Virtual Reality for Port-a-Cath Access

NCT04931745 | Completed

• 1 other identifier: 119117
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oncology Pain

Outcome Measures

Primary Outcomes (1)

• Behavioral distress

  The Observational Scale of Behavioral Distress - Revised (OSBD-R) will be used. The OSBD-R is an 8-factor, weighted observational scale with total scores ranging between 0 to 23.5 (0 = no distress, 23.5 = maximal distress) , validated in children 1 to 20 years of age for measuring distress associated with medical procedures. This will be measured at the first attempt at port access.

  During intervention

Secondary Outcomes (4)

• Pain Intensity

  During intervention

• Fear

  During intervention

• Immersiveness

  During intervention

• Frequency of adverse events

  During intervention

Other Outcomes (6)

• Parental distress

  During intervention

• Need for physical restraint during port access

  During intervention

• Number of port-a-cath access attempts

  During intervention

Study Arms (3)

Virtual Reality

EXPERIMENTAL

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.

Device: Virtual reality

Tablet

ACTIVE COMPARATOR

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.

Device: Tables distraction

No or non-technologic distraction

ACTIVE COMPARATOR

This is no distraction or non-technologic distraction measures such as bubbles, etc., facilitated by the child life specialist, nurse, or caregiver during port access. The measure will be documented for the purposes of analysis. They 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.

Other: No or non-technologic distraction

Interventions

Virtual reality DEVICE

VR headset will be used 5-10 minutes prior to and during port access

Also known as: Oculus 2

Virtual Reality

Tables distraction DEVICE

Tablet distraction will be used 5-10 minutes prior to and during port access

Also known as: iPad

Tablet

No or non-technologic distraction OTHER

This approach will be used 5-10 minutes prior to and during port access

No or non-technologic distraction

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W3, Canada

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: June 18, 2021
• Study Start: April 26, 2022
• Primary Completion: September 1, 2025
• Study Completion: November 15, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)