The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- OSATS Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki
- •Residents who have completed their 1st year of training programm.
排除标准
- •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
研究组 & 干预措施
Control Group
This group will be trained via traditional methods which consists of reading specific chapters of a technical book specialised in Endocrine Surgery (Atlas of Thyroid Surgery- Alexander Shifrin). Also, this group 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.
干预措施: Convetional Training (Other)
Virtual Reality Group
Participants of this group will be provided with a VR device- MetaQuest3- with an application which will guide them to completion of specific surgical steps from incision up to Continious Neuromonitoring Device placement on Vagus nerve.
干预措施: Virtual Reality Training in Thyroid Surgery (Other)
结局指标
主要结局
OSATS Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Anestis Basios
Principal Investigator, Anestis Basios
G.Gennimatas General Hospital