What side effects are associated with this type of intervention?

Common treatments for anxiety, such as music therapy and pharmacological interventions, have varying side effects. Music therapy generally has no adverse effects and can reduce anxiety levels effectively. Benzodiazepines, like midazolam and diazepam, are often used for their sedative properties but can cause drowsiness, dizziness, and dependency with long-term use. SSRIs and SNRIs, such as sertraline and duloxetine, are preferred for their lower risk of dependency but can cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. These treatments offer different benefits and risks, and their side effects should be considered when choosing the best approach for managing anxiety.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of anxiety, including benzodiazepines (e.g., lorazepam, alprazolam), selective serotonin reuptake inhibitors (SSRIs), and other anxiolytics like buspirone. Non-pharmacologic interventions such as music therapy and virtual reality (VR) distraction are also being studied for their efficacy in reducing preoperative anxiety, though VR distraction itself is not yet FDA-approved specifically for anxiety treatment. These approaches aim to provide non-sedative options to manage anxiety effectively.

What other types of research exist?

Promising, novel alternatives to Virtual Reality (VR) for reducing preoperative anxiety include: 1) Need-based education tailored to the patient's preferences, which has shown to reduce anxiety and increase satisfaction. 2) Music therapy, which has been effective in clinical trials for anxiety reduction. 3) Cognitive-behavioral therapy (CBT) techniques, including brief cognitive-behavioral audiotape interventions. 4) Guided imagery and progressive muscle relaxation, which have been effective in reducing anxiety in various patient populations. These methods are supported by clinical evidence and can be customized to individual patient needs.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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.

0 / 3Eligibility 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 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.