Surgeon SatisfactionNCT06553079
Development of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
An observational study of Surgeon Satisfaction and Shoulder Arthroscopy, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgeon Satisfaction, Shoulder Arthroscopy
- What is being tested?
- Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of orthopedic surgeons who specialize in shoulder arthroscopy and are actively engaged in performing these procedures. Participants will be recruited from a variety of clinical settings, including academic medical centers, private practices, and specialized orthopedic clinics. The surgeons included in the study will have diverse levels of experience, ranging from early-career surgeons with low practice to highly experienced surgeons with decades of experience in the field.
Who may be able to join
- Orthopedic Surgeons:Must be a licensed orthopedic surgeon actively performing shoulder arthroscopy procedures.
- Participants must be willing to provide informed consent and participate in both the questionnaire development (including interviews) and the validation phases of the study.
- Participants must be proficient in the language in which the questionnaire is administered to ensure accurate and meaningful responses.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including individual, patient-related, and surgical equipment-related factors. Based on the insights gained from these interviews, a comprehensive questionnaire will be developed. The questionnaire will then undergo validation processes, including assessments of content, construct, criterion, and reliability, to ensure it accurately and consistently measures surgeon satisfaction. The final validated tool is intended to provide a reliable method for surgeons to self-assess their satisfaction with shoulder arthroscopy procedures, contributing to improved surgical practices and outcomes.
Read the detailed description
The "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy" is being developed to address the need for a standardized tool to evaluate surgeon satisfaction in the context of shoulder arthroscopy. This study is structured into two primary phases: survey development and validation.
Phase 1: Survey Development In the initial phase, semi-structured interviews will be conducted with a diverse group of surgeons who specialize in shoulder arthroscopy. These interviews will explore various dimensions of surgical satisfaction, including technical factors, patient outcomes, surgical equipment performance, and team dynamics. The qualitative data obtained from these interviews will be analyzed to identify recurring themes and factors that are crucial to surgeon satisfaction. Based on these findings, a draft questionnaire will be developed, ensuring that it comprehensively covers all relevant aspects of the surgical experience.
Phase 2: Validation Process Once the questionnaire is drafted, it will undergo a rigorous validation process. Content validity will be established by consulting with a panel of experts in orthopedic surgery and psychometrics to ensure that the questionnaire items are both relevant and exhaustive. Construct validity will be tested using factor analysis to determine the underlying structure of the questionnaire and to ensure it accurately measures the intended constructs of satisfaction. Criterion validity will be assessed by comparing the questionnaire outcomes with established benchmarks or other validated tools. Additionally, the questionnaire's reliability will be evaluated through test-retest and internal consistency measures Cronbach's alpha.
- Conditions
- Surgeon Satisfaction, Shoulder Arthroscopy
- Being tested
- Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder ArthroscopyOther
The intervention in this study involves the administration of the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy," a newly developed tool designed to measure various aspects of surgeon satisfaction related to shoulder arthroscopy procedures.
| Study group | Role | What they receive |
|---|---|---|
| Surgeons Performing Shoulder Arthroscopy | This is the main group of interest and includes surgeons who regularly perform shoulder arthroscopy. They will be the primary respondents to the survey and will provide insights into the factors affecting their surgical satisfaction. Receives: Other: Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
The primary outcome measure is the successful development and psychometric validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy.
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 Sep 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgeon SatisfactionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 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
- NCT06553079
- Sponsor's protocol ID
- Iayas11
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06553079
- Acronym / sponsor ID
- Iayas11
- Conditions
- Surgeon Satisfaction, Shoulder Arthroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 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 observational study aims to develop and validate the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy." The study involves conducting in-depth interviews with surgeons who perform shoulder arthroscopy to identify key factors influencing their surgical satisfaction, including individual, patient-related, and surgical equipment-related factors. Based on the insights gained from these interviews, a comprehensive questionnaire will be developed. The questionnaire will then undergo validation processes, including assessments of content, construct, criterion, and reliability, to ensure it accurately and consistently measures surgeon satisfaction. The final validated tool is intended to provide a reliable method for surgeons to self-assess their satisfaction with shoulder arthroscopy procedures, contributing to improved surgical practices and outcomes.
Detailed description
The "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy" is being developed to address the need for a standardized tool to evaluate surgeon satisfaction in the context of shoulder arthroscopy. This study is structured into two primary phases: survey development and validation.
Phase 1: Survey Development In the initial phase, semi-structured interviews will be conducted with a diverse group of surgeons who specialize in shoulder arthroscopy. These interviews will explore various dimensions of surgical satisfaction, including technical factors, patient outcomes, surgical equipment performance, and team dynamics. The qualitative data obtained from these interviews will be analyzed to identify recurring themes and factors that are crucial to surgeon satisfaction. Based on these findings, a draft questionnaire will be developed, ensuring that it comprehensively covers all relevant aspects of the surgical experience.
Phase 2: Validation Process Once the questionnaire is drafted, it will undergo a rigorous validation process. Content validity will be established by consulting with a panel of experts in orthopedic surgery and psychometrics to ensure that the questionnaire items are both relevant and exhaustive. Construct validity will be tested using factor analysis to determine the underlying structure of the questionnaire and to ensure it accurately measures the intended constructs of satisfaction. Criterion validity will be assessed by comparing the questionnaire outcomes with established benchmarks or other validated tools. Additionally, the questionnaire's reliability will be evaluated through test-retest and internal consistency measures Cronbach's alpha.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgeons Performing Shoulder Arthroscopy | – | Other: Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder ArthroscopyThis is the main group of interest and includes surgeons who regularly perform shoulder arthroscopy. They will be the primary respondents to the survey and will provide insights into the factors affecting their surgical satisfaction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of orthopedic surgeons who specialize in shoulder arthroscopy and are actively engaged in performing these procedures. Participants will be recruited from a variety of clinical settings, including academic medical centers, private practices, and specialized orthopedic clinics. The surgeons included in the study will have diverse levels of experience, ranging from early-career surgeons with low practice to highly experienced surgeons with decades of experience in the field.
Key inclusion criteria (3 listed)
- Orthopedic Surgeons:Must be a licensed orthopedic surgeon actively performing shoulder arthroscopy procedures.
- Participants must be willing to provide informed consent and participate in both the questionnaire development (including interviews) and the validation phases of the study.
- Participants must be proficient in the language in which the questionnaire is administered to ensure accurate and meaningful responses.
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 |
|---|---|---|
| Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder ArthroscopyThe intervention in this study involves the administration of the "Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy," a newly developed tool designed to measure various aspects of surgeon satisfaction related to shoulder arthroscopy procedures. | Other | Surgeons Performing Shoulder Arthroscopy |
Primary outcome
Validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy
Time frame: 6 months
The primary outcome measure is the successful development and psychometric validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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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 Surgeon Satisfaction and Shoulder Arthroscopy, 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 3 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 14 Aug 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?
Validation of the Surgeon Satisfaction Self-Assessment Questionnaire for Shoulder Arthroscopy (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 14 Aug 2024.