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

Official 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

Overview

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.

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

Interventions

• Procedure Virtual reality intervention
  A virtual reality device will be used in one study arm during the implantation of the subcutaneous port.
• Procedure Standard Care (in control arm)
  Patients in this study arm will receive standard care, without the use of VR.

Primary outcome measures

• Changes in the level of pain [Time frame: 2 hours]
• Changes in the level of stress and anxiety [Time frame: 2 hours]
• Changes in the level of procedural discomfort [Time frame: 2 hours]

Secondary outcome measures (3)

• Changes in blood pressure [Time frame: 2 hours]
• Changes in heart rate [Time frame: 2 hours]
• Changes in heart rate variability [Time frame: 2 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Czechia · 1 center

• University Hospital Ostrava — Ostrava

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. PMID 37403339
• 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. PMID 35367144

Identifiers

NCT: NCT06927804 · FNO-ONK-VIREPO · LERCO Research Project

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗