About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients > 18 years of age
Signed Informed Consent Form
Patients Indicated for oncology treatment administration using subcutaneous port
Disqualifiers
Not signing of the Informed Consent Form
Patients < 18 years of age
Patients unsuitable for subcutaneous port implantation
Trial design
Parallel
Treatments tested in this trial
Virtual reality intervention
Procedure/SurgeryA virtual reality device will be used in one study arm during the implantation of the subcutaneous port.
Standard Care (in control arm)
Procedure/SurgeryPatients in this study arm will receive standard care, without the use of VR.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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".
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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