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Virtual Reality for Cancer Pain Management
N/A
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Children age 5 to 17 years of age who are undergoing port-a-cath access
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during intervention
Awards & highlights
Study Summary
This trial will explore the effectiveness of VR in children undergoing port access to see if it reduces anxiety and pain.
Who is the study for?
This trial is for children aged 5 to 17 who need a port-a-cath for cancer treatment and are at least somewhat scared of the procedure. Kids can't join if they don't meet these age or fear level requirements.Check my eligibility
What is being tested?
The study tests how well virtual reality (VR) helps kids feel less pain and anxiety during port-a-cath access, compared to using tablets or no tech distractions.See study design
What are the potential side effects?
While VR is generally safe, it may cause dizziness, nausea, or eye strain in some children. The other methods have minimal side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child, aged 5-17, is getting a port-a-cath.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Behavioral distress
Secondary outcome measures
Fear
Frequency of adverse events
Immersiveness
+1 moreOther outcome measures
Duration of port-a-cath access procedure
Length of stay
Need for physical restraint during port access
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Virtual RealityExperimental Treatment1 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.
Group II: TabletActive Control1 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.
Group III: No or non-technologic distractionActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual reality
2020
N/A
~1890
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,642 Total Patients Enrolled
1 Trials studying Cancer Pain
600 Patients Enrolled for Cancer Pain
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is my profile suitable for enrollment in this research trial?
"This clinical trial caters to patients aged 5-17 that are experiencing pain. Qualifying candidates will have the opportunity to join a cohort of 90 individuals in total."
Answered by AI
What is the cap on participants for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently looking for volunteers who can take part in the study. The protocol was initially published on April 26th 2022 and subsequently modified on May 10th 2022; 90 patients need to be recruited from a single site."
Answered by AI
Is the eligibility criteria of this trial limited to adults under 35?
"This clinical trial is searching for participants aged 5 or above, but not exceeding 17 years."
Answered by AI
Are new volunteers still accepted for this medical experiment?
"Affirmative. Records found on clinicaltrials.gov demonstrate that this medical research project, which was initiated in April 26th 2022, is recruiting subjects. Ninety participants must be recruited from 1 trial centre."
Answered by AI
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