Utilization of Virtual Reality to Increase Comfort and Reduce Procedural Distress During Port Insertion Into the Body
NCT ID: NCT06927804
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-01
2026-12-31
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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VR Group
In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure.
Virtual reality intervention
A virtual reality device will be used in one study arm during the implantation of the subcutaneous port.
Non-VR Group
In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure.
Standard Care (in control arm)
Patients in this study arm will receive standard care, without the use of VR.
Interventions
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Virtual reality intervention
A virtual reality device will be used in one study arm during the implantation of the subcutaneous port.
Standard Care (in control arm)
Patients in this study arm will receive standard care, without the use of VR.
Eligibility Criteria
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Inclusion Criteria
* Signed Informed Consent Form
* Patients Indicated for oncology treatment administration using subcutaneous port
Exclusion Criteria
* Patients \< 18 years of age
* Patients unsuitable for subcutaneous port implantation
18 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Lukáš Knybel, Ing., PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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Jiří Hynčica
Role: primary
References
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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.
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.
Other Identifiers
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LERCO Research Project
Identifier Type: OTHER
Identifier Source: secondary_id
FNO-ONK-VIREPO
Identifier Type: -
Identifier Source: org_study_id