- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07650019
EDA-Based Adaptive Support in VR ALS Training
Effects of Electrodermal Activity-Based Adaptive Support Systems on Performance in VR-Based Advanced Life Support Training: A Randomized Controlled Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
This study is a randomized controlled trial designed to evaluate whether an electrodermal activity (EDA)-based adaptive support system can improve performance in VR-based advanced life support (ALS) training. The research focuses on integrating physiological stress monitoring into automated VR simulation systems to create a more responsive and individualized learning environment.
Simulation-based education is widely used in medical training because it enables learners to practice high-risk clinical procedures in a safe and controlled environment. However, most automated VR training systems currently provide standardized instruction regardless of participants' stress levels or individual needs. Since acute stress may negatively influence cognitive and psychomotor performance during complex medical tasks, adaptive systems that dynamically respond to learners' stress may improve educational outcomes.
The study will recruit 72 volunteer second-year anesthesia technician students from Acıbadem Mehmet Ali Aydınlar University. Participants will be randomly assigned to either an adaptive-support condition or a standard-training control condition. Before the experimental phase, all participants will complete a standardized ALS preparatory training and competency assessment to ensure comparable baseline knowledge levels across groups.
During VR-based ALS training, participants' EDA levels will be continuously recorded using a non-invasive physiological monitoring system. Baseline EDA measurements will first be collected during a resting period. In the adaptive-support condition, when a participant's EDA exceeds a predefined threshold indicating elevated stress, the system will automatically activate a support mode. This mode will provide additional guidance, more frequent instructions, and extended response time during the simulation. Participants in the control group will continue the simulation under standard conditions without adaptive modifications.
After completing the training, all participants will undergo the same VR-based performance examination without guidance. Performance will be automatically evaluated by the simulation system. In addition to performance outcomes, participants will complete self-report measures assessing presence, state and trait anxiety, social anxiety, and personality traits. These measures will allow the researchers to investigate how individual differences influence stress responses, presence experiences, and training outcomes in adaptive VR environments.
The findings of this study are expected to contribute to the development of more flexible, personalized, and physiologically responsive VR-based medical training systems. The project may also provide empirical evidence for integrating real-time psychophysiological monitoring into automated simulation-based education.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Being older than 18
Exclusion Criteria:
- prior completion of ALS training
- history of virtual reality (VR)-induced motion sickness
- medical conditions such as vertigo or the use of medications known to cause vertigo-like symptoms
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Adaptive Support
Participants in this arm will receive VR-based advanced life support training with an electrodermal activity (EDA)-based adaptive support system.
During the simulation, participants' stress levels will be continuously monitored using EDA measurements.
When stress exceeds a predefined threshold, the system will automatically activate a support mode that provides additional guidance, more frequent instructions, and extended response time.
|
Participants receive VR-based advanced life support training with an electrodermal activity (EDA)-based adaptive support system that automatically provides additional guidance, more frequent instructions, and extended response time when stress levels exceed a predefined threshold.
|
|
Experimental: Standard Training
Participants in this arm will receive standard VR-based advanced life support training without adaptive support.
Although electrodermal activity (EDA) will be recorded throughout the simulation, the training flow will remain unchanged regardless of participants' stress levels, and no additional guidance or time adjustments will be provided.
|
Participants receive standard VR-based advanced life support training without adaptive support.
Although electrodermal activity (EDA) is monitored during the simulation, the training flow remains unchanged regardless of stress levels.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Advanced Life Support Performance Score
Zeitfenster: Up to 4 weeks
|
Participants' performance during the post-training VR-based advanced life support examination will be automatically evaluated by the simulation system.
The score will reflect the accuracy and completeness of advanced life support procedures performed without guidance.
|
Up to 4 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Electrodermal Activity (EDA) Level
Zeitfenster: Up to 4 weeks
|
Description: Participants' physiological stress responses during the VR simulation will be continuously measured using electrodermal activity recordings. Baseline and training-phase EDA values will be analyzed. |
Up to 4 weeks
|
|
Presence Score
Zeitfenster: Up to 4 weeks
|
Participants' sense of presence in the VR environment will be assessed using the Turkish adaptation of the Presence Questionnaire developed by Witmer and Singer (1998).
Higher scores indicate a stronger sense of immersion and realism in the virtual environment.
|
Up to 4 weeks
|
|
State Anxiety Score
Zeitfenster: Up to 4 weeks
|
articipants' situational anxiety levels following the VR training will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI).
|
Up to 4 weeks
|
|
Trait Anxiety Score
Zeitfenster: Up to 4 weeks
|
Participants' general tendency toward anxiety will be assessed using the Trait Anxiety subscale of the State-Trait Anxiety Inventory (STAI).
|
Up to 4 weeks
|
|
Social Anxiety Score
Zeitfenster: Up to 4 weeks
|
Participants' social anxiety levels will be assessed using the Liebowitz Social Anxiety Scale, which evaluates anxiety and avoidance in social and performance situations.
|
Up to 4 weeks
|
|
Personality Traits
Zeitfenster: Up to 4 weeks
|
Participants' personality characteristics will be assessed using the Ten-Item Personality Inventory, which measures extraversion, agreeableness, conscientiousness, emotional stability, and openness to experience.
|
Up to 4 weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2026-06/269
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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