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临床试验/NCT07361913
NCT07361913尚未招募不适用

A Multicentre, Randomised Cross-over Equivalence Trial Investigating Knowledge of Anatomy Following Virtual Reality or Standard Teaching in Novice Anaesthetists

Royal National Orthopaedic Hospital NHS Trust0 个研究点目标入组 102 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
主要终点
Score out of 44 on a validated test of anatomy and sono-anatomy

研究概览

简要总结

Primary Objective: Score out of 44 on a validated test of anatomy and sono-anatomy

Secondary Objective:

Before training

  • Handedness (Edinburgh Handedness Inventory)
  • Subjective sleepiness (Karolinska scale)
  • Motor reaction time (Psychomotor Vigilance test)
  • Attention control (Anti-Saccade test)
  • Mental rotation (Mental Rotation Task)
  • Depression Anxiety, Stress (DASS score)
  • Visual Search Task (Divided Attention)
  • Knowledge pretraining

After training and testing

  • Knowledge after training session
  • Acceptability: Client Satisfaction Questionnaire (CSQ-8)
  • Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR)
  • Immersion: Witmer and Singer Presence Questionnaire
  • Subjective workload (NASA - TLX scale)
  • Cognitive Demand Battery (CBD)
  • Resource use: Calculation of cost differences between learning Modalities

Study population: Resident anaesthetists

Recruitment Target: 102

Methodology:

This is a non-clinical randomised controlled trial of resident anaesthetists undergoing training in regional anaesthesia. Residents will be randomised to one of two groups for each training session day:

  • Standard anatomical training (Group A)
  • Virtual reality based anatomical training. (Group B) Then followed by another training day session and participants will enter either standard or VR teaching depending on the previous allocation:
  • Standard anatomical training (Group B)
  • Virtual reality based anatomical training. (Group A)

Anatomical knowledge will be tested in both groups using an on-line questionnaire developed by the Chief Investigator.

Eligibility criteria: Inclusion criteria:

  1. Anaesthetists that are residents in a recognised Royal College of Anaesthetists (RCoA) training program
  2. Anaesthetic training grades (Stage 1 - 3).

Exclusion criteria:

  1. Visual impairment (this does not include wearing glasses/contact lenses)
  2. History of severe diseases affecting physical motion or balance
  3. History of any drugs that may affect physical motion or balance within 12 hours of the intervention
  4. Pregnancy
  5. Individuals who had consumed alcohol within 24 h of the intervention.
  6. Resident doctors not in a recognised RCOA training program e.g. Staff grade anaesthetists.

Study treatment:

Standard teaching - control Virtual reality teaching - intervention

详细描述

STUDY RATIONALE AND RISK/BENEFIT ANALYSIS We propose that in order to develop a sound knowledge of anatomy and sono-antomy, virtual reality could be used as an aid to understanding and interpreting 2-D sono-antomical structures. Trainees will have an enhanced learning experience that reinforces the skills required to perform safe regional anaesthesia.

Hypothesis: We hypothesise that knowledge of regional nerve anatomy among novice anaesthetists using 3D virtual reality is equivalent to standard teaching.

MANAGEMENT OF POTENTIAL STUDY RISKS One potential major weakness is the risk of trainer bias when delivering training. The knowledge test was written by Dr Bellew, and that Dr Bellew and Prof McLeod will be delivering the 'VR training' and 'standard training' arms respectively. The possibility exists for the trainers to bias results by providing test-specific training to one arm, but not the other. To mitigate this risk training packages with specific anatomical areas taught and check lists will be used by an observer to ensure all aspects are taught and/or omitted as per the training package.

Virtual reality is usually regarded as safe to use. There are reports of it causing headache, eyestrain, fatigue, blurred vision and dizziness with prolonged use. These symptoms tend to get better shortly after participants stop using the virtual reality equipment. We will minimise the risk of these symptoms by limiting the use of the virtual reality headset to 2 - 3 x 30-40 minute sessions within an eight-hour period. We will be assessing for these side effects using validated questionnaires. Also, the VR environment will be projected onto a screen for participants if they need to remove the VR equipment.

PRIMARY OBJECTIVE Our primary aim is to study knowledge of anatomy following initial VR teaching compared to standard teaching.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Masking Description

入排标准

性别
All
接受健康志愿者

入选标准

  • Anaesthetists that are residents in a recognised Royal College of Anaesthetists (RCoA) training program
  • Anaesthetic training grades (Stage 1 - 3).

排除标准

  • Visual impairment (this does not include wearing glasses/contact lenses)
  • History of severe diseases affecting physical motion or balance
  • History of any drugs that may affect physical motion or balance within 12 hours of the intervention
  • Pregnancy
  • Individuals who had consumed alcohol within 24 h of the intervention.
  • Resident doctors not in a recognised RCOA training program e.g. Staff grade anaesthetists

研究组 & 干预措施

Standard teaching

Active Comparator

Standard anatomical training

干预措施: Standard anatomy model teaching (Other)

Virtual reality

Experimental

Virtual reality based anatomical training

干预措施: 3D virtual reality anatomy teaching (Other)

结局指标

主要结局

Score out of 44 on a validated test of anatomy and sono-anatomy

时间窗: From enrolement to end of study day 2

Sonoanatomy knowledge using Virtual Reality

次要结局

  • Handedness (Edinburgh Handedness Inventory)(2 - 4 weeks prior to study day 1)
  • Visual Search Task (Divided Attention)(2 - 4 weeks prior to study day 1)

研究者

发起方
Royal National Orthopaedic Hospital NHS Trust
申办方类型
Other
责任方
Sponsor

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