AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study

NCT ID: NCT03991156

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2026-12-31

Brief Summary

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To determine the success rate of the AVATAR audio-visual system. All patients enrolled in the study will be counted, and each patient who is able to undergo at least one fraction without anesthesia will count as a success while each patient who does not have at least one fraction without anesthesia will count as a failure. The success rate will be the proportion of patients who are successes.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Audio-Visual Assisted Therapeutic Ambience in Radiotherapy

Audio-Visual Assisted Therapeutic Ambience in Radiotherapy

Intervention Type DEVICE

Audio Visual System

Quality of Life Survey, PedsQL3.0

Intervention Type OTHER

Quality of life survey using the PedsQL 3.0 Cancer Module

Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)

Intervention Type OTHER

Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).\[24\] is a survey to measure anxiety

Interventions

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Audio-Visual Assisted Therapeutic Ambience in Radiotherapy

Audio Visual System

Intervention Type DEVICE

Quality of Life Survey, PedsQL3.0

Quality of life survey using the PedsQL 3.0 Cancer Module

Intervention Type OTHER

Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)

Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).\[24\] is a survey to measure anxiety

Intervention Type OTHER

Other Intervention Names

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AVATAR

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
* The patient must speak English or Spanish.

Exclusion Criteria

* If parent/guardian is unable to take part in helping to complete questionnaires
* Patients with malignancies of the eye for which radiation is planned
* Patients that do not speak English or Spanish
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan M Hiniker

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Indiana University

Bloomington, Indiana, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute/Brigham & Women Children Hospital

Boston, Massachusetts, United States

Site Status

University of Minnesota

Minneota, Minnesota, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

University of Rochester School of Medicine

Rochester, New York, United States

Site Status

University North Carolina

Chapel Hill, North Carolina, United States

Site Status

Cincinnati Children's/UC Health Proton Therapy Center

Cincinnati, Ohio, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

St. Jude Children Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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Gutkin PM, Skinner L, Jiang A, Donaldson SS, Loo BW Jr, Oh J, Wang YP, von Eyben R, Snyder J, Bredfeldt JS, Breneman JC, Constine LS, Faught AM, Haas-Kogan D, Holmes JA, Krasin M, Larkin C, Marcus KJ, Maxim PG, McClelland S 3rd, Murphy B, Palmer JD, Perkins SM, Shen CJ, Terezakis S, Bush K, Hiniker SM. Feasibility of the Audio-Visual Assisted Therapeutic Ambience in Radiotherapy (AVATAR) System for Anesthesia Avoidance in Pediatric Patients: A Multicenter Trial. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):96-104. doi: 10.1016/j.ijrobp.2023.03.063. Epub 2023 Mar 30.

Reference Type DERIVED
PMID: 37001762 (View on PubMed)

Other Identifiers

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PEDSVAR0050

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-47864

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-47864

Identifier Type: -

Identifier Source: org_study_id

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