Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Device: VIRTUAL REALITY

Detailed Description

A single-blind, randomized controlled trial will be conducted to compare gaming, 360° video viewing, and usual care interventions. Participants will be recruited from the prehabilitation clinic at Hospital del Sureste (Arganda del Rey), and the study will follow the CONSORT guidelines for clinical crossover and parallel trials.

Three experimental groups will be tested, with interventions performed at three different time points during hospitalization, each session lasting between 10 and 30 minutes. The gaming group will play video games, the control group will view 360° videos, and the usual care group will receive standard analgesia according to the protocol.

Outcome measures will be assessed at baseline (3 months before the intervention), during the intervention, and 1 month after the intervention.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jara María Esteban Sopeña, PhD Student; Phone Number: 1665 913 24 80 64; Email: jaramaria.esteban@ufv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥18 years of age, both sexes
• Scheduled unilateral knee arthroplasty
• Adequate cognitive and functional capacity to use virtual reality
• Signed informed consent

Exclusion Criteria:

• 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
• Pregnancy
• Recreational drug or alcohol use
• Inability to complete the intervention protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: CONTROL; CONVENTIONAL TREATMENT
Experimental: EXPERIMENTAL; VR GAMES	Device: VIRTUAL REALITY; Interactive 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).
Placebo Comparator: PLACEBO; VR VIDEOS 360º	Device: VIRTUAL REALITY; Interactive 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 (day of intervention): pain measured at arrival to the ward and during three shifts (morning, afternoon, next-day morning), pre- and post conventional analgesia. If VR is used, pain is also measured immediately before and after each VR session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic variables	Age, weight, sex, and height recorded at enrollment	Baseline
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.	From immediate postoperative period to 48 hours post-intervention.
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")	Throughout the intervention period and up to 48 hours post-intervention.
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	Immediately post-intervention
Health-Related Quality of Life (EQ-5D-5L)	The EQ-5D-5L assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level severity scale. Provides an individual health profile and utility index	Baseline and 1-month follow-up during outpatient visit
Anxiety and depression (Goldberg Anxiety and Depression Scale)	The Goldberg Scale screens symptoms of anxiety and depression to explore changes associated with the intervention.	Baseline and 1-month follow-up during outpatient visit
Physical Activity Level (IPAQ)	The International Physical Activity Questionnaire (IPAQ) assesses duration, frequency, and intensity of physical activity in the previous week, categorizing participants into low, moderate, or high activity levels.	Baseline and 1-month follow-up during outpatient visit

Collaborators and Investigators

• Sponsor: Universidad Francisco de Vitoria
• Collaborators: University of Castilla-La Mancha; Hospital Universitario del Sureste

Study record dates

Study Major Dates

• Study Start (Estimated): December 27, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: acute pain; virtual reality; postoperative pain; knee arthroplasty
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: PI 94/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No