Recruiting

NCT Number: NCT06917755

The Impact of Immersive Virtual Reality Training in Thyroid Surgery

Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.

Investigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.

Training superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.

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Key information

Conditions

Virtual Reality Simulation Thyroid Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Georgios Gennimatas" General Hospital of Thessaloniki

Thessaloniki, 54635, Greece

Location status: Recruiting

Location contact

Giannis Koutelidakis, Professor of Surgery

CONTACT

[email protected]

+306944697077

Nikolaos Voloudakis, Academic Fellow

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
Residents who have completed their 1st year of training programm.

Exclusion criteria

Disagreement of participants' randomisation
Prolonged surgical time of completion
Participant's experience beyond the included limits
Participants who are completely incapable of using VR devices or have specific helath restrictions of using these
Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter

Treatment and study plan

Virtual Reality Training in Thyroid Surgery

Other

Participants will use an application in an Immersive Virtual Reality environment. In this module, the participant will be the chief surgeon and will be guided to accomplise the first steps of thyroidectomy: from neck incision until continious neuromonitoring device placement in vagus nerve.

Convetional Training

Other

This intervation consists of traditional methods of training. Participants will read specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, they will be provided with videos of the clinic's archive which will support them with specific surgical steps : neck incision up to Continious Neuromonitoring Device placement on Vagus nerve.

Primary outcomes

OSATS Score

Time frame: From enrollment to the end of assesment of the FEBS certicied surgeon at 1 day

As the Primary Outcome Measure of the study will be the OSATS(Objective Structured Assessment of Technical Skills) score of participants in each group. Statistical significance of this score between groups will be measured.OSATS is a worlwide tool which measure surgical performance using 7 measurements and scoring system from 7 to 35. Its main advantage is that can measure with a quantitative manner surgical performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Nikolaos Voloudakis, Academic Fellow

CONTACT

[email protected]

+306947200452

Stefanos Atmatzidis, Assistant Professor of Surgery

CONTACT

[email protected]

+306977095756

Sponsors and collaborators

Lead sponsor

G.Gennimatas General Hospital

Other

Registry information

Official study title

The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 8, 2025
Registry last updated: Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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