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

NCT07696156 | Not Yet Recruiting

• 1 other identifier: 2025/12503/I
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Vasoconstriction; Biomarkers; Midline Catheter; Pain; Anxiety; Catheterization; Peripheral Venous Catheterization; Stress (Psychology); Central Venous Catheters

Keywords

anxiety; pain; Virtual Reality; PICC; Invasive Procedures; Metabolomics; HPA Axis

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (Day 1, prior to catheter insertion), Periprocedural (Day 1, pre-puncture), and Day 1 (immediately upon completion of the implantation).

Secondary Outcomes (5)

• 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)

Study Arms (2)

Standard Procedural Care

OTHER

Hospitalized patients undergoing PICC or Midline catheter insertion who receive the standard institutional nursing protocol for vascular access insertion without any virtual reality intervention.

Device: Peripherally Inserted Central Catheter (PICC); Drug: Mepivacaine 2% Injection; Drug: Chlorhexidine Gluconate 2%

Immersive Virtual Reality (IVR)

EXPERIMENTAL

Participants in this group will receive standard care from the infusion and vascular access nurses responsible for catheter implantation. The procedure includes sterile field preparation and the standard institutional nursing protocol throughout the entire PICC or Midline catheter insertion. Participants in this group will undergo the same vascular access insertion and clinical monitoring as the control group, but with the use of virtual reality headsets.

Other: Immersive Virtual Reality; Device: Peripherally Inserted Central Catheter (PICC); Drug: Mepivacaine 2% Injection; Drug: Chlorhexidine Gluconate 2%

Interventions

Immersive Virtual Reality OTHER

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.

Immersive Virtual Reality (IVR)

Peripherally Inserted Central Catheter (PICC) DEVICE

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.

Immersive Virtual Reality (IVR); Standard Procedural Care

Mepivacaine 2% Injection DRUG

Subcutaneous local anesthetic administered at the puncture site prior to vein needle insertion to minimize procedural pain

Immersive Virtual Reality (IVR); Standard Procedural Care

Chlorhexidine Gluconate 2% DRUG

Topical antiseptic agent applied to the skin at the insertion site for preoperative skin preparation and antisepsis

Immersive Virtual Reality (IVR); Standard Procedural Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Man / Woman / Non-binary / Prefer not to answer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old
• Patients undergoing first-time CVC or Midline catheter insertion

You may not qualify if:

• Patients with cognitive impairment
• Communication barriers
• Acute pain (VAS \> 3)
• Epilepsy
• Brain neoplasm or brain metastases
• Previous or simultaneous invasive procedures

Sponsors & Collaborators

• diana garcia: lead
• Hospital del Mar Research Institute (IMIM): collaborator

Study Sites (4)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Fundació Althaia

Manresa, Barcelona, 08240, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Girona, 17007, Spain

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Catheterization, Peripheral; Mepivacaine; Injections

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy

Study Officials

• Purificación Study Director

  Hospital del Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Lead Trial Coordinator, PhD Candidate

CONTACT

+34-626448584; dgarciasardelli@hmar.cat

Elisabeth Lafuente Cabrero, PhD

CONTACT

+34-659-827-686; elafuente@hmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Advanced Practice Nurse and PhD Candidate in Health Sciences

Model Details: This is a multicenter, two-arm, parallel-group randomized controlled trial conducted across three university hospitals in Catalonia (Spain) that feature a dedicated Infusion and Vascular Access Unit (UIAV). Hospitalized patients scheduled for a PICC or Midline catheter insertion will be randomized (1:1) to either the intervention group (receiving immersive virtual reality distraction throughout the entire procedure) or the control group (receiving standard care). The study model incorporates a collaborative framework with a specialized metabolomics core facility (Hospital del Mar Research Institute) for the bioanalytical analysis of the HPA axis metabolism. Additionally, the experimental design includes pre- and post-procedure physiological tracking (vasoconstriction) and is powered to analyze gender and sex-based differences in response to the IVR exposure.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): January 12, 2028
• Study Completion (Estimated): January 12, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)