Knee Arthroplasty
Conditions
Keywords
knee arthroplasty, postoperative pain, acute pain, virtual reality
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?
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
DEVICEVIRTUAL 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).
Sponsors
University of Castilla-La Mancha
Hospital Universitario del Sureste
Universidad Francisco de Vitoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic medication use | 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. |
| Adverse events | 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) |
| Satisfaction, Acceptability, and Perceived Safety (SEQ) | 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 |
| Sociodemographic variables | Baseline | Age, weight, sex, and height recorded at enrollment |
| Anxiety and depression (Goldberg Anxiety and Depression Scale) | 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. |
| Physical Activity Level (IPAQ) | 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. |
| Health-Related Quality of Life (EQ-5D-5L) | 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 |
Contacts
Primary ContactJara María Esteban Sopeña, PhD Student
Outcome results
None listed