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NCT Number: NCT07286084

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?

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Key information

Conditions

Knee Arthroplasty Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Pain intensity (VAS)

    Time frame: 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.

    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.

Secondary outcomes

  1. Sociodemographic variables

    Time frame: Baseline

    Age, weight, sex, and height recorded at enrollment

  2. Analgesic medication use

    Time frame: From immediate postoperative period to 48 hours post-intervention.

    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.

  3. Adverse events

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

    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")

  4. Satisfaction, Acceptability, and Perceived Safety (SEQ)

    Time frame: Immediately post-intervention

    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

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

    Time frame: Baseline and 1-month follow-up during outpatient visit

    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

  6. Anxiety and depression (Goldberg Anxiety and Depression Scale)

    Time frame: Baseline and 1-month follow-up during outpatient visit

    The Goldberg Scale screens symptoms of anxiety and depression to explore changes associated with the intervention.

  7. Physical Activity Level (IPAQ)

    Time frame: Baseline and 1-month follow-up during outpatient visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jara María Esteban Sopeña, PhD Student

CONTACT

[email protected]

913 24 80 64 ext. 1665

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Collaborators

  • Hospital Universitario del Sureste
  • University of Castilla-La Mancha

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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