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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Virtual reality intervention

    Procedure/Surgery

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

  • Standard Care (in control arm)

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: VR GroupExperimental treatment 1 intervention
Group B: Non-VR GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2 hours
2

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.

Time frame
2 hours
3

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".

Time frame
2 hours

Secondary outcomes

1

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.

Time frame
2 hours
2

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.

Time frame
2 hours
3

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.

Time frame
2 hours

Other outcomes

Sponsors and contacts

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