Surgical Procedure, UnspecifiedNCT03957889
Students and Trainers' Evaluations Correlation
An observational study of Surgical Procedure, Unspecified and Critical Thinking, run by Centre de l'arthrose, Paris.
Trial summary
The delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing ("students") (2) and to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedure, Unspecified, Critical Thinking, Simulation
- What is being tested?
- Educational simulation
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We divided Students into groups of 10 to 12 students, distributed into 5 sessions over the study period. We paid attention to mix these groups according to various places of exercise, surgical skills, length of professional practice and sectors of public or private activities. This group allocation was intended to enrich the exchanges between students by providing diverse personal and professional experiences, while maintaining a balance between the groups.
Who may be able to join
- scrub nurses already in practice
- professional trainer, specialist in the field of the proposed course subject
Who cannot join
None listed.
About this study
Official title: Correlation Between Students' and Trainers' Evaluations While Learning Delegated Surgical Procedures: a Prospective Cohort Study
The delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing ("students") (2) and to evaluate the correlation between the evaluation of this training carried out by students and the self-assessment conducted by the faculty ("trainers").
- Being tested
- Educational simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational simulationOther
| Study group | Role | What they receive |
|---|---|---|
| Student | Not described Receives: Other: Educational simulation | |
| Trainers | Not described Receives: Other: Educational simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SFDP26 questionnaire
This questionnaire is part of the System for Evaluation of Teaching Qualities (SETQ) which includes (1) a self-assessment by the trainer (2) an assessment by the student (3) then a feedback and (4) a follow-up to improve teaching. The SFDP26 questionnaire therefore exists in several versions for an evaluation of training by the students but also for a self-evaluation of by the trainers. Both versions share 25 basic items covering 7 dimensions of teaching quality
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de l'arthrose, Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de la Réunion
- Responsible party
- Principal investigator, Maillot Cédric, Centre de l'arthrose, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957889
- Sponsor's protocol ID
- nurse_pedago
- Status last verified
- May 2019
- First submitted
- 19 May 2019
- Last updated
- 21 May 2019
- Results posted
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Students' and Trainers' Evaluations While Learning Delegated Surgical Procedures: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03957889
- Acronym / sponsor ID
- nurse_pedago
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Centre de l'arthrose, ParisUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de la Réunion
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 21 May 2019 (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 delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing ("students") (2) and to evaluate the correlation between the evaluation of this training carried out by students and the self-assessment conducted by the faculty ("trainers").
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Student | – | Other: Educational simulation |
| Trainers | – | Other: Educational simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We divided Students into groups of 10 to 12 students, distributed into 5 sessions over the study period. We paid attention to mix these groups according to various places of exercise, surgical skills, length of professional practice and sectors of public or private activities. This group allocation was intended to enrich the exchanges between students by providing diverse personal and professional experiences, while maintaining a balance between the groups.
Key inclusion criteria (2 listed)
- scrub nurses already in practice
- professional trainer, specialist in the field of the proposed course subject
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 |
|---|---|---|
| Educational simulation | Other | Student, Trainers |
Primary outcome
SFDP26 questionnaire
Time frame: 2 weeks
This questionnaire is part of the System for Evaluation of Teaching Qualities (SETQ) which includes (1) a self-assessment by the trainer (2) an assessment by the student (3) then a feedback and (4) a follow-up to improve teaching. The SFDP26 questionnaire therefore exists in several versions for an evaluation of training by the students but also for a self-evaluation of by the trainers. Both versions share 25 basic items covering 7 dimensions of teaching quality
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 21 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedure, Unspecified and Critical Thinking, run by Centre de l'arthrose, Paris.
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 2 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: finished, as of the sponsor's last update on 21 May 2019. 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?
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?
SFDP26 questionnaire (time frame: 2 weeks). 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 21 May 2019.