Utilization of Virtual Reality to Increase Comfort and Reduce Procedural Distress During Port Insertion Into the Body

Utilization of Virtual Reality to Support Patient Comfort and Reduce Stress During the Implantation of a Subcutaneous Venous Port Prior to the Initiation of Oncological Treatment

This randomised controlled study evaluates whether virtual reality (VR) can support patient comfort and help reduce anxiety and stress during subcutaneous venous port implantation in adult oncology patients. Patients will be assigned to standard care or standard care with VR intervention.

Subjective and objective measures of stress and discomfort will be collected, including the Visual Analog Scale (VAS) for self-reported procedural discomfort, physiological parameters (blood pressure, heart rate, variability), the STAI-6 questionnaire, and salivary cortisol.

The study aims to explore the potential of VR as a non-pharmacological, immersive tool to improve procedural experience and reduce psychological distress in patients undergo-ing minor oncological procedures.

Study Overview

• Status: Recruiting
• Conditions: Oncology Patients
• Intervention / Treatment: Procedure: Virtual reality intervention; Procedure: Standard Care (in control arm)

Detailed Description

The implantation of a subcutaneous venous port is a minor surgical procedure that has become a routine component of oncological care. It is indicated in cases where the expected duration of systemic treatment exceeds six months and where there is a significant risk of damage to the peripheral venous system due to chemotherapy.

Although generally well tolerated, the procedure is invasive and often associated with varying degrees of psychological stress, discomfort, and procedural anxiety. It is performed under local anaesthesia, often accompanied by mild sedation, and typically lasts about 60 minutes.

The application of virtual reality (VR) during such procedures represents a non-pharmacological approach that may help mitigate psychological stress and procedural discomfort by immersing the patient in a calming, engaging virtual environment. VR-based distraction techniques have previously been shown to promote relaxation and improve perceived comfort in various clinical settings.

The aim of this randomised study is to assess the impact of immersive VR on patient comfort, anxiety, and stress during venous port implantation in adult oncology patients.

Two study arms will be compared:

• control group (standard care with local anaesthesia and optional symptomatic sedation)
• VR group (standard care with the addition of immersive VR during the procedure)

Discomfort Assessment: Procedural discomfort will be evaluated using the Visual Analog Scale (VAS), administered in a standardised three-point timeline:

• 30 minutes before the procedure
• during the procedure (at a predefined time point)
• 30 minutes after the procedure

Physiological indicators associated with stress and procedural discomfort will also be recorded at these same time points:

• blood pressure
• heart rate
• heart rate variability

Measurements will follow standardized protocols and consistent conditions.

Anxiety and Stress Evaluation: Psychological stress and anxiety will be assessed using both subjective and objective measures:

• STAI-6 questionnaire administered 30 minutes before and after the procedure
• Salivary cortisol collected before the procedure (baseline), midway through, and 30 minutes after

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • Recruiting
      • University Hospital Ostrava
      • Contact: Jiří Hynčica; Phone Number: 2587 0042059737; Email: jiri.hyncica@fno.cz
      • Sub-Investigator: Štefan Reguli, MD, PhD
      • Principal Investigator: Lukáš Knybel, Ing., PhD
      • Sub-Investigator: Martin Palička, MD
      • Sub-Investigator: Tomáš Blažek, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients > 18 years of age
• Signed Informed Consent Form
• Patients Indicated for oncology treatment administration using subcutaneous port

Exclusion Criteria:

• Not signing of the Informed Consent Form
• Patients < 18 years of age
• Patients unsuitable for subcutaneous port implantation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Group; In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure.	Procedure: Virtual reality intervention; A virtual reality device will be used in one study arm during the implantation of the subcutaneous port.
Active Comparator: Non-VR Group; In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure.	Procedure: Standard Care (in control arm); Patients in this study arm will receive standard care, without the use of VR.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the level of pain	Changes in the level of pain in patients undergoing sub-cutaneous venous port implantation will be measured using the Visual Analog Scale (VAS). The assessment will be performed at three standardized time points: 30 minutes before, during, and 30 minutes after the procedure.	2 hours
Changes in the level of stress and anxiety	Changes in the level of stress and anxiety in patients undergoing sub-cutaneous venous port implantation will be measured using the State-Traint Anxiety Inventory (STAI-6) questionnaire. The assessment will be performed at three standardized time points: 30 minutes before, during, and 30 minutes after the procedure.	2 hours
Changes in the level of procedural discomfort	Subjective discomfort will be measured using the Visual Analog Scale (VAS) at three standardised time points. The scale is a straight, 10-centimetre line with descriptive anchors at each end, like "no pain" and "worst pain imaginable".	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in blood pressure	Changes in blood pressure in patients undergoing sub-cutaneous venous port implantation will be observed at three standardized time points: 30 minutes before, during, and 30 minutes after the procedure and measured in mmHg.	2 hours
Changes in heart rate	Changes in heart rate in patients undergoing sub-cutaneous venous port implantation will be observed at three standardized time points: 30 minutes before, during, and 30 minutes after the procedure and measured in beats per minute.	2 hours
Changes in heart rate variability	Changes in heart rate variability in patients undergoing sub-cutaneous venous port implantation will be observed at three standardized time points: 30 minutes before, during, and 30 minutes after the procedure and measured in beat-to-beat intervals.	2 hours

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Investigators: Principal Investigator: Lukáš Knybel, Ing., PhD, University Hospital Ostrava

Publications and helpful links

General Publications

• Gokce E, Arslan S. Effects of virtual reality and acupressure interventions on pain, anxiety, vital signs and comfort in catheter extraction processes for patients undergoing coronary angiography: A randomized controlled trial. Int J Nurs Pract. 2023 Dec;29(6):e13176. doi: 10.1111/ijn.13176. Epub 2023 Jul 4.
• Menekli T, Yaprak B, Dogan R. The Effect of Virtual Reality Distraction Intervention on Pain, Anxiety, and Vital Signs of Oncology Patients Undergoing Port Catheter Implantation: A Randomized Controlled Study. Pain Manag Nurs. 2022 Oct;23(5):585-590. doi: 10.1016/j.pmn.2022.03.004. Epub 2022 Mar 31.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain; anxiety; stress; Virtual reality; subcutaneous venous port
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: FNO-ONK-VIREPO; LERCO Research Project (Other Identifier: University Hospital Ostrava)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No