Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients

NCT07384741 | Active Not Recruiting DMC

• 2 other identifiers: 2025-18Ministero della Salute
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual reality (VR) has increasingly been explored in medical settings as a non-pharmacological intervention for the management of pain and anxiety associated with invasive procedures. By providing immersive and interactive environments, VR is thought to modulate both sensory and emotional components of pain through mechanisms involving focused attention, cognitive engagement, and altered perception, which share similarities with hypnosis-based approaches. Evidence from previous studies, initially conducted mainly in paediatric populations and more recently extended to adults, suggests that VR may effectively reduce procedural anxiety and pain without increasing procedural duration or clinical workload. Oncology patients undergoing the placement of vascular access devices, such as peripherally inserted central catheters (PICC) and PICC-PORTs, frequently experience procedural distress, including anxiety and discomfort, related to the invasive nature of the intervention. Procedural anxiety may negatively influence patient experience, cooperation, and overall tolerance of the procedure, potentially increasing the need for pharmacological anxiolytic or analgesic support. Identifying effective, safe, and easily applicable non-pharmacological strategies to reduce distress during these procedures represents a relevant clinical goal in oncology care. The present study aims to evaluate the effectiveness of virtual reality delivered via a head-mounted display in reducing patient-reported anxiety and pain in adult oncology patients undergoing PICC or PICC-PORT insertion. This study is designed as a prospective, interventional, randomised controlled trial with a 1:1 allocation ratio using an independent, certified web-based randomisation service. Approximately 120 patients will be enrolled at a single centre, the Istituto Oncologico Veneto (IRCCS), and randomly assigned to one of two study arms. Participants allocated to the intervention arm will receive VR in addition to the standard of care (VR + SOC) throughout the vascular access placement procedure, while participants in the control arm will undergo the standard procedure alone (SOC). The VR intervention will be delivered using HypnoVR, a software-based medical device classified as Class I, non-sterile, and compliant with Regulation (EU) 2017/745 on Medical Devices. The intervention will be administered via a head-mounted display with audiovisual content designed to promote relaxation, focused attention, and emotional regulation during the procedure. The primary outcome of this study is a composite patient-reported procedural experience endpoint, assessed immediately after the procedure. The primary analytical component of this composite endpoint is procedural anxiety, measured using a 10-point Visual Analogue Scale for Anxiety (VAS-A). The main statistical analysis will compare changes in VAS-A scores between the intervention group and the control group. The additional dimensions of the composite endpoint, patient-reported comfort, satisfaction and procedural tolerability, are collected concurrently and are not aggregated into a single score. These dimensions are analysed separately and interpreted jointly with procedural anxiety in order to provide an overall assessment of the patient's procedural experience. Secondary outcomes include: 1) procedural pain, assessed using a 10-point Visual Analogue Scale (VAS); 2) physiological parameters, including heart rate and arterial blood pressure; 3) procedural characteristics, such as procedure duration and number of device insertion attempts; 4) qualitative assessment of patients' perceptions and lived experiences of the procedure, analysed using Van Kaam's phenomenological method18. Data collection will include both quantitative and qualitative measures within a mixed-methods framework. Quantitative data will be analysed using descriptive and inferential statistical methods to assess differences between study groups, while qualitative data derived from semi-structured interviews will be analysed using the Van Kaam phenomenological method to explore patients' lived experiences. The aim of this study is to evaluate the effect of an immersive virtual reality intervention on the overall procedural experience of adult oncology patients undergoing PICC and PICC-PORT placement, with patient experience conceived as a primary dimension of quality of care.

Conditions

Neoplams; Pain; Anxiety; Satisfaction; Peripherally Inserted Central Catheters; Catheterization, Central Venous

Keywords

virtual reality; cancer patient; PICC; PICC-PORT; anxiety; pain; satisfaction

Outcome Measures

Primary Outcomes (6)

• Composite patient-reported procedural experience endpoint

  Composite endpoint integrating multiple dimensions of procedural experience, including change in procedural anxiety (principal quantitative driver, measured using the 10-point VAS-A), patient-reported comfort, satisfaction, and procedural tolerability. Assessed immediately post-procedure (T1). The component dimensions are analysed as individual, non-aggregated measures and interpreted jointly. No numerical aggregation of component scores is applied

  Baseline (pre-procedure, day1) and immediately after PICC/PICC-PORT placement (end of procedure, day1).

• Procedural anxiety (principal quantitative driver)

  10-point Visual Analogue Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (worst possible anxiety). Assessed pre-procedure (T0) and post-procedure (T1); change score is the primary focus of analysis.

  Baseline (pre-procedure, day1) and immediately after the procedure (end of procedure, day1).

• Change in pain (VAS, 0-10) from pre-procedure to post-procedure

  The change in pain score (VAS) is calculated as the difference between the post-procedure and pre-procedure values. Positive change scores indicate an increase, and negative change scores indicate a decrease

  Baseline (pre-procedure, day1) and immediately after the procedure (end of procedure, day1).

• Patient comfort (1-4 Likert)

  Single-item rating of comfort during procedure (1=not at all to 4=very)

  Immediately after the procedure (end of procedure, day1).

• Patient-reported satisfaction

  10-point Visual Analogue Scale ranging from 0 (not at all satisfied) to 10 (completely satisfied). Assessed post-procedure (T1).

  Immediately after the procedure (end of procedure, day1).

• Procedural tolerability

  5-point Likert scale ranging from 1 (very poor) to 5 (excellent).

  Immediately after the procedure (end of procedure, day1).

Secondary Outcomes (4)

• Change in heart rate (beats per minute) from baseline to end of procedure

  Baseline (pre-procedure, day1) and end of procedure (day1).

• Change in mean arterial pressure (mmHg) from baseline to end of procedure

  Baseline (pre-procedure, day1) and end of procedure (day1).

• Qualitative Interview

  Post-procedure, Assessed once within 15 to 30 minutes after device placement.

• Procedural characteristics

  Measured from the start to the end of the procedure, recorded immediately after procedure completion.

Study Arms (2)

Arm A: Virtual reality + Standard of care (VR+SOC)

EXPERIMENTAL

Patients will receive standard care for PICC or PICC-PORT placement, combined with VR delivered via a head-mounted display throughout the procedure.The VR system used is HypnoVR, developed by Medival s.r.l. and include a VR headset, Lenovo tablet, and Bluetooth headphones. HypnoVR integrates clinical hypnosis with immersive virtual environments, guided breathing, music therapy-based compositions, and cardiac coherence techniques, providing multisensory therapeutic immersion. Continuous communication with patients will be maintained throughout the session, and patients may select preferred visual and musical environments.

Device: Virtual reality VR

Arm B: Standard of Care (SOC)

NO INTERVENTION

Patients will undergo standard care for PICC or PICC-PORT placement without VR.

Interventions

Virtual reality VR DEVICE

Patients will receive standard care for PICC or PICC-PORT placement, combined with VR (Hypno VR) delivered via a head-mounted display throughout the procedure. HypnoVR integrates clinical hypnosis with immersive virtual environments, guided breathing, music therapy-based compositions, and cardiac coherence techniques, providing multisensory therapeutic immersion. Continuous communication with patients will be maintained throughout the session, and patients may select preferred visual and musical environments.

Arm A: Virtual reality + Standard of care (VR+SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of neoplastic disease (solid or haematological malignancy)
• Patients scheduled for peripherally inserted central catheter (PICC) or PICC-PORT placement
• Ability to understand the Italian language
• Ability and willingness to provide written informed consent

You may not qualify if:

• Refusal to participate in the study
• Inability to provide informed consent
• Visual or auditory impairments that may interfere with the use of a virtual reality head-mounted display
• Sensory deficits involving the anatomical area affected by the procedure
• Cognitive, neurological, or psychiatric disorders that may compromise comprehension, cooperation, or reliability of patient-reported outcomes
• Any condition judged by the investigator to make participation unsafe or inappropriate

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto (IOV) c/o Ospedale San Giacomo, Via dei Carpani, 16/Z, 31033 Castelfranco Veneto (TV).

Castelfranco Veneto, Italy, 31033, Italy

Location

Related Publications (4)

• Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.

  PMID: 31882015 RESULT

• Basak T, Duman S, Demirtas A. Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial. J Clin Nurs. 2020 Mar;29(5-6):770-777. doi: 10.1111/jocn.15131. Epub 2019 Dec 16.

  PMID: 31793099 RESULT

• Schaake R, Leopold I, Sandberg A, Zenk B, Shafer L, Yu D, Lu X, Theingi S, Udongwo A, Cohen GS, Maresky HS. Virtual Reality for the Management of Pain and Anxiety for IR Procedures: A Prospective, Randomized, Pilot Study on Digital Sedation. J Vasc Interv Radiol. 2024 Jun;35(6):825-833. doi: 10.1016/j.jvir.2024.03.004. Epub 2024 Mar 12.

  PMID: 38484911 RESULT

• Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.

  PMID: 31306747 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Pain; Personal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinatrice Infermieristica U.O. Anestesia e Rianimazione IOV Sede di Castelfranco Veneto

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 3, 2026
• Study Start: September 5, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)