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NCT Number: NCT06927804

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location status: Recruiting

Location contact

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Lukáš Knybel, Ing., PhD

PRINCIPAL_INVESTIGATOR

Martin Palička, MD

SUB_INVESTIGATOR

Tomáš Blažek, MD, PhD

SUB_INVESTIGATOR

Štefan Reguli, MD, PhD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality intervention

Procedure

A virtual reality device will be used in one study arm during the implantation of the subcutaneous port.

Standard Care (in control arm)

Procedure

Patients in this study arm will receive standard care, without the use of VR.

Primary outcomes

  1. Changes in the level of pain

    Time frame: 2 hours

    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. Changes in the level of stress and anxiety

    Time frame: 2 hours

    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.

  3. Changes in the level of procedural discomfort

    Time frame: 2 hours

    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".

Secondary outcomes

  1. Changes in blood pressure

    Time frame: 2 hours

    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. Changes in heart rate

    Time frame: 2 hours

    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.

  3. Changes in heart rate variability

    Time frame: 2 hours

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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