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.
Patients ≥ 18 years old
Patients undergoing first-time CVC or Midline catheter insertion
Patients with cognitive impairment
Communication barriers
Acute pain (VAS > 3)
Epilepsy
Parallel
Immersive Virtual Reality
Other interventionThe 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)
DevicePlacement 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
DrugSubcutaneous local anesthetic administered at the puncture site prior to vein needle insertion to minimize procedural pain
Chlorhexidine Gluconate 2%
DrugTopical antiseptic agent applied to the skin at the insertion site for preoperative skin preparation and antisepsis
Self-Reported Procedural Anxiety Level
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)
Self-Reported Procedural Pain Intensity
Measured using the Visual Analog Scale (VAS) for pain, which serves as a subjective indicator of pain intensity. The scale ranges from 0 to 10, where 0 represents 'no pain' and 10 represents the 'worst possible pain'. Patients select the point along the scale that best reflects their experienced pain level
Salivary HPA-Axis Metabolites
Objective physiological indicators of pain, anxiety, and stress measured through biochemical analysis of saliva. Two salivary samples will be collected using Salivette® devices. Following extraction, samples will be centrifuged, labeled, and stored at -80 °C. Laboratory analysis will be performed at the Hospital del Mar Research Institute to determine the levels of hypothalamic-pituitary-adrenal (HPA) axis metabolites, including cortisol, cortisone, and their main metabolites (20α-dihydrocortisol, 20β-dihydrocortisol, 20α-dihydrocortisone, 20β-dihydrocortisone). Results will be reported as numerical concentration values
Vein Diameter Variation
Measurement of the target vein diameter (expressed in millimeters) using an ultrasound scanner, serving as an objective physiological indicator of the vascular response to anxiety (vasoconstriction). The evaluation compares the baseline state at rest with the diameter during the vascular access procedure.
Patient Satisfaction with the Care Received
Evaluated using an ad hoc satisfaction survey regarding the catheter insertion procedure. The items are recorded on a 5-point Likert scale with five response options: 5 (Excellent), 4 (Very good), 3 (Good), 2 (Fair), and 1 (Poor). The total numerical score will be analyzed to assess the patient's perception of the care quality.
Click on the lead sponsor to view all of their trials.
diana garcia
Lead sponsor
Parc de Salut Mar
Sponsor institution
Hospital del Mar Research Institute (IMIM)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
