NCT04931745|Completed
Virtual Reality for Port-a-Cath Access
Virtual Reality for Procedural Distress in Children Undergoing Port-a-Cath Access: A Randomized Controlled Trial
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Virtual Reality for Procedural Distress in Children Undergoing Port-a-Cath Access: A Randomized Controlled Trial
Sponsor study identifier
interventional
84
1 country
1
Study Start
April 26, 2022
Actual (reported)Primary Completion
September 1, 2025
Actual (reported)Study Completion
November 15, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2021
Actual (reported)June 18, 2021
Actual (reported)April 26, 2022
Actual (reported)September 1, 2025
Actual (reported)November 15, 2025
Actual (reported)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
Pain Intensity
During intervention
Fear
During intervention
Immersiveness
During intervention
Frequency of adverse events
During intervention
Parental distress
During intervention
Need for physical restraint during port access
During intervention
Number of port-a-cath access attempts
During intervention
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.
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.
VR headset will be used 5-10 minutes prior to and during port access
Tablet distraction will be used 5-10 minutes prior to and during port access
London Health Sciences Centre
London, Ontario, N6A5W3, Canada
84 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2021
First Posted
June 18, 2021
Study Start
April 26, 2022
Actual (reported)Treatment of Cancer Pain Using an Implantable Intrathecal Pump
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.
This approach will be used 5-10 minutes prior to and during port access
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 1, 2025
Actual (reported)Study Completion
November 15, 2025
Actual (reported)Last Updated
March 12, 2026
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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