Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement

Condition(s) studied

Investigational drug(s) / intervention(s)

Immersive Virtual Reality: The intervention consists of an immersive virtual reality (IVR) software designed to provide continuous non-pharmacological distraction during vascular access. Patients can choose from three distinct natural theme environments: 1) Sensory Forest with views of hot air balloons; 2) Sunrises, Sunsets, and Night Sky / Aurora Borealis; and 3) Underwater Experience. The content is delivered via standalone VR headsets. The experience is administered continuously from prior to the sterile field preparation until the end of the PICC or Midline catheter insertion, adjusting its duration to the length of the procedure.

Peripherally Inserted Central Catheter (PICC): Placement of a Peripherally Inserted Central Catheter (PICC) or a Midline catheter made of polyurethane, depending on the patient's clinical indication and venous capital. The procedure is performed by trained vascular access nurses using ultrasound guidance for vein selection and puncture (typically the basilic or brachial vein). The catheter insertion follows the Modified Seldinger Technique under strict sterile conditions. The device may have single, double, or triple lumens, with a caliber ranging from 3Fr to 5Fr. For PICC lines, the correct tip position in the lower third of the superior vena cava is verified using intracavitary ECG or post-procedure chest X-ray.

Mepivacaine 2% Injection: Subcutaneous local anesthetic administered at the puncture site prior to vein needle insertion to minimize procedural pain

Chlorhexidine Gluconate 2%: Topical antiseptic agent applied to the skin at the insertion site for preoperative skin preparation and antisepsis

Study summary

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.

Eligibility

Primary outcome measure(s)

• Self-Reported Procedural Anxiety Level — 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)

Trial sites (4)

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