Clinical trial NCT04931745: Virtual Reality for Port-a-Cath Access
Official title: Virtual Reality for Procedural Distress in Children Undergoing Port-a-Cath Access: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oncology Pain
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Pain management in pediatric oncology patients is a core component of the care provided. Procedures and treatment administration are the greatest sources of pain for these children, often greater than the pain from the disease itself. Poor initial management for procedures can lead to anxiety and fear, along with a heightened pain response for future procedures. Sensitization, which is an increased reaction to pain, may not only occur at a physiological level, but can also psychologically affect these children, resulting in the development of a fear-avoidance response. This can impede the conduct of diagnostic testing and delivery of therapy. It can also result in an overall fear and avoidance of healthcare settings.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Behavioral distress
timeFrame: During intervention
Secondary outcomes:
measure: Pain Intensity
timeFrame: During intervention
measure: Fear
timeFrame: During intervention
measure: Immersiveness
timeFrame: During intervention
measure: Frequency of adverse events
timeFrame: During intervention
Other outcomes:
measure: Parental distress
timeFrame: During intervention
measure: Need for physical restraint during port access
timeFrame: During intervention
measure: Number of port-a-cath access attempts
timeFrame: During intervention
measure: Length of stay
timeFrame: During intervention
measure: Duration of port-a-cath access procedure
timeFrame: During intervention
measure: Procedure nurse satisfaction with intervention
timeFrame: During intervention
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References: