Clinical trial · Interventional
Virtual Reality for Port-a-Cath Access
Virtual Reality for Procedural Distress in Children Undergoing Port-a-Cath Access: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Children with cancer almost universally receive port-a-catheters (ports) to deliver medication, fluids, blood products, and conduct blood tests. Port access requires a needle inserted through the skin to the subcutaneous tissue. Despite the application of topical anesthetic, port access can be painful and anxiety producing. Virtual reality (VR) interfaces provide a strategy to reduce anxiety and have been employed in other painful procedures in children. This trial will explore the effectiveness of VR in children undergoing port access.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology Pain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No or non-technologic distraction | Other | — | UNRESOLVED |
| Tables distraction | Device | — | UNRESOLVED |
| Virtual reality | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Virtual Reality
- description
- The Oculus 2 headset will be used during port access. The device features a stereoscopic display mounted on a lightweight wireless head mounted display weighing 503 g with built-in 3D audio and an adjustable head strap and adjustable lens distance. The software used will be the Might Pebbles VR Game developed by ManageXR. It is a child-friendly VR game that does not require the use of hand controllers. It also provides an option to increase the cognitive load, making it appropriate for children of all ages. The experimental group will be given up to 10 minutes to familiarize themselves with the device, assisted by the research assistant and will begin using it 5-10 minutes prior to port access. Most participants will receive topical anesthestic in the form of 4% amethocaine (Ametop), eutectic mixture of lidocaine and amethocaine (EMLA), or 4% lidocaine (Maxilene) as per standard practice at our institution. However, some participants may refuse this co-intervention.
- interventionNames
- Device: Virtual reality
- type
- ACTIVE_COMPARATOR
- label
- Tablet
- description
- The child will watch a video on a tablet or iPad that is appropriate for their age during port access. They will begin using it 5-10 minutes prior to port access. The content of the video will be at the discretion of the child life specialist, nurse, or caregiver. Most participants will receive topical anesthestic in the form of 4% amethocaine (Ametop), eutectic mixture of lidocaine and amethocaine (EMLA), or 4% lidocaine (Maxilene) as per standard practice at our institution. However, some participants may refuse this co-intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Children age 5 to 17 years of age who are undergoing port-a-cath access * Pre-intervention Children's Fear Scale score of at least 1 with respect to the impending port-a-cath access Exclusion Criteria: * Subjective report of motion sickness within past 12 months (excluding anticipatory nausea a child may experience en route to their medical appointment) * Subjective history of claustrophobia Requires timely antimicrobial therapy * Visual, auditory, or cognitive impairment or language barrier precluding comprehension of study-related tasks or safe interaction with VR * Medical record documentation of current MRSA infection * Subjective history of concurrent respiratory infection (defined as cough, sore throat, fever, coryza, or sneezing within the past 24 hours) or gastrointestinal infection (defined as any vomiting or diarrhea within past 24 hours) * Previous enrollment in study * Seizure disorder * History of vertigo or neurological disorder that creates moderate to severe dizziness.
References
Publications (0)
Data not yet available