Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VIRTUAL REALITY.
- Who it may be relevant to
- Registry conditions: Knee Arthroplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
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.
Interventions
- 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
Primary outcome measures
- 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.]
Secondary outcome measures (7)
- Sociodemographic variables [Time frame: Baseline]
- Analgesic medication use [Time frame: From immediate postoperative period to 48 hours post-intervention.]
- Adverse events [Time frame: Throughout the intervention period and up to 48 hours post-intervention.]
- Satisfaction, Acceptability, and Perceived Safety (SEQ) [Time frame: Immediately post-intervention]
- Health-Related Quality of Life (EQ-5D-5L) [Time frame: Baseline and 1-month follow-up during outpatient visit]
- Anxiety and depression (Goldberg Anxiety and Depression Scale) [Time frame: Baseline and 1-month follow-up during outpatient visit]
- Physical Activity Level (IPAQ) [Time frame: Baseline and 1-month follow-up during outpatient visit]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07286084 · PI 94/25