The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty.
The main questions it aims to answer are:
* What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)? * What potential adverse effects are associated with the use of virtual reality in the postoperative context? * What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management? * How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?
Adults ≥18 years of age, both sexes
Scheduled unilateral knee arthroplasty
Adequate cognitive and functional capacity to use virtual reality
Signed informed consent
Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis, schizophrenia, claustrophobia, tremor, rigidity)
Significant visual or hearing impairments that hinder VR use
Physical or motor limitations preventing the use of VR headsets or maintaining the required posture
Score ≥4 on the 4AT delirium screening tool
Parallel
VIRTUAL REALITY
DeviceInteractive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios: * Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment. * Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task. * Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles. Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music).
Pain intensity (VAS)
Pain intensity is assessed using a 100-mm Visual Analogue Scale (VAS), ranging from "no pain" (0 mm, left anchor) to "worst imaginable pain" (100 mm, right anchor). Higher scores indicate greater pain intensity.
Sociodemographic variables
Age, weight, sex, and height recorded at enrollment
Analgesic medication use
Analgesic administration (scheduled analgesia and rescue medication) is extracted from the hospital electronic medical record (Selene). Date and time of each dose are recorded to determine whether the intervention reduces short-term analgesic requirements.
Adverse events
All adverse events reported by participants or investigators are documented and classified by intensity ("mild," "moderate," "severe") and by relatedness to the intervention ("none," "unlikely," "possible," "definite")
Satisfaction, Acceptability, and Perceived Safety (SEQ)
The Suitability Evaluation Questionnaire (SEQ) assesses satisfaction, acceptability, usability, and perceived safety of the VR system. It includes 13 items rated from 1 ("not at all" or "very easy") to 5 ("very much" or "very difficult"), plus one open-ended question on discomfort
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Universidad Francisco de Vitoria
Lead sponsor
University of Castilla-La Mancha
Collaborator
Hospital Universitario del Sureste
Collaborator
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