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NCT Number: NCT03991156

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anesthesia

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Stanford, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio-Visual Assisted Therapeutic Ambience in Radiotherapy

Device

Audio Visual System

Other names: AVATAR

Quality of Life Survey, PedsQL3.0

Other

Quality of life survey using the PedsQL 3.0 Cancer Module

Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)

Other

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

Primary outcomes

  1. Success rate of AVATAR system

    Time frame: 24 months

    Success rate will be determined as the proportion of patients who are successes.

    Success will be counted as each patient who is able to undergo at least one fraction without anesthesia while each patient who does not have at least one fraction without anesthesia will count as a failure.

Secondary outcomes

  1. Measure Fractional Success using AVATAR system

    Time frame: 24 months

    Fractional Success will be is counted as a fraction in which the patient does not require anesthesia will count as a fractional success, while a fraction in which the patient required anesthesia will be a fractional failure.

  2. Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.

    Time frame: 24 months

    The difference in patient anxiety between successful AVATAR patients and not-successful patients will be determined. Anxiety will be assesed by modified Yale Preoperative Anxiety Survey Short Form (mYPAS-SF). mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.

  3. Compare the rates of anesthesia with historical controls

    Time frame: 24 months

    Compare the rates of anesthesia use between patients using AVATAR to historical controls who were not introduced to AVATAR.

  4. Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR

    Time frame: 24 months

    The rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR will be determined. Conversion is determined by the fraction at which the patient switches from using anesthesia to not using anesthesia.

  5. Difference in health quality of life between subjects with or without anesthesia

    Time frame: 24 months

    The difference between family-reported health-related quality of life between patients who were able to tolerate treatment without anesthesia using the AVATAR program and patients who required anesthesia for the entire treatment. The quality of life will be measured using Pediatric oncology quality of life inventory 3.0-cancer module (PedsQL 3.0 Cancer Module)

  6. Assess predictability for AVATAR patient success

    Time frame: 24 months

    AVATAR patient success will be determined by using the predictability of the PedsQL3.0 Cancer and modified Yale Preoperative Assessment Survey Short Form (mYPAS-SF) questionnaires. mYPAS-SF measurement instrument uses 5 items, each representing a different domain of child anxiety, and is used at 4 points in time.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2019
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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