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Completed

NCT Number: NCT03501641

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

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.

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Key information

Conditions

Cognitive Function 1, Social Arrhythmias, Cardiac Behavior Cardiac Conduction System Disease Cardiovascular Diseases Competence Heart Diseases Heart Rate Fast Learning, Spatial Otolaryngologic Disorder Pathologic Processes Pathological Conditions, Signs and Symptoms Spatial Behavior Spatial Learning Tachycardia

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linkou Chang Gung Memorial Hospital

Taoyuan City, 33305, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

image-based virtual reality learning

Other

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

Other

voice of the staffs and standard patients.

Primary outcomes

  1. direct observation of procedural skills (DOPS)

    Time frame: 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).

Secondary outcomes

  1. Mini-clinical evaluation exercise (mini-CEX)

    Time frame: The mini-CEX will be assessed immediately after intervention.

    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).

  2. Milestones

    Time frame: The milestones will be assessed immediately after intervention.

    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).

  3. Cognitive Load Scale (CLS)

    Time frame: The CLS will be assessed immediately after intervention.

    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).

  4. Task Load Index (TLX)

    Time frame: The TLX will be assessed immediately after intervention.

    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).

  5. Cognitive Load Component (CLC)

    Time frame: The CLC will be assessed immediately after intervention.

    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).

  6. Bidirectional feedback and reflection

    Time frame: The bidirectional feedback and reflection will be assessed immediately after intervention.

    Bidirectional feedback and reflection will be immediate evaluated using a qualitative questionnaire after an intervention.

  7. Global Satisfaction Scale (GSS)

    Time frame: The GSS will be assessed immediately after intervention.

    Global satisfaction of the specific intervention will be immediately evaluated using the GSS questionnaire with 11 Likert scales (range: 0-10) after an intervention.

  8. Pragmatic Quality (PQ)

    Time frame: The PQ will be assessed immediately after intervention.

    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.

  9. Hedonic Stimulation (HQ-S)

    Time frame: The HQ-S will be assessed immediately after intervention.

    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.

  10. Hedonic Identification (HQ-I)

    Time frame: The HQ-I will be assessed immediately after intervention.

    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.

  11. Attractiveness (ATT)

    Time frame: The ATT will be assessed immediately after intervention.

    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.

Other outcomes

  1. Heart Rate Variation

    Time frame: At baseline for 2 minutes and during an intervention for 10 minutes.

    Before and during an intervention, heart rate is continuously recorded. Heart rate variations will be calculated at baseline and during the specific intervention.

  2. Reaction time

    Time frame: At baseline, the 5th minute and the 10th time.

    The dual-task paradigm with reaction time measurement is manually measured (seconds).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 18, 2018
Registry last updated
Feb 1, 2021

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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