Clinical trial NCT06927804: Utilization of Virtual Reality to Increase Comfort and Reduce the Sensation of Pain During Port Insertion Into the Body
Official title: Utilization of Virtual Reality to Reduce Patient Discomfort During the Implantation of a Subcutaneous Venous Port Prior to the Initiation of Oncological Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology Patients
Keywords: Virtual reality
subcutaneous venous port
anxiety
stress
pain
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This interventional study compares two approaches to subcutaneous venous port implantation in adult oncology patients: standard care versus standard care with the use of immersive virtual reality to reduce pain, stress, and anxiety.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled study evaluates whether virtual reality (VR) can reduce pain, 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.

Pain will be measured using the Visual Analog Scale (VAS), and physiological parameters (blood pressure, heart rate, variability) will be monitored 30 minutes before, during, and 30 minutes after the procedure. Anxiety and stress will be assessed using the STAI-6 questionnaire (pre/post) and salivary cortisol (pre/mid/post). The study aims to validate VR as a non-pharmacological tool to improve patient comfort and reduce procedural distress.

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, thereby helping to prevent vascular complications and improve long-term treatment tolerability.

Although generally well tolerated, the procedure is still invasive and often associated with varying degrees of pain, anxiety, and psychological stress. It is performed under local anesthesia, usually accompanied by symptomatic analgesia and/or mild sedation, and lasts approximately 60 minutes.

The application of virtual reality (VR) during such procedures represents a non-pharmacological method that may contribute to alleviating pain and reducing psychological distress by immersing the patient in a controlled, engaging, and calming virtual environment. VR-based distraction techniques have been shown in prior studies to divert attention from unpleasant stimuli and to reduce both subjective and physiological stress responses.

This randomized study aims to evaluate the effectiveness of virtual reality in reducing pain, anxiety, and stress during venous port implantation in adult oncology patients. Two study arms will be compared:

* control group (standard of care with local anesthesia and optional symptomatic sedation),
* VR group (standard of care with additional virtual reality intervention during the procedure).

Pain Assessment

Pain will be evaluated using the Visual Analog Scale (VAS), administered in a standardized three-point timeline:

* 30 minutes before the procedure,
* during the procedure (at a pre-defined time point),
* 30 minutes after the procedure.

In addition, physiological parameters associated with stress and discomfort will be monitored in all patients at the same three time points:

* blood pressure,
* heart rate,
* heart rate variability. These measurements will likewise be obtained 30 minutes before, during, and 30 minutes after the procedure using standardized protocols.

Anxiety and Stress Evaluation

Psychological stress and anxiety will be assessed through a combination of subjective and objective measures:

The State-Trait Anxiety Inventory - short version (STAI-6) will be administered:

* 30 minutes before the procedure, and
* 30 minutes after the procedure.

Salivary cortisol levels, serving as an objective biomarker of stress response, will be collected:

* 30 minutes before the procedure (baseline),
* midway through the procedure, and
* 30 minutes after the procedure.

All measurements will be conducted using standardized collection protocols and under consistent environmental and procedural conditions to ensure reproducibility and comparability of data.

If a statistically and clinically significant reduction in perceived pain and anxiety is observed in the VR group, the second phase of the study will explore the potential of VR as a dose-sparing strategy for pharmacological analgesia, which may contribute to reduced medication burden and enhanced patient comfort during minor oncological procedures.

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

Primary outcomes:
measure: Changes in the level of pain
timeFrame: 2 hours
measure: Changes in the level of stress and anxiety
timeFrame: 2 hours
Secondary outcomes:
measure: Changes in blood pressure
timeFrame: 2 hours
measure: Changes in heart rate
timeFrame: 2 hours
measure: Changes in heart rate variability
timeFrame: 2 hours
measure: The dose of sedation and analgesia medication
timeFrame: 2 hours
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Lukáš Knybel, Ing., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.