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Virtual Reality for Pain and Anxiety During Medical Procedures
N/A
Waitlist Available
Led By Andy M Chang, MD
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be administered to participants approximately 20 minutes before the start of the vcug.
Awards & highlights
Study Summary
This trial will test if virtual reality can help reduce pain and anxiety for children during a medical procedure.
Who is the study for?
This trial is for English or Spanish speaking children aged 5-21 undergoing a bladder diagnostic scan at CHLA, without cognitive/neurological disorders, not on pain/anxiety meds, and with normal development. Children with seizures, psychiatric disorders, sensory deficits, motion sickness or regular catheterization are excluded.Check my eligibility
What is being tested?
The study tests if VR using Oculus Go can reduce pain and anxiety in kids during bladder scans (VCUG) at CHLA. It's a non-drug approach to help cope with the discomfort of catheterization required during these urological exams.See study design
What are the potential side effects?
Potential side effects from using VR may include motion sickness in some children. However, those prone to motion sickness are not included in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ will be administered to participants approximately 20 minutes before the start of the vcug, and within 15 minutes following the end of the vcug.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be administered to participants approximately 20 minutes before the start of the vcug, and within 15 minutes following the end of the vcug.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain during VCUG - Pain Visual Analog Scale
Secondary outcome measures
Baseline Anxiety before VCUG - Anxiety Sensitivity Index
Change in Anxiety during VCUG - Facial Affective Scale
Change in Anxiety during VCUG - Procedural Anxiety Visual Analog Scale
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VR RandomizationExperimental Treatment1 Intervention
Patients will receive virtual reality in addition to standard of care.
Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention
Patients will receive standard of care during catheterization, which includes caregiver presence in the room and Child Life Specialists in the room, if desired, and does not include virtual reality.
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Who is running the clinical trial?
National Association of Theater OwnersUNKNOWN
Children's Hospital Los AngelesLead Sponsor
232 Previous Clinical Trials
5,076,358 Total Patients Enrolled
Andy M Chang, MDPrincipal InvestigatorChildren's Hospital Los Angeles
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Eligibility Criteria:
This trial includes the following eligibility criteria:- This criterion applies to children who are having a VCUG procedure at CHLA.The child has a mental or neurological condition like anxiety, autism, or intellectual disability.The child has trouble seeing, hearing, or feeling things, which would make it hard for them to do the tasks in the study.The child currently has flu-like symptoms, a headache, or an earache.The child experiences motion sickness or is likely to experience it.The child needs to use a catheter regularly or has a numb urethra.Kids between 5 and 21 years oldThe child is currently taking pain medication or anxiety medication, like midazolam.The child has a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (No VR) Randomization
- Group 2: VR Randomization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I qualify to join this medical study?
"Participants in this clinical trial must be aged 5-21 and possess urogenital anomalies. A total of 410 people are needed to complete the study's requirements."
Answered by AI
Are people of any age being accepted into this medical experiment?
"According to the qualifying parameters of this trial, individuals aged 5-21 are applicable. This trial is limited to 7 participants below 18 years and 29 above 65 years old."
Answered by AI
Is there still capacity for participants in this clinical research project?
"Clinicaltrials.gov reveals that this study, which was first posted on February 15th 2020 and most recently updated June 13th 2023, is not presently accepting patients. However, there are other 36 trials seeking recruits at the moment."
Answered by AI
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