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Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients
N/A
Recruiting
Led By Neethu Chandran
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
You are currently going to the CCBD clinic at UT Southwestern for cancer treatments
You are under the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a VR device to help reduce anxiety in children aged 5-12 undergoing cancer treatment procedures. The VR goggles show interactive videos to distract the children, making them less anxious. The study aims to see if this method can lower anxiety levels by at least five percent.
Who is the study for?
This trial is for kids aged 5-12 with cancer, treated at the CCBD clinic, who need a port (a long-term IV) accessed multiple times over six months. They must understand and agree to participate. It's not suitable for those outside this group.
What is being tested?
The study tests if Virtual Reality (VR) can lower anxiety in kids before they get medical procedures like port access. Kids will be randomly chosen to use VR or standard distraction methods first, and their anxiety levels will be compared using a special scale.
What are the potential side effects?
Using VR has minimal risks; it might cause discomfort from wearing it or motion sickness but is designed to avoid these issues. Disposable covers are used for hygiene between patients.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are currently receiving cancer treatment at the CCBD clinic at UT Southwestern.
Select...
I am younger than 18 years old.
Select...
I use a port for chemotherapy and blood tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety with the use of VR
Anxiety
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VR (Virtual Reality)Experimental Treatment1 Intervention
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Group II: Non-VR (Virtual reality)Active Control1 Intervention
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for anxiety include pharmacological options like benzodiazepines and SSRIs, and non-pharmacological approaches such as Cognitive Behavioral Therapy (CBT) and distraction techniques like Virtual Reality (VR). Benzodiazepines enhance GABA neurotransmission, providing sedative and anxiolytic effects, while SSRIs increase serotonin levels to improve mood.
CBT focuses on altering negative thought patterns and behaviors. VR and other distraction methods work by diverting attention from anxiety-inducing stimuli.
Understanding these mechanisms helps in creating personalized treatment plans, leading to more effective anxiety management.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,088 Previous Clinical Trials
1,059,570 Total Patients Enrolled
Neethu ChandranPrincipal InvestigatorUT Southwestern
Sarah Rebstock, MDPrincipal InvestigatorUT Southwestern
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Non-VR (Virtual reality)
- Group 2: VR (Virtual Reality)