ESTAR-VR Project: Randomized Controlled Trial on the Impact of Virtual Reality on Reducing Stress, Anxiety, and Pain During Invasive Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
- 试验地点
- 3
- 主要终点
- Self-Reported Procedural Anxiety Level
研究概览
简要总结
Medical and technological advancements allow increasingly complex invasive procedures to be performed on hospitalized patients, improving their survival rates and prognosis. However, these interventions impact physical, emotional, and psychological health. In this scenario, post-hospitalization syndrome (PHS) emerges as a concerning phenomenon characterized by functional, emotional, and social decline after discharge. Invasive procedures such as surgeries or prolonged use of catheters not only compromise physical integrity but also contribute to disorders like anxiety, depression, and post-traumatic stress. In fact, between 20% and 30% of patients admitted to the Intensive Care Unit (ICU) develop symptoms compatible with post-traumatic stress disorder. This underscores the need for a comprehensive approach focused on psychological and social well-being during and after the hospital stay. Despite humanization initiatives, few hospitals successfully implement them due to a lack of objective evaluations and clinical recommendations that justify their necessity.
In this regard, venous catheterization (VC) is the most prevalent invasive procedure. The pain, anxiety, or fear caused by this technique triggers physiological and psychological alterations that can interfere with the successful insertion of the device. This stress response induces vasoconstriction, reducing the caliber of the vein, which increases technical difficulty, elevates the risk of complications, raises healthcare costs, and negatively impacts patient satisfaction.
Natural outdoor environments have been shown to reduce stress, enhancing well-being and health in the general population. In this sense, the use of immersive virtual reality (IVR) to achieve immersion in virtual nature could help not only by diverting attention away from the painful or anxiety-inducing stimulus during invasive procedures but also by providing pleasant stimuli that could have a physiological impact.
The objective of this study is to evaluate the impact of IVR on stress and anxiety during VC using validated clinical scales, measuring the caliber of the vessel to be punctured, and determining salivary biomarkers of stress, well-being, and pain. Confirming this hypothesis will provide the evidence to integrate virtual reality into the National Health System as a standard tool for more humanized and innovative care.
详细描述
BACKGROUND:
In 2010, the Society of Critical Care Medicine defined Post-Intensive Care Syndrome (PICS) to address the short- and long-term physical, cognitive, and psychological symptoms affecting ICU survivors. Clinical studies show these impairments affect up to 58% of medical ICU patients, 64% of emergency surgery patients, and 43% of elective surgery patients, prompting humanization initiatives like the "HUCI" project. Recently, evidence shows this vulnerability is not exclusive to the ICU but affects general hospitalized patients. Post-Hospitalization Syndrome (PHS) is a transient period of health vulnerability following acute illness, marked by a high risk of early readmission driven by stressors like sleep disruption, poor pain control, malnutrition, and invasive procedures. Despite humanization efforts, few hospitals successfully implement them due to a lack of objective clinical evaluations and specific recommendations justifying their necessity.
Both venipuncture and venous catheterization are the most prevalent painful invasive procedures performed on hospitalized patients. Frequently, these techniques provoke continuous fear and/or anxiety, feelings that compound the distress or fear already experienced by patients due to the mere fact of being hospitalized.
VCs are essential for intravenous therapies, blood sampling, and hemodynamic monitoring, yet they carry risks such as infection, thrombosis, nerve injury, hematoma, multiple punctures, pain, and anxiety.
Globally, approximately 2 billion VCs are placed annually. In line with this, according to the latest report from the Nosocomial Infection Prevalence Study in Spain (EPINE), 76.6% of hospitalized patients are carriers of a Peripheral Venous Catheter (PVC), while 12.3% carry a Central Venous Catheter (CVC). In recent years, the use of Peripherally Inserted Central Catheters (PICCs) has been increasing, and they are now among the most common types of CVCs inserted. The same trend is observed with Midline catheters, which are mid-length peripheral venous devices that have re-emerged and are increasingly utilized in patients requiring a PVC.
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
- Single (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
- •Patients ≥ 18 years old
- •Patients undergoing first-time CVC or Midline catheter insertion
排除标准
- •Patients with cognitive impairment
- •Communication barriers
- •Acute pain (VAS > 3)
- •Brain neoplasm or brain metastases
- •Previous or simultaneous invasive procedures
结局指标
主要结局
Self-Reported Procedural Anxiety Level
时间窗: Baseline (Day 1, prior to catheter insertion), Periprocedural (Day 1, pre-puncture), and Day 1 (immediately upon completion of the implantation).
Measured using the Visual Analog Scale for Anxiety (VAS-A), validated in pre-surgical procedures (Facco et al., 2013), which shows a statistically significant correlation with the STAI-State scale (considered the gold standard). The scale consists of a 10 cm horizontal line where patients select the point that indicates their anxiety intensity. Scores range from 0 to 10, defined as follows: 0 indicates no anxiety (left end); \> 0 and ≤ 2 indicates mild anxiety; \> 2 and ≤ 5 indicates moderate anxiety; \> 5 and ≤ 8 indicates severe anxiety; and \> 8 and ≤ 10 indicates the most severe anxiety (right end)
次要结局
- Self-Reported Procedural Pain Intensity(Baseline (Day 1, prior to the procedure) and Day 1 (immediately upon completion of the implantation))
- Salivary HPA-Axis Metabolites(Baseline (Day 1, prior to the procedure) and Day 1 (30 minutes post-implantation); with a total elapsed time between both samples of less than 2 hours)
- Vein Diameter Variation(Baseline (Day 1, at rest prior to the procedure) and Periprocedural (Day 1, at the exact moment of needle puncture))
- Patient Satisfaction with the Care Received(Day 1 (30 minutes post-catheter implantation))
- Clinical Feasibility and Usability of the ESTAR-VR Program(At study completion (an average of 1 year))
研究者
diana garcia
Advanced Practice Nurse and PhD Candidate in Health Sciences
Parc de Salut Mar