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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in the level of pain
Study Overview
Brief Summary
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
VR Group
In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure.
Intervention: Virtual reality intervention (Procedure)
Non-VR Group
In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure.
Intervention: Standard Care (in control arm) (Procedure)
Outcomes
Primary Outcomes
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.
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.
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".
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.
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.
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
- Changes in blood pressure(2 hours)
- Changes in heart rate(2 hours)
- Changes in heart rate(2 hours)
- Changes in blood pressure(2 hours)
- Changes in heart rate variability(2 hours)