What side effects are associated with this type of intervention?

Common treatments for allergies include allergen-specific immunotherapy (subcutaneous, sublingual, oral), and intranasal corticosteroids. Known side effects of sublingual immunotherapy (SLIT) include oral mucosal pruritus, irritation, and transient angioedema, which are typically mild and self-limited. Intranasal corticosteroids may cause nasal irritation and dryness. These treatments, while effective, can have mild to moderate local reactions, making non-pharmaceutical interventions like virtual reality, which aim to reduce pain and anxiety through distraction and sensory modulation, an appealing complementary approach.

What prior FDA approvals exist?

The FDA has approved various treatments for allergies, including pharmacological options like intranasal corticosteroids, antihistamines, and sublingual immunotherapy (SLIT) tablets. These treatments aim to reduce symptoms of allergic rhinitis and conjunctivitis. While the context does not provide specific FDA approvals for non-pharmaceutical interventions like Virtual Reality (VR) for allergy treatment, VR is being studied as a non-pharmaceutical intervention to reduce pain and anxiety during painful procedures, which could be beneficial in allergy testing and other related procedures.

What other types of research exist?

Promising novel alternatives for allergy patients include remote electrical neuromodulation, transcranial magnetic stimulation (TMS), and sublingual immunotherapy (SLIT). These treatments have demonstrated efficacy in clinical trials and may offer new options for managing allergy symptoms.

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VR Therapy for Pain and Anxiety During Medical Procedures

N/A

Recruiting

Led By Jeffrey I Gold, PhD

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

Children who are 7-21 years old

Be younger than 65 years old

Must not have

Children with a history of seizure disorder.

Children with known or suspected motion sickness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 minutes to one hour before procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if VR can reduce pain and anxiety in children aged 7-21 during medical procedures by distracting them with a virtual world. The study compares the effectiveness of using VR versus not using VR. Virtual reality (VR) has been shown to decrease pain and anxiety in children undergoing various medical procedures.

Who is the study for?

This trial is for children aged 7-21 who speak English, undergoing painful medical procedures like IV placements or cast removals. They must be developing normally as reported by parents and not taking pain or anxiety medication, have no seizure history, flu-like symptoms, cognitive disorders, sensory deficits, or motion sickness.

What is being tested?

The study tests if VR headsets (Samsung Gear VR, Merge VR, Oculus Go) can reduce pain and anxiety in kids during medical procedures at CHLA. It measures their comfort levels through what they and their caregivers say.

What are the potential side effects?

There are no medicinal side effects since this is a non-pharmaceutical intervention. However, there may be risks of discomfort from wearing the VR headset or experiencing virtual reality itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child has a history of seizures.

Select...

My child gets motion sickness.

Select...

My child has sensory issues that could affect their participation in the study.

Select...

I am not taking any pain or anxiety medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ peri-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~peri-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and peri-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child Presence Questionnaire

Child Satisfaction Survey

Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older

+6 more

Secondary study objectives

CAMPIS-R

Other study objectives

Demographic Survey

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 RandomizationExperimental Treatment3 Interventions

Children in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction.

Group II: Standard of Care (No VR) RandomizationActive Control1 Intervention

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Samsung Gear VR

2017

N/A

~110

Merge VR

2017

N/A

~110

0 / 5Eligibility criteria met

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 allergies include allergen avoidance, pharmacotherapy, and immunotherapy. Allergen avoidance involves minimizing exposure to known allergens, thereby reducing the immune response. Pharmacotherapy, such as antihistamines and corticosteroids, works by blocking the action of histamines and reducing inflammation, respectively. Immunotherapy, including subcutaneous and sublingual methods, gradually desensitizes the immune system to specific allergens. These treatments are crucial for managing symptoms and improving quality of life for allergy patients. Virtual Reality (VR) as a non-pharmaceutical intervention leverages distraction and sensory modulation to reduce pain and anxiety during allergy testing and other procedures, offering a complementary approach to traditional treatments.

How will we treat asthma in the year 2000?[Appropriate protocol of treatment modulation for seasonal allergic rhinitis caused by cypress pollens].Individualized Household Allergen Intervention Lowers Allergen Level But Not Asthma Medication Use: A Randomized Controlled Trial.