AVATAR Audio-Visual System for Reducing Anesthesia Use

Not currently recruiting at 12 trial locations
AL
Overseen ByAlice Luchen Jiang
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children aged 3-10 undergo radiotherapy without anesthesia. The study uses an audio-visual system, known as Audio-Visual Assisted Therapeutic Ambience in Radiotherapy, to create a calming environment during treatment sessions. Researchers aim to evaluate the system's effectiveness by counting how many children can complete at least one treatment session without anesthesia. Children who speak English or Spanish, are receiving radiotherapy, and do not have eye-related cancers may be suitable for this trial.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of children, offering a chance to benefit from innovative care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What prior data suggests that the AVATAR audio-visual system is safe for patients?

Research has shown that the AVATAR system is promising in terms of safety. In one study, it reduced the need for anesthesia during radiation therapy for children, indicating good tolerance. Another study found that AVATAR eliminated the need for anesthesia in 78% of children aged 3 to 10, outperforming similar past cases.

These findings are encouraging because avoiding anesthesia reduces risks for children. Overall, the evidence supports AVATAR as a safe option for helping children remain calm and still during treatment.12345

Why are researchers excited about this trial?

Researchers are excited about using Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) for pediatric patients because it offers a non-invasive alternative to anesthesia during radiotherapy sessions. Unlike traditional anesthesia, which can have side effects and requires recovery time, AVATAR uses engaging audiovisual tools to help children stay calm and still during treatment. This method could reduce the need for sedatives, minimize the risks associated with anesthesia, and make the whole experience less stressful for young patients and their families.

What evidence suggests that the AVATAR audio-visual system is effective for reducing the need for anesthesia?

Research has shown that the AVATAR system, which participants in this trial will experience, can help children undergo radiation therapy without anesthesia. In one study, 92% of children completed their radiation sessions without anesthesia when using AVATAR. Another study found a 16% reduction in anesthesia use with this system. AVATAR employs sights and sounds to keep children calm and still during treatment. It has effectively made radiation therapy easier and less stressful for young patients.25678

Who Is on the Research Team?

SM

Susan M Hiniker

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy Treatment

Participants undergo radiotherapy sessions using the AVATAR audio-visual system to reduce the need for anesthesia

24 months

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Audio-Visual Assisted Therapeutic Ambience in Radiotherapy

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Audio-Visual Assisted Therapeutic Ambience in RadiotherapyExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Use of Audiovisual Assisted Therapeutic Ambience in ...

Conclusions. The AVATAR system was effective in eliminating the need for anesthesia during radiation therapy in a pediatric patient with DS. This demonstrates ...

Integrating Audiovisual Immersion Into Pediatric Radiation ...

The Audiovisual-Assisted Therapeutic Ambience in Radiotherapy (AVATAR) trial was a prospective multicenter study (NCT03991156) examining the combination of ...

Feasibility of the Audio-Visual Assisted Therapeutic ...

A 16% reduction in anesthesia use during RT treatment sessions was observed in patients after AVATAR was introduced compared with prior.

Paediatric radiation therapy without anaesthesia

Audiovisual distraction is a known method to facilitate awake treatment, but its effectiveness at keeping children from moving during treatment ...

Initial clinical outcomes of audiovisual-assisted therapeutic ...

Twenty-three of 25 patients (92%) were able to complete the prescribed course of radiation therapy without anesthesia using the AVATAR system, with a total of ...

Impact of Audiovisual-Assisted Therapeutic Ambience in ...

Impact of Audiovisual-Assisted Therapeutic Ambience in Radiation Therapy (AVATAR) on Anesthesia Use, Payer Charges, and Treatment Time in ...

Feasibility of the Audio-Visual Assisted Therapeutic ...

In this 10-center prospective trial, anesthesia avoidance with AVATAR was 78% in children aged 3 to 10 years, higher than among age-matched historical controls.

AVATAR Anesthesia Alternative in Pediatric Radiotherapy ...

Device : Audio-Visual Assisted Therapeutic Ambience in Radiotherapy. Audio Visual System. Other Names: AVATAR. Other : Quality of Life Survey, PedsQL3.0.