跳至主要内容
临床试验/NCT03501641
NCT03501641已完成不适用

A Study of Heart Rate Variability and Cognitive Load on Image-Based Virtual Reality Instructional Design in Otolaryngology

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
direct observation of procedural skills (DOPS)

研究概览

简要总结

This study aims to compare heart rate variation, cognitive load, and learning outcomes of novel image-based virtual reality with traditional video in learning for otolaryngology. Half of participants will receive image-based virtual reality learning, while the other half will receive video-based learning.

详细描述

Background: Workplace-based assessments, such as mini-clinical evaluation exercise (mini-CEX), direct observation of procedural skills (DOPS), and milestones, target the highest level of clinical competence and collect information about doctors' performance in their normal practice. Recent advances in virtual reality (VR) simulation, lowering the complex of learning task and the cognitive load (CL) of the learner, make this novel technology well suited for the initial training of novices. Reduced heart rate variation (HRV), an indicator of stress, is associated with decreased cognitive efficiency in health. Accordingly, this study hypothesizes that VR-based instruction can help novices to increase HRV, decrease CL, and then improve their outcomes of workplace-based assessments.

Aims: This prospective study aims (1) to design an image-based VR (IBVR) instruction for clinical medical education, (2) to compare HRV and CL in traditional video-based (VB) learning and novel IBVR-based learning, (3) to compare outcomes of mini-CEX, DOPS, and milestone between two modules, (4) to perform a qualitative evaluation of IBVR-based learning using a 360-degree video review, and (5) to assess various levels of novice learners (undergraduate medical students and postgraduate year residents) for their participation in and acceptance of this novel IBVR-based learning.

Study Designs: This 3-year study includes two parts: (1) Design a VR-based curriculum including fundamental otolaryngological skills, and (2) Validation of an IBVR-based history taking and physical examination (H&P) learning activity using a blinded randomized, parallel-controlled trial in convenience-sampled novice undergraduate medical students and postgraduate year residents.

Materials and Methods

This study will be implemented between August 1, 2017 and July 30, 2020. Firstly, a VR-based curriculum will be designed including H&P using the analysis, design, development, implementation, and evaluation model and a modified Delphi approach. VB module and IBVR module of the same contexts will be developed. Secondly, an IBVR-based H&P learning activity will be validated by measuring CL questionnaires, reaction time, HRV, mini-CEX, DOPS, milestones, global satisfaction scale and AttrakDiff2 questionnaires (n = 64). Age, sex, and cognitive style (determined by the Group Embedded Figures Test) of both groups are matched. Differences in variables of interests will be statistically analyzed.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Blinding to the purpose of the study during recruitment is maintained to minimize preparation bias. After randomization, the participants are unblinded and use image-based virtual reality model or conventional video-based model on a virtual reality eyeglass in an ordinary office environment for 10 minutes. Heart rate variation will be monitored during learning and cognitive load will be assessed by the participants. Subsequently, each participant will perform history taking and physical examination for a real patient in a teaching clinic. The competence will be evaluated using the mini-clinical evaluation exercise, direct observation of procedural skills (DOPS), and milestone assessments. Investigators and outcome assessors are blinded to their randomization and learning models.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 20 years old;
  • Undergraduate medical students (defined as the last year of medical school training) and postgraduate year residents (defined as the first year after graduation).

排除标准

  • Pregnant, hypertension, recent motion sickness, inner ear infections or claustrophobia, recent surgery, pre-existing binocular vision abnormalities, heart conditions or epileptic symptoms;
  • Declining to participate.

结局指标

主要结局

direct observation of procedural skills (DOPS)

时间窗: DOPS will be assessed immediately after intervention.

Procedural skills of history taking and physical examination for otolaryngology will be evaluated using a DOPS assessment immediately after a 10-minute mini-clinical exercise. This assessment uses ten items (indication, explanation, preparation, sites, aseptic/safe procedure, completeness, request for help, recording, interpretation, and global assessment) with 10 (1-10) Likert scales (range: 10-100).

次要结局

  • Cognitive Load Scale (CLS)(The CLS will be assessed immediately after intervention.)
  • Cognitive Load Component (CLC)(The CLC will be assessed immediately after intervention.)
  • Hedonic Stimulation (HQ-S)(The HQ-S will be assessed immediately after intervention.)
  • Mini-clinical evaluation exercise (mini-CEX)(The mini-CEX will be assessed immediately after intervention.)
  • Global Satisfaction Scale (GSS)(The GSS will be assessed immediately after intervention.)
  • Task Load Index (TLX)(The TLX will be assessed immediately after intervention.)
  • Pragmatic Quality (PQ)(The PQ will be assessed immediately after intervention.)
  • Milestones(The milestones will be assessed immediately after intervention.)
  • Bidirectional feedback and reflection(The bidirectional feedback and reflection will be assessed immediately after intervention.)
  • Hedonic Identification (HQ-I)(The HQ-I will be assessed immediately after intervention.)
  • Attractiveness (ATT)(The ATT will be assessed immediately after intervention.)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验