Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 7:10 PM
Study NCT ID:
NCT06927804
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization of Virtual Reality to Increase Comfort and Reduce Procedural Distress During Port Insertion Into the Body
Sponsor:
University Hospital Ostrava
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LERCO Research Project | OTHER | University Hospital Ostrava | View |