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

NCT07286084 | Not Yet Recruiting

• 1 other identifier: PI 94/25
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Knee Arthroplasty

Keywords

knee arthroplasty; postoperative pain; acute pain; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Sociodemographic variables

  Baseline

• Analgesic medication use

  From immediate postoperative period to 48 hours post-intervention.

• Adverse events

  Throughout the intervention period and up to 48 hours post-intervention.

• Satisfaction, Acceptability, and Perceived Safety (SEQ)

  Immediately post-intervention

• Health-Related Quality of Life (EQ-5D-5L)

  Baseline and 1-month follow-up during outpatient visit

Study Arms (3)

CONTROL

NO INTERVENTION

CONVENTIONAL TREATMENT

EXPERIMENTAL

EXPERIMENTAL

VR GAMES

Device: VIRTUAL REALITY

PLACEBO

PLACEBO COMPARATOR

VR VIDEOS 360º

Device: VIRTUAL REALITY

Interventions

VIRTUAL REALITY DEVICE

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).

EXPERIMENTAL; PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Castilla-La Mancha: collaborator
• Hospital Universitario del Sureste: collaborator
• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Jara María Esteban Sopeña, PhD Student

CONTACT

913 24 80 64; jaramaria.esteban@ufv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 27, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share