Oncology PatientsNCT06927804
Utilization of Virtual Reality to Increase Comfort and Reduce Procedural Distress During Port Insertion Into the Body
A study testing Virtual reality intervention in people with Oncology Patients, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology Patients
- What is being tested?
- Virtual reality intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Signed Informed Consent Form
- Patients Indicated for oncology treatment administration using subcutaneous port
Who cannot join
- Not signing of the Informed Consent Form
- Patients < 18 years of age
- Patients unsuitable for subcutaneous port implantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Lukáš Knybel, Ing., PhD
About this study
Official title: 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
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.
Read the 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:
- 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
- Oncology Patients
- Being tested
- Virtual reality intervention, Standard Care (in control arm)
- Keywords
- Virtual reality, subcutaneous venous port, anxiety, stress, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality interventionProcedure or 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 or surgery
Patients in this study arm will receive standard care, without the use of VR.
| Study group | Role | What they receive |
|---|---|---|
| VR Group | Experimental | In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure. Receives: Procedure: Virtual reality intervention |
| Non-VR Group | Active comparator | In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure. Receives: Procedure: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
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.
Measured: 2 hours
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".
Measured: 2 hours
Secondary outcomes (3)
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.
Measured: 2 hours
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.
Measured: 2 hours
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oncology PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukáš Knybel, Ing., PhD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927804
- Sponsor's protocol ID
- FNO-ONK-VIREPO
- Other IDs
- LERCO Research Project
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
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.
PubMed 37403339Menekli 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.
PubMed 35367144
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06927804
- Acronym / sponsor ID
- FNO-ONK-VIREPO
- Conditions
- Oncology Patients
- Keywords
- Virtual reality, subcutaneous venous port, anxiety, stress, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Group | Experimental | Procedure: Virtual reality interventionIn patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure. |
| Non-VR Group | Active comparator | Procedure: Standard Care (in control arm)In patients randomized in this study arm, no virtual reality device will be used during the subcutaneous port implantation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Signed Informed Consent Form
- Patients Indicated for oncology treatment administration using subcutaneous port
Key exclusion criteria (3 listed)
- Not signing of the Informed Consent Form
- Patients < 18 years of age
- Patients unsuitable for subcutaneous port implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality interventionA virtual reality device will be used in one study arm during the implantation of the subcutaneous port. | Procedure or surgery | VR Group |
| Standard Care (in control arm)Patients in this study arm will receive standard care, without the use of VR. | Procedure or surgery | Non-VR Group |
Primary outcome
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".
3 secondary outcomes
Changes in blood pressure
Time frame: 2 hours
Changes in heart rate
Time frame: 2 hours
Changes in heart rate variability
Time frame: 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Background: PubMed 37403339Gokce 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.
- Background: PubMed 35367144Menekli 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.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lukáš Knybel, Ing., PhD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality intervention in people with Oncology Patients, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of pain (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06927804, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.