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

University Hospital Ostrava

Status: Enrolling

Conditions: Oncology Patients

Treatments: Procedure: Standard Care (in control arm); Procedure: Virtual reality intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06927804

FNO-ONK-VIREPO

LERCO Research Project (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

VR Group

Experimental group

Description:

In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure.

Treatment:

Procedure: Virtual reality intervention

Non-VR Group

Active Comparator group

Description:

In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure.

Treatment:

Procedure: Standard Care (in control arm)