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Virtual Reality for Port-a-Cath Access

Primary Purpose

Oncology Pain

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual reality
Tables distraction
No or non-technologic distraction
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oncology Pain

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Virtual Reality

Tablet

No or non-technologic distraction

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Intensity
Pain intensity will be measured using the Faces Pain Scale - Revised (FPS-R) immediately following port-a-cath access and reflective of the pain experienced during port access. The Faces Pain Scale is a self-reported measure that uses 6 faces to assess the intensity of children's pain26. It has been validated in children as young as 4 years of age and has a strong positive correlation with the visual analogue scale (r = 0.93 in children 5-12 years of age; r = 0.92 in children 4-12 years of age) and the colour analogue scale (r = 0.84 in children 4-12 years old). It conforms closely to a linear rating scale.
Fear
Measured using the Children Fear Scale (CFS) immediately following port-a-cath access and reflective of fear felt during port access. The Children's Fear Scale is a visual scale validated to measure fear in children as young as 5 years old undergoing a painful medical procedure. It was originally validated in children undergoing venipuncture and showed interrater reliability of 0.51, test-retest reliability of 0.76, convergent validity with another self-report measure of fear of 0.73, and moderate discriminant validity of 0.30 with child coping behaviour and 0.41 with child distress behaviour.
Immersiveness
Measured using the Child Presence Measure (CPM) immediately after port access and reflective of their experience with the VR intervention. This outcome will only be obtained from the participants in the VR group. It has been shown that immersive virtual environments decreases the subjective experience of pain. The Child Presence Measure is a 12-question survey that measures immersiveness of the VR experience.
Frequency of adverse events
These will include but are not limited to: Nausea using the Pediatric Nausea Assessment Tool (PeNAT). The PeNAT is an assessment tool for nausea validated for children undergoing chemotherapy, which uses a standardized script for administration and employs a pictorial scale. Vomiting Dizziness Adverse events will be recorded as those that occur from the initial application of the intervention to 15 minutes post intervention

Full Information

First Posted
May 14, 2021
Last Updated
May 10, 2022
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04931745
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncology Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Experimental
Arm 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.
Arm Title
Tablet
Arm Type
Active Comparator
Arm 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.
Arm Title
No or non-technologic distraction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality
Other Intervention Name(s)
Oculus 2
Intervention Description
VR headset will be used 5-10 minutes prior to and during port access
Intervention Type
Device
Intervention Name(s)
Tables distraction
Other Intervention Name(s)
iPad
Intervention Description
Tablet distraction will be used 5-10 minutes prior to and during port access
Intervention Type
Other
Intervention Name(s)
No or non-technologic distraction
Intervention Description
This approach will be used 5-10 minutes prior to and during port access
Primary Outcome Measure Information:
Title
Behavioral distress
Description
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.
Time Frame
During intervention
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
Pain intensity will be measured using the Faces Pain Scale - Revised (FPS-R) immediately following port-a-cath access and reflective of the pain experienced during port access. The Faces Pain Scale is a self-reported measure that uses 6 faces to assess the intensity of children's pain26. It has been validated in children as young as 4 years of age and has a strong positive correlation with the visual analogue scale (r = 0.93 in children 5-12 years of age; r = 0.92 in children 4-12 years of age) and the colour analogue scale (r = 0.84 in children 4-12 years old). It conforms closely to a linear rating scale.
Time Frame
During intervention
Title
Fear
Description
Measured using the Children Fear Scale (CFS) immediately following port-a-cath access and reflective of fear felt during port access. The Children's Fear Scale is a visual scale validated to measure fear in children as young as 5 years old undergoing a painful medical procedure. It was originally validated in children undergoing venipuncture and showed interrater reliability of 0.51, test-retest reliability of 0.76, convergent validity with another self-report measure of fear of 0.73, and moderate discriminant validity of 0.30 with child coping behaviour and 0.41 with child distress behaviour.
Time Frame
During intervention
Title
Immersiveness
Description
Measured using the Child Presence Measure (CPM) immediately after port access and reflective of their experience with the VR intervention. This outcome will only be obtained from the participants in the VR group. It has been shown that immersive virtual environments decreases the subjective experience of pain. The Child Presence Measure is a 12-question survey that measures immersiveness of the VR experience.
Time Frame
During intervention
Title
Frequency of adverse events
Description
These will include but are not limited to: Nausea using the Pediatric Nausea Assessment Tool (PeNAT). The PeNAT is an assessment tool for nausea validated for children undergoing chemotherapy, which uses a standardized script for administration and employs a pictorial scale. Vomiting Dizziness Adverse events will be recorded as those that occur from the initial application of the intervention to 15 minutes post intervention
Time Frame
During intervention
Other Pre-specified Outcome Measures:
Title
Parental distress
Description
Measured using the Parental Distress Questionnaire (PDQ) immediately following port access and reflective of distress felt related to port-a-cath access. The Parental Distress Questionnaire is a self-reported survey where parents are given 4 emotional adjectives reflecting emotional distress, which are rated on an 11-point numeric scale ranging from 0 = "not at all" to 11 = "extremely" to assess the parent's current distress.
Time Frame
During intervention
Title
Need for physical restraint during port access
Description
Yes or no
Time Frame
During intervention
Title
Number of port-a-cath access attempts
Time Frame
During intervention
Title
Length of stay
Description
Measured from initial nursing assessment to discharge
Time Frame
During intervention
Title
Duration of port-a-cath access procedure
Description
Measured from removal of topical anesthetic (if any) to attempted flush of port.
Time Frame
During intervention
Title
Procedure nurse satisfaction with intervention
Description
Measured from the procedure nurse using the VR Distraction Satisfaction Questionnaire. This Questionnaire was developed by Stinson et al. to measure ease of needle insertion, acceptability of VR intervention use, helpfulness of VR intervention, and impact of VR intervention on clinical work flow (nurses' report). It uses a 5-point Likert scale from "unacceptable" to "very acceptable" for nurses.
Time Frame
During intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamary Coriolano, PhD
Phone
5196856174
Email
kamary.coriolanodasilva@lhsc.on.ca
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naveen Poonai, MD
Phone
6858500
Ext
52011
Email
naveen.poonai@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality for Port-a-Cath Access

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