shoulder instability.
Who may be able to join
- Underwent Shoulder Surgery
- Native Turkish Speakers
- Adults (18 years and older)
- Consent to Participate
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital
Ankara, Ankara, 06500
About this study
This study aims to evaluate the Turkish validity and reliability of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. By translating the original survey into Turkish and administering it to a sample of patients who have undergone shoulder surgery, the research seeks to determine whether the survey maintains its accuracy and consistency in the Turkish context. The study will involve statistical analyses to assess the survey's reliability, internal consistency, and construct validity, ensuring that the tool is culturally appropriate and effective for Turkish-speaking patients.
Read the detailed description
The process begins with the translation of the original survey into Turkish, followed by a back-translation to ensure accuracy. The adapted survey is then reviewed by a panel of experts to confirm its cultural relevance and clarity.
Once finalized, the Turkish version of the survey is administered to a cohort of Turkish-speaking patients who have undergone shoulder surgery. Participants complete the survey at a designated time point, typically postoperatively, to assess their expectations and outcomes related to the surgery. The collected data are then analyzed to evaluate the survey's reliability (internal consistency, test-retest reliability) and validity (content, construct, and criterion validity) within this specific population.
The goal of the intervention is to ensure that the Turkish version of the survey is a reliable and valid tool for assessing patient expectations and satisfaction following shoulder surgery, making it suitable for use in clinical practice and research in Turkey.
- Conditions
- Shoulder Surgery
- Being tested
- Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations SurveyOther
The Hospital for Special Surgery (HSS) Shoulder Surgery Expectations Survey is a patient-reported outcome measure designed to assess a patient's expectations before undergoing shoulder surgery. It helps clinicians understand what patients anticipate regarding pain relief, functional improvement, and overall recovery from the procedure.The HSS Shoulder Surgery Expectations Survey contains 20 questions. Each question addresses a specific aspect of shoulder function or a potential outcome that patients might expect from their surgery.Each question is scored between 1-5.It is evaluated out of a total of 80 points. A higher score indicates a greater expectation of improvement.
| Study group | Role | What they receive |
|---|---|---|
| urkish-Speaking Patients Undergoing Shoulder Surgery | This cohort consists of Turkish-speaking patients who have undergone shoulder surgery. Participants will complete the Turkish version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. Receives: Other: Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability of the Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey
The primary outcome measure is to evaluate the psychometric properties of the Turkish version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. This includes assessing the survey's internal consistency, test-retest reliability, content validity, construct validity, and criterion validity in a cohort of Turkish-speaking patients who have undergone shoulder surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Ulunay Kanatlı, Professor, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553092
- Sponsor's protocol ID
- Iayas12
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability Study of Hospital for Special Surgery Shoulder Surgery Expectations Survey
- ClinicalTrials.gov ID
- NCT06553092
- Acronym / sponsor ID
- Iayas12
- Conditions
- Shoulder Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 14 Aug 2024 (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.
This study aims to evaluate the Turkish validity and reliability of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. By translating the original survey into Turkish and administering it to a sample of patients who have undergone shoulder surgery, the research seeks to determine whether the survey maintains its accuracy and consistency in the Turkish context. The study will involve statistical analyses to assess the survey's reliability, internal consistency, and construct validity, ensuring that the tool is culturally appropriate and effective for Turkish-speaking patients.
Detailed description
The process begins with the translation of the original survey into Turkish, followed by a back-translation to ensure accuracy. The adapted survey is then reviewed by a panel of experts to confirm its cultural relevance and clarity.
Once finalized, the Turkish version of the survey is administered to a cohort of Turkish-speaking patients who have undergone shoulder surgery. Participants complete the survey at a designated time point, typically postoperatively, to assess their expectations and outcomes related to the surgery. The collected data are then analyzed to evaluate the survey's reliability (internal consistency, test-retest reliability) and validity (content, construct, and criterion validity) within this specific population.
The goal of the intervention is to ensure that the Turkish version of the survey is a reliable and valid tool for assessing patient expectations and satisfaction following shoulder surgery, making it suitable for use in clinical practice and research in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| urkish-Speaking Patients Undergoing Shoulder Surgery | – | Other: Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations SurveyThis cohort consists of Turkish-speaking patients who have undergone shoulder surgery. Participants will complete the Turkish version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of native Turkish-speaking patients who have undergone shoulder surgery at various hospitals and clinics in Turkey. These patients will include adults of all ages, both male and female, who have received a diagnosis requiring surgical intervention for shoulder conditions such as rotator cuff tears, shoulder impingement, labral tears, or shoulder instability.
Key inclusion criteria (4 listed)
- Underwent Shoulder Surgery
- Native Turkish Speakers
- Adults (18 years and older)
- Consent to Participate
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations SurveyThe Hospital for Special Surgery (HSS) Shoulder Surgery Expectations Survey is a patient-reported outcome measure designed to assess a patient's expectations before undergoing shoulder surgery. It helps clinicians understand what patients anticipate regarding pain relief, functional improvement, and overall recovery from the procedure.The HSS Shoulder Surgery Expectations Survey contains 20 questions. Each question addresses a specific aspect of shoulder function or a potential outcome that patients might expect from their surgery.Each question is scored between 1-5.It is evaluated out of a total of 80 points. A higher score indicates a greater expectation of improvement. | Other | urkish-Speaking Patients Undergoing Shoulder Surgery |
Primary outcome
Validity and Reliability of the Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey
Time frame: 6 months
The primary outcome measure is to evaluate the psychometric properties of the Turkish version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey. This includes assessing the survey's internal consistency, test-retest reliability, content validity, construct validity, and criterion validity in a cohort of Turkish-speaking patients who have undergone shoulder surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Ulunay Kanatlı, Professor study director
Gazi 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 Shoulder Surgery, run by Gazi 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 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İnci H Ayas, Msc ((0312) 216 26 01, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability of the Turkish Version of the Hospital for Special Surgery Shoulder Surgery Expectations Survey (time frame: 6 months). 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 19 Sep 2024.