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

Cognitive Function 1, Social Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03501641
• Other study ID #: 201601821B0
• Status: Completed
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age > 20 years old;

2. Undergraduate medical students (defined as the last year of medical school training) and postgraduate year residents (defined as the first year after graduation).

Exclusion Criteria:

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

2. Declining to participate.

Related Conditions & MeSH terms

• Cognitive Function 1, Social
• Competence
• Heart Rate Fast
• Learning, Spatial
• Otolaryngologic Disorder
• Tachycardia

Intervention

Other:
• image-based virtual reality learning
The participants will use a whole-view, 360 degree image-based virtual reality to learn a competence of history taking and physical examination for otolaryngology and they can see the response of the staffs and standard patients (including image, voice, face expression, movement, ... etc).
• video-based learning
voice of the staffs and standard patients.

Locations

Country	Name	City	State
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate Variation	Before and during an intervention, heart rate is continuously recorded. Heart rate variations will be calculated at baseline and during the specific intervention.	At baseline for 2 minutes and during an intervention for 10 minutes.
Other	Reaction time	The dual-task paradigm with reaction time measurement is manually measured (seconds).	At baseline, the 5th minute and the 10th time.
Primary	direct observation of procedural skills (DOPS)	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).	DOPS will be assessed immediately after intervention.
Secondary	Mini-clinical evaluation exercise (mini-CEX)	Skills of history taking and physical examination for otolaryngology will be evaluated using a mini-CEX assessment immediately after a mini-clinical exercise. The Mini-CEX is a 10-minute direct observation assessment. This assessment uses seven items (interview, physical examination, professionalism, clinical diagnosis, explanation, efficiency, and global assessment) with 9 (1-9) Likert scales (range: 7-63).	The mini-CEX will be assessed immediately after intervention.
Secondary	Milestones	Overall competence of history taking and physical examination for otolaryngology will be immediately evaluated using an assessment of milestones after a 10-minute mini-clinical exercise. This assessment uses five Likert-type levels (basic, focuses, appropriate, accurate, professional) (range: 1-5).	The milestones will be assessed immediately after intervention.
Secondary	Cognitive Load Scale (CLS)	Cognitive load of the specific intervention will be immediately evaluated using the Paas CLS questionnaire after an intervention. The Paas CLS questionnaire is a single-item measure of total cognitive load. Participants are asked to rate the perceived intensity of their mental effort with 9 Likert scales (1 = very, very low mental effort; 9 = very, very high mental effort).	The CLS will be assessed immediately after intervention.
Secondary	Task Load Index (TLX)	Task Load of the specific intervention will be evaluated using the National Aeronautics and Space Administration TLX questionnaire after an intervention. The questionnaire has six subscales: mental demand; physical demand; temporal demand; performance; effort, and frustration. Participants are asked to indicate the level of each dimension by making a mark on a visual analogue scale with a 21-point Likert scale (range: 0-20). Total cognitive load is interpreted as the sum of the six subscales (range: 0-120).	The TLX will be assessed immediately after intervention.
Secondary	Cognitive Load Component (CLC)	Component of cognitive load of the specific intervention will be immediately evaluated using the CLC questionnaire after an intervention. The CLC questionnaire has six subscales: difficulty, complexity, clarity, relevance, focus, and learning with 5 Likert scales (range: 6-30).	The CLC will be assessed immediately after intervention.
Secondary	Bidirectional feedback and reflection	Bidirectional feedback and reflection will be immediate evaluated using a qualitative questionnaire after an intervention.	The bidirectional feedback and reflection will be assessed immediately after intervention.
Secondary	Global Satisfaction Scale (GSS)	Global satisfaction of the specific intervention will be immediately evaluated using the GSS questionnaire with 11 Likert scales (range: 0-10) after an intervention.	The GSS will be assessed immediately after intervention.
Secondary	Pragmatic Quality (PQ)	PQ of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A PQ scale ranges from -3 to 3.	The PQ will be assessed immediately after intervention.
Secondary	Hedonic Stimulation (HQ-S)	HQ-S of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-S scale ranges from -3 to 3.	The HQ-S will be assessed immediately after intervention.
Secondary	Hedonic Identification (HQ-I)	HQ-I of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A HQ-I scale ranges from -3 to 3.	The HQ-I will be assessed immediately after intervention.
Secondary	Attractiveness (ATT)	ATT of the specific intervention will be immediately evaluated using the AttrakDiff2 questionnaire after an intervention. The AttrakDiff2 questionnaire contains 28 questions with 7 Likert-type scales. A ATT scale ranges from -3 to 3.	The ATT will be assessed immediately after intervention.