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

NCT06927804 | Recruiting

• 2 other identifiers: FNO-ONK-VIREPOLERCO Research Project
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oncology Patients

Keywords

Virtual reality; subcutaneous venous port; anxiety; stress; pain

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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".

  2 hours

Secondary Outcomes (3)

• Changes in blood pressure

  2 hours

• Changes in heart rate

  2 hours

• Changes in heart rate variability

  2 hours

Study Arms (2)

VR Group

EXPERIMENTAL

In patients randomized in this study arm, a virtual reality device will be used during the subcutaneous port implantation procedure.

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.

Procedure: Standard Care (in control arm)

Interventions

Virtual reality intervention PROCEDURE

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

VR Group

Standard Care (in control arm) PROCEDURE

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

Non-VR Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Signed Informed Consent Form
• Patients Indicated for oncology treatment administration using subcutaneous port

You may not qualify if:

• Not signing of the Informed Consent Form
• Patients \< 18 years of age
• Patients unsuitable for subcutaneous port implantation

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (2)

• 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.

  PMID: 37403339 BACKGROUND

• 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.

  PMID: 35367144 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lukáš Knybel, Ing., PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)