Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2022-04-26
2024-12-01
Brief Summary
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Detailed Description
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Port-a-caths are a medical device that is implanted below the skin, which acts as a type of venous access. They are used in pediatric oncology patients for various reasons including administration of chemotherapeutics, blood products and supportive care medication, venous sampling and diagnostic testing. At our centre, 90% of patients have a port, while the 10% remaining either have a Hickman catheter or PICC line. Acute lymphoblastic leukemia (ALL), has a treatment duration of two and half years which is facilitated by the insertion of a port-a-cath. To access a port, the area is cleaned in a sterile fashion and a needle is inserted through the skin, into the port. Ports must be flushed with heparin for line maintenance every 4-6 weeks. Currently, topical analgesics such as EMLA (lidocaine/prilocaine), and distraction methods such as interactive toys and watching videos, and anticipatory guidance are employed to help decrease the amount of pain and anxiety children encounter while their port is accessed5,6. Although topical analgesia and child life interventions may decrease the amount of procedural pain and distress, they do not fully eliminate it. Virtual Reality (VR) has been commercially available for almost 25 years, but the initially high cost prohibited widespread clinical adoption. It is being explored as a potential form of analgesia, and has been found to be effective at decreasing pain in numerous settings including in pediatric burn patients undergoing dressing changes, outpatient venipuncture, and port-cath access. The mechanism by which VR works to reduce pain is still unclear, but it has been suggested that it is through distraction. Studies using functional MRI have also shown that VR reduces pain-associated brain activity. For some children, the use of topical agents prolongs the period of distress in anticipation of port access, something, which the use of VR may diminish/eliminate.
Given that VR technology is still quite new, there have been limited studies in the use of VR in port-a-cath access. Sample sizes of previous studies investigating the use of VR in port-a-cath access have been small, ranging between 20 to 59 patients. Additional limitations include the use of non-objective, self-report and proxy measures of distress, use of a non-active comparator (no intervention), and the lack of young children (\< 7 years). However, port-a-cath access is common in young children and is often more distressing. Further, for some children the use of topical agents for access creates/prolongs period of distress to do anticipation of port-a-cath access. Behavioral measures of distress are more accurate than self-report and proxy measures. Standards of care to reduce procedural distress usually involves some type of distraction too. To optimize the external generalizability of our findings, the investigators have designed a trial to overcome these limitations, including a larger sample size, an objective measure of behavioral distress, inclusion of younger children, and an active comparator.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Virtual Reality
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.
Virtual reality
VR headset will be used 5-10 minutes prior to and during port access
Tablet
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.
Tables distraction
Tablet distraction will be used 5-10 minutes prior to and during port access
No or non-technologic distraction
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.
No or non-technologic distraction
This approach will be used 5-10 minutes prior to and during port access
Interventions
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Virtual reality
VR headset will be used 5-10 minutes prior to and during port access
Tables distraction
Tablet distraction will be used 5-10 minutes prior to and during port access
No or non-technologic distraction
This approach will be used 5-10 minutes prior to and during port access
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pre-intervention Children's Fear Scale score of at least 1 with respect to the impending port-a-cath access
Exclusion Criteria
* 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.
5 Years
17 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Locations
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London Health Sciences Centre
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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119117
Identifier Type: -
Identifier Source: org_study_id