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NCT07696156
Immersive VR to Reduce Stress, Anxiety, and Pain During PICC/Midline Placement
Conditions: Vasoconstriction, Biomarkers, Central Venous Catheters, Midline Catheter, Pain, Anxiety, Catheterization, Peripheral Venous Catheterization, Stress (Psychology)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 202
Sponsor: diana garcia
Location: Hospital del Mar Barcelona Barcelona
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 Criteria
Inclusion Criteria:
* Patients ≥ 18 years old
* Patients undergoing first-time CVC or Midline catheter insertion
Exclusion Criteria:
* Patients with cognitive impairment
* Communication barriers
* Acute pain (VAS \> 3)
* Epilepsy
* Brain neoplasm or brain metastases
* Previous or simultaneous invasive procedures
Source: ClinicalTrials.gov (NCT07696156). StuddyBuddy aggregates publicly available trial information.