Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Pain intensity (VAS)
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age, both sexes
- •Scheduled unilateral knee arthroplasty
- •Adequate cognitive and functional capacity to use virtual reality
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Pain intensity (VAS)
时间窗: 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.
次要结局
- Physical Activity Level (IPAQ)(Baseline and 1-month follow-up during outpatient visit)
- 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)
- Anxiety and depression (Goldberg Anxiety and Depression Scale)(Baseline and 1-month follow-up during outpatient visit)