Effect of Artificial Intelligence-Based Virtual Reality on Patient-Reported Outcomes During Upper Gastrointestinal Endoscopy: A Randomized Controlled Trial

Upper gastrointestinal endoscopy is an important diagnostic and therapeutic procedure; however, patients may experience anxiety, pain, discomfort, and physiological changes before and during the procedure. These experiences may negatively affect patient comfort and satisfaction. This study was designed to evaluate the effect of an artificial intelligence-based virtual reality (AI-VR) relaxation intervention on patient-reported and physiological outcomes among patients undergoing elective upper gastrointestinal endoscopy.

This study uses a randomized controlled trial design. Eligible patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-VR relaxation session immediately before undergoing upper gastrointestinal endoscopy. The control group will receive routine care according to the usual clinical practice.

The AI-VR intervention is intended to provide a relaxation experience before the endoscopic procedure. Patient outcomes will be assessed using validated measures of anxiety and pain, together with physiological parameters and patient satisfaction. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), pain perception will be assessed using the Visual Analog Scale (VAS), and patient satisfaction will be assessed using the Patient Satisfaction Questionnaire (PSQ). Physiological parameters will also be assessed at the prespecified assessment time points.

The primary purpose of the study is to determine whether the AI-VR intervention improves patient outcomes during upper gastrointestinal endoscopy compared with routine care. Outcomes of interest include anxiety level, pain perception, physiological responses, and patient satisfaction.

Randomization will be performed using a computer-generated random sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Eligible participants will be enrolled after confirmation of eligibility and informed consent and will then be assigned to their respective study groups according to the concealed allocation sequence.