Healthy VolunteersNCT03728088
Cross-sectional Analysis of Non-technical Attributes and Surgical Experience in Surgical Staff, Trainees and Applicants.
An observational study of Healthy Volunteers, run by University Ghent.
Trial summary
This study consists of an analysis of the communication styles and attitudes towards risk and uncertainty (i.e. non-technical attributes) in a surgical population with varying clinical experience. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Rating scales concerning non-technical attributes
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Oct 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
- Child, Adult, Older adult
Study population: Candidates applying for a surgical specialty (general surgery, orthopaedics, urology, plastic surgery); trainees in one of these surgical specialties; staff members in one of these surgical specialties.
Who may be able to join
- Participant is part of any of the following groups:
- Applicant for surgical training in general surgery, orthopedics, urology or plastic surgery.
- Trainee in general surgery, orthopedics, urology, plastic surgery.
- Staff in general surgery, orthopedics, urology, plastic surgery.
- Participant is active at Ghent University Hospital or an affiliated training hospital.
- No exclusion criteria apply to this study.
Who cannot join
None listed.
About this study
Official title: Non-technical Attributes and Surgical Experience: a Cross-sectional Study Comparing Communication Styles and Attitudes in Surgical Staff, Trainees and Applicants
This study consists of an analysis of the communication styles and attitudes towards risk and uncertainty (i.e. non-technical attributes) in a surgical population with varying clinical experience.
The study aims to investigate the differences and specific patterns in non-technical attributes that may be discerned in these groups and how these non technical attributes develop throughout surgical training.
Read the detailed description
This study evaluated the communication styles and attitudes towards risk and uncertainty in a population of surgical candidates (pre- and postgraduates), surgical trainees and surgical staff members, from the specialties of general surgery, orthopedics, urology and plastic surgery. After signing informed consent, participants complete an on-line questionnaire, which contains a set of validated tools.
Initially, a cross-sectional analysis of the non-technical attributes will be conducted, to identify any patters, similarities or differences between participant groups.
The study hypothesis is that significant differences can be observed in participant attributes, which relate to their clinical experience.
Additionally, surgical candidates who agree to participate in this study and are accepted for a surgical training in either general surgery, orthopaedics, urology or plastic surgery, will be invited to repeat the questionnaire at a 2-year interval, to investigate the evolution of their non-technical attributes throughout their training and to identify general patterns.
- Conditions
- Healthy Volunteers
- Being tested
- Rating scales concerning non-technical attributes
- Keywords
- Non-technical attributes, Surgical training, Communication style, Risk aversion, Reaction to uncertainty, Self-assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rating scales concerning non-technical attributesOther
Also called Communication styles inventory (CSI-96) rating scale, Physician's reactions towards uncertainty (PRU) rating scale, Physicians's risk attitudes (PRA) rating scale
| Study group | Role | What they receive |
|---|---|---|
| Surgical Candidates | Under- and postgraduate candidates applying for surgical training in general surgery, orthopedics, urology or plastic surgery at Ghent University Hospital.
All candidates will complete the rating scales concerning non-technical attributes in the period prior to the surgical selections. Receives: Other: Rating scales concerning non-technical attributes | |
| Surgical trainees | Surgical trainees active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital or an affiliated non-academic training hospital.
All trainees will be invited to participate in the study. Trainees who agree to participate will complete the rating scales concerning non-technical attributes. Receives: Other: Rating scales concerning non-technical attributes | |
| Surgical staff | Surgical staff members active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital.
All surgical staff members will be invited to participate in the study. Surgical staff members who agree to participate will complete the rating scales concerning non-technical attributes. Receives: Other: Rating scales concerning non-technical attributes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant communication styles
Communication Styles Inventory-96 scale:Subdomains: Expressiveness (range: 1-5); Preciseness (range: 1-5); Verbal aggressiveness (range: 1-5); Questioningness (range: 1-5); Emotionality (range: 1-5); Impression manipulativeness (range: 1-5)
Measured: Rating scale is completed by all groups on study inclusion, after signing informed consent.
Participant attitudes towards uncertainty
Physicians' Reactions to Uncertainty (PRU) scale: Anxiety due to uncertainty (Range: 5-30
); Concern about bad outcomes (3-18); Reluctance to disclose uncertainty to patients (Range: 5-30); Reluctance to disclose mistakes to physicians (Range 2-12)
Measured: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion
Participant attitudes towards taking risks
Physicians' risk attitude (PRA) Scale (Range: 2-12)
Measured: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion
Secondary outcomes (1)
Participant perceived actual health status
Short Form-36 scale (Range: 10-50)
Measured: Rating scale is completed by all groups on study inclusion, after signing informed consent.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Sep 2016
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Van Herzeele, MD, PhD, Principal investigator, Vascular surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728088
- Sponsor's protocol ID
- B670201628799
- Status last verified
- Jul 2024
- First submitted
- 23 Oct 2018
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data will not be shared standard.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-technical Attributes and Surgical Experience: a Cross-sectional Study Comparing Communication Styles and Attitudes in Surgical Staff, Trainees and Applicants
- ClinicalTrials.gov ID
- NCT03728088
- Acronym / sponsor ID
- B670201628799
- Conditions
- Healthy Volunteers
- Keywords
- Non-technical attributes, Surgical training, Communication style, Risk aversion, Reaction to uncertainty, Self-assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Nov 2018 (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 consists of an analysis of the communication styles and attitudes towards risk and uncertainty (i.e. non-technical attributes) in a surgical population with varying clinical experience.
The study aims to investigate the differences and specific patterns in non-technical attributes that may be discerned in these groups and how these non technical attributes develop throughout surgical training.
Detailed description
This study evaluated the communication styles and attitudes towards risk and uncertainty in a population of surgical candidates (pre- and postgraduates), surgical trainees and surgical staff members, from the specialties of general surgery, orthopedics, urology and plastic surgery. After signing informed consent, participants complete an on-line questionnaire, which contains a set of validated tools.
Initially, a cross-sectional analysis of the non-technical attributes will be conducted, to identify any patters, similarities or differences between participant groups.
The study hypothesis is that significant differences can be observed in participant attributes, which relate to their clinical experience.
Additionally, surgical candidates who agree to participate in this study and are accepted for a surgical training in either general surgery, orthopaedics, urology or plastic surgery, will be invited to repeat the questionnaire at a 2-year interval, to investigate the evolution of their non-technical attributes throughout their training and to identify general patterns.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Surgical Candidates | – | Other: Rating scales concerning non-technical attributesUnder- and postgraduate candidates applying for surgical training in general surgery, orthopedics, urology or plastic surgery at Ghent University Hospital. All candidates will complete the rating scales concerning non-technical attributes in the period prior to the surgical selections. |
| Surgical trainees | – | Other: Rating scales concerning non-technical attributesSurgical trainees active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital or an affiliated non-academic training hospital. All trainees will be invited to participate in the study. Trainees who agree to participate will complete the rating scales concerning non-technical attributes. |
| Surgical staff | – | Other: Rating scales concerning non-technical attributesSurgical staff members active in general surgery, orthopaedics, urology or plastic surgery, at Ghent University Hospital. All surgical staff members will be invited to participate in the study. Surgical staff members who agree to participate will complete the rating scales concerning non-technical attributes. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Candidates applying for a surgical specialty (general surgery, orthopaedics, urology, plastic surgery); trainees in one of these surgical specialties; staff members in one of these surgical specialties.
Key inclusion criteria (6 listed)
- Participant is part of any of the following groups:
- Participant is active at Ghent University Hospital or an affiliated training hospital.
- No exclusion criteria apply to this study.
Key exclusion criteria (0 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 |
|---|---|---|
| Rating scales concerning non-technical attributesAlso: Communication styles inventory (CSI-96) rating scale, Physician's reactions towards uncertainty (PRU) rating scale, Physicians's risk attitudes (PRA) rating scale | Other | Surgical Candidates, Surgical staff, Surgical trainees |
Primary outcome
Participant communication styles
Time frame: Rating scale is completed by all groups on study inclusion, after signing informed consent.
Communication Styles Inventory-96 scale:Subdomains: Expressiveness (range: 1-5); Preciseness (range: 1-5); Verbal aggressiveness (range: 1-5); Questioningness (range: 1-5); Emotionality (range: 1-5); Impression manipulativeness (range: 1-5)
Participant attitudes towards uncertainty
Time frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion
Physicians' Reactions to Uncertainty (PRU) scale: Anxiety due to uncertainty (Range: 5-30 ); Concern about bad outcomes (3-18); Reluctance to disclose uncertainty to patients (Range: 5-30); Reluctance to disclose mistakes to physicians (Range 2-12)
Participant attitudes towards taking risks
Time frame: Rating scale is completed by all groups on study inclusion, after signing informed consent. For the candidate group, this measure is repeated on a selection day during the surgical selection process, +- 1 - 2 months after study inclusion
Physicians' risk attitude (PRA) Scale (Range: 2-12)
1 secondary outcome
Participant perceived actual health status
Time frame: Rating scale is completed by all groups on study inclusion, after signing informed consent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No. Research data will not be shared standard.
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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.
Isabelle Van Herzeele, MD, PhD principal investigator
Vascular surgeon
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University Ghent.
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 6 inclusion and 0 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Participant communication styles (time frame: Rating scale is completed by all groups on study inclusion, after signing informed consent.). The study lists 3 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 8 Jul 2024.