Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Castilla-La Mancha | OTHER |
| Hospital Universitario del Sureste | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | No Intervention | CONVENTIONAL TREATMENT | |
| EXPERIMENTAL | Experimental | VR GAMES |
|
| PLACEBO | Placebo Comparator | VR VIDEOS 360º |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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). |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jara MarÃa Esteban Sopeña, PhD Student | Contact | 913 24 80 64 | 1665 | jaramaria.esteban@ufv.es |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |