ClinicalTrials.gg
CompletedNCT07608315PBLUpdated May 27, 2026

AI-Assisted Adaptive Simulation in Physiology Education

An interventional study of AI-Assisted Algorithm-Supported Adaptive Simulation and Conventional Physiology Instruction in Physiology Education, Simulation-Based Learning and v, sponsored by Saveetha University. Completed at 1 site in India. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Saveetha University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2025, registered May 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
672
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

This randomized controlled trial evaluated whether an AI-assisted, rule-based adaptive screen-based simulation module could improve physiology learning outcomes among undergraduate health science students compared with conventional instruction. A total of 672 students from Physiotherapy, Occupational Therapy, Nursing, and Allied Health Sciences were randomly assigned in a 1:1 ratio to either the adaptive simulation group or the conventional teaching group. The intervention used web-based clinical physiology cases with algorithm-supported case sequencing, automated formative feedback, and structured faculty-led debriefing, while the control group received standard lectures, textbook reading, tutorial sessions, and laboratory practicals. The primary outcomes were physiological knowledge and reasoning ability, and the secondary outcomes were conceptual understanding, engagement, cognitive load, and academic self-efficacy. Assessments were performed at baseline, immediately after the 12-week intervention, and again at four-week follow-up.

Read the detailed description

This study was designed as a prospective, two-arm, parallel-group randomized controlled trial with repeated-measures assessment at three time points: baseline, immediately post-intervention, and four weeks after the intervention. It was conducted at Saveetha Institute of Basic Medical Sciences, India, between August 2025 and January 2026, and received institutional ethical approval before enrollment. Participants were undergraduate health science students aged 18 to 25 years who were enrolled in a Human Physiology course and had access to an internet-enabled personal device. Students with prior formal exposure to simulation-based physiology instruction or adaptive digital learning platforms were excluded. After baseline assessment, participants were randomized in a 1:1 ratio to the intervention or control group, with allocation concealment and blinded outcome assessment.

The intervention group received physiology instruction through a screen-based adaptive simulation environment over 12 weeks. The module was intentionally designed as a bundled educational strategy integrating adaptive case sequencing, automated formative feedback, and faculty-led debriefing. The adaptive component used predefined rule-based logic to personalize learning by adjusting case difficulty and feedback pathways according to learner performance; it did not use autonomous generative artificial intelligence or clinical decision-making. Participants completed structured simulation sessions for two hours per week, including pre-briefing, individual case-based simulation, and facilitated debriefing. The control group received conventional curriculum-based physiology instruction over the same 12-week period, including didactic lectures, prescribed textbook readings, tutorial sessions, and laboratory practicals.

The study prioritized objective learning outcomes. Physiological knowledge was measured using a 40-item multiple-choice test, physiological reasoning ability using a scenario-based rubric-scored assessment, and conceptual understanding using a physiology concept inventory. Secondary outcomes included student engagement measured with the USEI, cognitive load measured with NASA-TLX, and academic self-efficacy measured with an adapted CASES scale. Outcomes were collected at baseline, post-intervention, and follow-up using the same instruments across all time points.

02

Conditions studied

  • Physiology Education
  • Simulation-Based Learning
  • v
  • Artificial Intelligence in Education
  • Health Professions Education

Keywords

  • AI-assisted adaptive simulation
  • Screen-based simulation
  • Physiology learning
  • Clinical reasoning
  • Educational technology
  • Undergraduate health sciences
  • Cognitive load
03

In context

Lead sponsor

Saveetha University is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Undergraduate students enrolled in Health Science programs including Physiotherapy, Occupational Therapy, Nursing, and Allied Health Sciences
  • Registered for a Human Physiology course during the study period
  • Age between 18 and 25 years
  • Proficiency in English language
  • Access to an internet-enabled personal device capable of supporting web-based educational applications
  • Willingness to provide written for participation

Exclusion criteria

Exclusion Criteria:

  • Prior formal exposure to structured simulation-based physiology instruction
  • Prior exposure to adaptive digital learning platforms related to physiology education
  • Inability to access or use internet-enabled educational applications required for the intervention
  • Declined or withdrew for participation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
672 participants (actual)

Study arms

  • Experimental
    I-Assisted Adaptive Simulation Group

    Participants received AI-assisted algorithm-supported adaptive screen-based physiology simulation over a 12-week period. The intervention included adaptive case sequencing, automated formative feedback, interactive clinical reasoning activities, animated physiological visualization, and structured faculty-led debriefing sessions aligned with physiology curriculum objectives.

    Behavioral: AI-Assisted Algorithm-Supported Adaptive Simulation

  • Active comparator
    Conventional Instruction Group

    Participants received standard curriculum-based physiology instruction over a 12-week period, including didactic lectures, prescribed textbook readings, faculty-guided tutorial sessions, and scheduled laboratory practicals covering core physiological systems.

    Behavioral: Conventional Physiology Instruction

Interventions

  • BehavioralAI-Assisted Algorithm-Supported Adaptive Simulation

    The intervention consisted of an AI-assisted algorithm-supported adaptive screen-based physiology simulation delivered over 12 weeks. Participants engaged in structured web-based simulation sessions involving interactive clinical case scenarios, animated physiological visualizations, adaptive case sequencing, automated formative feedback, and faculty-led debriefing. The adaptive instructional system operated through predefined rule-based educational algorithms that adjusted case difficulty, feedback pathways, and learning progression according to participant performance within faculty-defined parameters. Sessions included pre-briefing, individual simulation-based clinical reasoning activities, adaptive feedback, and reflective debriefing. The intervention was implemented in alignment with the INACSL Healthcare Simulation Standards of Best Practice and focused on improving physiological knowledge, conceptual understanding, and clinical reasoning skills.

    Also known as: Adaptive Screen-Based Simulation, AI-Assisted Adaptive Simulation, Rule-Based Adaptive Simulation, Adaptive Physiology Simulation Platform

  • BehavioralConventional Physiology Instruction

    Participants received standard curriculum-based physiology instruction over a 12-week period according to institutional teaching guidelines. Conventional instruction included didactic lectures, prescribed textbook readings, faculty-guided tutorial sessions, and scheduled laboratory practicals covering cardiovascular, respiratory, renal, neurological, endocrine, gastrointestinal, musculoskeletal, and integumentary physiology. Tutorial sessions focused on instructor-led clarification of physiological concepts, small-group discussion, and question-and-answer interactions. Laboratory practicals included supervised physiological measurements, observation of physiological demonstrations, interpretation of experimental findings, and guided analysis of physiological responses. The control condition did not include adaptive simulation, automated formative feedback, algorithm-supported instructional adaptation, or structured simulation-based clinical reasoning activities.

    Also known as: Standard Curriculum-Based Teaching, Conventional Teaching, Didactic Physiology Education, Traditional Physiology Instruction

06

What researchers measure

Primary outcomes

  1. Physiological Reasoning Ability

    Physiological reasoning ability was assessed using a scenario-based assessment requiring hypothesis generation, interpretation of physiological data, and application of physiological mechanisms to management decisions. Responses were scored using a standardized four-point analytic rubric assessing reasoning and clinical interpretation skills. Higher scores indicate better physiological reasoning ability.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

  2. Physiological Knowledge

    Physiological knowledge was assessed using a faculty-developed 40-item multiple-choice assessment designed to evaluate conceptual understanding and applied physiological reasoning across eight core physiological systems, including cardiovascular, respiratory, renal, neurological, endocrine, gastrointestinal, musculoskeletal, and integumentary physiology. Higher scores indicate better physiology knowledge performance.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

  3. Conceptual Understanding

    Conceptual understanding was assessed using a faculty-developed Physiology Concept Inventory designed to evaluate deep conceptual understanding, integration of physiological mechanisms across systems, and identification of common physiological misconceptions. Higher scores indicate better conceptual understanding of physiology concepts.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

Secondary outcomes

  1. Student Engagement

    Student engagement was assessed using the University Student Engagement Inventory (USEI), which evaluates behavioral, emotional, and cognitive dimensions of learner engagement. Higher scores indicate greater learner engagement during physiology learning activities.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

  2. Cognitive Load

    Cognitive load was assessed using the NASA Task Load Index (NASA-TLX), a multidimensional measure evaluating perceived cognitive workload and task demand during learning activities. Higher scores indicate greater perceived cognitive workload.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

  3. Academic Self-Efficacy

    Academic self-efficacy was measured using an adapted version of the College Academic Self-Efficacy Scale (CASES) to evaluate learner confidence in physiology-related academic tasks and simulation-based learning activities. Higher scores indicate greater academic self-efficacy.

    Time frame: Baseline (Week 1), post-intervention (Week 13), and follow-up (Week 17)

07

Study locations

1 site
  • Saveetha Institute of Basic Medical Sciences (SIBMS), Saveetha Institute of Medical and Technical Sciences (SIMATS)
    Chennai, Tamil Nadu 602105, India
08

References and documents

Publications

  • Sim JJM, Rusli KDB, Seah B, Levett-Jones T, Lau Y, Liaw SY. Virtual Simulation to Enhance Clinical Reasoning in Nursing: A Systematic Review and Meta-analysis. Clin Simul Nurs. 2022 Aug;69:26-39. doi: 10.1016/j.ecns.2022.05.006. Epub 2022 Jun 15. PubMed 35754937 ↗
  • Elven M, Welin E, Wiegleb Edstrom D, Petreski T, Szopa M, Durning SJ, Edelbring S. Clinical Reasoning Curricula in Health Professions Education: A Scoping Review. J Med Educ Curric Dev. 2023 Oct 25;10:23821205231209093. doi: 10.1177/23821205231209093. eCollection 2023 Jan-Dec. PubMed 37900617 ↗
  • Parodis I, Andersson L, Durning SJ, Hege I, Knez J, Kononowicz AA, Lidskog M, Petreski T, Szopa M, Edelbring S. Clinical Reasoning Needs to Be Explicitly Addressed in Health Professions Curricula: Recommendations from a European Consortium. Int J Environ Res Public Health. 2021 Oct 25;18(21):11202. doi: 10.3390/ijerph182111202. PubMed 34769721 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared because the dataset contains institution-linked educational performance information and participant-level academic assessment data. De-identified data may be considered for academic collaboration upon reasonable request to the corresponding author, subject to institutional ethical approval and data-sharing regulations.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2025 to primary completion in Jan 2026, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2026
First posted
May 27, 2026
StartActual
Aug 1, 2025
Primary completionActual
Jan 31, 2026
CompletionActual
Jan 31, 2026
Last update
May 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07608315
Lead sponsor
Saveetha University
Responsible party
Jeevarathinam Thirumalai (Principal Investigator, Saveetha University) — Principal investigator
First posted
May 27, 2026
Start date
Aug 1, 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026
Last update
May 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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