Conformity, SocialCONF1NCT06664216
Impact of Behavioral Compliance Between Residents and Surgeons
A study testing incorrect trocar placement marks. in people with Conformity, Social, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 1 site in Colombia.
Trial summary
This study aims to evaluate the influence of perceived peer performance on the clinical skill of trocar placement during laparoscopic cholecystectomy among surgeons and surgical residents. It investigates whether exposure to incorrect trocar placements by peers affects the accuracy of subsequent placements. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Conformity, Social
- What is being tested?
- incorrect trocar placement marks.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteColombia
- Study dates
- 7 Aug 2024to 27 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Over 18 years old
- Spanish mother tongue
- Experience in laparoscopic cholecystectomy
- Consent to participate
Who cannot join
- Physical disability preventing understanding or response
- More than 3 years of suspension from surgical practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Behavioral Compliance Between Residents and Surgeons Using a Simulation Environment of Trocar Placement in Laparoscopic Cholecystectomy
This study aims to evaluate the influence of perceived peer performance on the clinical skill of trocar placement during laparoscopic cholecystectomy among surgeons and surgical residents. It investigates whether exposure to incorrect trocar placements by peers affects the accuracy of subsequent placements.
- Conditions
- Conformity, Social
- Being tested
- incorrect trocar placement marks.
- Keywords
- conformity, groupthinking, surgeons
- Medical subject headings
- Social Conformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incorrect trocar placement marks.Behavioural
Participants in the experimental group will perform trocar placements on laparoscopic models that have been pre-marked with incorrect insertion sites by previous participants. These marks simulate procedural steps or anatomical landmarks that are intentionally incorrect.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants use a laparoscopic model without any previous marks. Receives: Behavioral: incorrect trocar placement marks. |
| Intervention | Experimental | Participants use a laparoscopic model with incorrect trocar placement marks. Receives: Behavioral: incorrect trocar placement marks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the trocar placements
The participant must define in a graphic format the site where the trocars would be placed to perform a laparoscopic cholecystectomy.
The number of trocars correctly placed will be recorded. A rate of will be calculated: Trocars in the correct place/Total number of trocars.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start7 Aug 2024
- Primary completion30 Aug 2024
- Study completion27 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Conformity, SocialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- Asociacion Colombiana de Cirugia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664216
- Sponsor's protocol ID
- 3
- Acronym
- CONF1
- Status last verified
- Oct 2024
- First submitted
- 4 Aug 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cialdini RB, Goldstein NJ. Social influence: compliance and conformity. Annu Rev Psychol. 2004;55:591-621. doi: 10.1146/annurev.psych.55.090902.142015.
PubMed 14744228MILGRAM S. BEHAVIORAL STUDY OF OBEDIENCE. J Abnorm Psychol. 1963 Oct;67:371-8. doi: 10.1037/h0040525. No abstract available.
PubMed 14049516Kass LR. Ethical dilemmas in the care of the ill. I. What is the physician's service? JAMA. 1980 Oct 17;244(16):1811-6.
PubMed 7420682Tobin B. Respect for conscientious judgement in health care. J Paediatr Child Health. 2022 Oct;58(10):1729-1730. doi: 10.1111/jpc.16211. Epub 2022 Sep 13. No abstract available.
PubMed 36098673Genuis SJ, Lipp C. Ethical diversity and the role of conscience in clinical medicine. Int J Family Med. 2013;2013:587541. doi: 10.1155/2013/587541. Epub 2013 Dec 12.
PubMed 24455248Lehmann LS, Sulmasy LS, Desai S; ACP Ethics, Professionalism and Human Rights Committee. Hidden Curricula, Ethics, and Professionalism: Optimizing Clinical Learning Environments in Becoming and Being a Physician: A Position Paper of the American College of Physicians. Ann Intern Med. 2018 Apr 3;168(7):506-508. doi: 10.7326/M17-2058. Epub 2018 Feb 27.
PubMed 29482210Beran TN, Altabbaa G, Oddone Paolucci E. Observational Study of Conformity in Yet Another Medical Learning Environment: Conformity to Preceptors During High-Fidelity Simulation. Adv Med Educ Pract. 2023 Dec 22;14:1445-1452. doi: 10.2147/AMEP.S427996. eCollection 2023.
PubMed 38149121Beran TN, McLaughlin K, Al Ansari A, Kassam A. Conformity of behaviors among medical students: impact on performance of knee arthrocentesis in simulation. Adv Health Sci Educ Theory Pract. 2013 Oct;18(4):589-96. doi: 10.1007/s10459-012-9397-5. Epub 2012 Aug 31.
PubMed 22936210Beran TN, Kaba A, Caird J, McLaughlin K. The good and bad of group conformity: a call for a new programme of research in medical education. Med Educ. 2014 Sep;48(9):851-9. doi: 10.1111/medu.12510.
PubMed 25113112
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Behavioral Compliance Between Residents and Surgeons Using a Simulation Environment of Trocar Placement in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06664216
- Acronym / sponsor ID
- CONF1 / 3
- Conditions
- Conformity, Social
- Keywords
- conformity, groupthinking, surgeons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- Asociacion Colombiana de Cirugia
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 27 Oct 2024 (actual)
- First posted
- 29 Oct 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 influence of perceived peer performance on the clinical skill of trocar placement during laparoscopic cholecystectomy among surgeons and surgical residents. It investigates whether exposure to incorrect trocar placements by peers affects the accuracy of subsequent placements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: incorrect trocar placement marks.Participants use a laparoscopic model without any previous marks. |
| Intervention | Experimental | Behavioral: incorrect trocar placement marks.Participants use a laparoscopic model with incorrect trocar placement marks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old
- Spanish mother tongue
- Experience in laparoscopic cholecystectomy
- Consent to participate
Key exclusion criteria (2 listed)
- Physical disability preventing understanding or response
- More than 3 years of suspension from surgical practice
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 |
|---|---|---|
| incorrect trocar placement marks.Participants in the experimental group will perform trocar placements on laparoscopic models that have been pre-marked with incorrect insertion sites by previous participants. These marks simulate procedural steps or anatomical landmarks that are intentionally incorrect. | Behavioural | Control, Intervention |
Primary outcome
accuracy of the trocar placements
Time frame: 1 week
The participant must define in a graphic format the site where the trocars would be placed to perform a laparoscopic cholecystectomy. The number of trocars correctly placed will be recorded. A rate of will be calculated: Trocars in the correct place/Total number of trocars.
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 29 Oct 2024.
- Results publication: PubMed 14744228Cialdini RB, Goldstein NJ. Social influence: compliance and conformity. Annu Rev Psychol. 2004;55:591-621. doi: 10.1146/annurev.psych.55.090902.142015.
- Results publication: PubMed 14049516MILGRAM S. BEHAVIORAL STUDY OF OBEDIENCE. J Abnorm Psychol. 1963 Oct;67:371-8. doi: 10.1037/h0040525. No abstract available.
- Results publication: PubMed 7420682Kass LR. Ethical dilemmas in the care of the ill. I. What is the physician's service? JAMA. 1980 Oct 17;244(16):1811-6.
- Results publication: PubMed 36098673Tobin B. Respect for conscientious judgement in health care. J Paediatr Child Health. 2022 Oct;58(10):1729-1730. doi: 10.1111/jpc.16211. Epub 2022 Sep 13. No abstract available.
- Results publication: PubMed 24455248Genuis SJ, Lipp C. Ethical diversity and the role of conscience in clinical medicine. Int J Family Med. 2013;2013:587541. doi: 10.1155/2013/587541. Epub 2013 Dec 12.
- Results publication: PubMed 29482210Lehmann LS, Sulmasy LS, Desai S; ACP Ethics, Professionalism and Human Rights Committee. Hidden Curricula, Ethics, and Professionalism: Optimizing Clinical Learning Environments in Becoming and Being a Physician: A Position Paper of the American College of Physicians. Ann Intern Med. 2018 Apr 3;168(7):506-508. doi: 10.7326/M17-2058. Epub 2018 Feb 27.
- Results publication: PubMed 38149121Beran TN, Altabbaa G, Oddone Paolucci E. Observational Study of Conformity in Yet Another Medical Learning Environment: Conformity to Preceptors During High-Fidelity Simulation. Adv Med Educ Pract. 2023 Dec 22;14:1445-1452. doi: 10.2147/AMEP.S427996. eCollection 2023.
- Results publication: PubMed 22936210Beran TN, McLaughlin K, Al Ansari A, Kassam A. Conformity of behaviors among medical students: impact on performance of knee arthrocentesis in simulation. Adv Health Sci Educ Theory Pract. 2013 Oct;18(4):589-96. doi: 10.1007/s10459-012-9397-5. Epub 2012 Aug 31.
- Results publication: PubMed 25113112Beran TN, Kaba A, Caird J, McLaughlin K. The good and bad of group conformity: a call for a new programme of research in medical education. Med Educ. 2014 Sep;48(9):851-9. doi: 10.1111/medu.12510.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incorrect trocar placement marks. in people with Conformity, Social, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 1 site in Colombia.
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 29 Oct 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 Colombia. 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?
accuracy of the trocar placements (time frame: 1 week). 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 NCT06664216, which also lists 9 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 29 Oct 2024.