AnesthesiaNCT03991156
AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
An observational study of Anesthesia, run by Stanford University at 11 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Audio-Visual Assisted Therapeutic Ambience in Radiotherapy, Quality of Life Survey, PedsQL3.0 and Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 11 sitesUnited States
- Study dates
- 28 May 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.
Who may be able to join
- Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
- The patient must speak English or Spanish.
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Indiana University
Bloomington, Indiana, 47405
Dana Farber Cancer Institute/Brigham & Women Children Hospital
Boston, Massachusetts, 02215
University North Carolina
Chapel Hill, North Carolina, 27599
Cincinnati Children's/UC Health Proton Therapy Center
Cincinnati, Ohio, 45229
St. Jude Children Hospital
Memphis, Tennessee, 38105
University of Minnesota
Minneota, Minnesota, 55455
Oregon Health and Science University
Portland, Oregon, 97239
University of Rochester School of Medicine
Rochester, New York, 14642
St. Louis Children's Hospital
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94304
About this 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.
- Conditions
- Anesthesia
- Being tested
- Audio-Visual Assisted Therapeutic Ambience in Radiotherapy, Quality of Life Survey, PedsQL3.0, Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)
- Keywords
- Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-Visual Assisted Therapeutic Ambience in RadiotherapyDevice
Also called AVATAR
Audio Visual System
Quality of Life Survey, PedsQL3.0Other
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
| Study group | Role | What they receive |
|---|---|---|
| Audio-Visual Assisted Therapeutic Ambience in Radiotherapy | Not described Receives: Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy; Other: Quality of Life Survey, PedsQL3.0; Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of AVATAR system
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.
Measured: 24 months
Secondary outcomes (6)
Measure Fractional Success using AVATAR system
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.
Measured: 24 months
Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.
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.
Measured: 24 months
Compare the rates of anesthesia with historical controls
Compare the rates of anesthesia use between patients using AVATAR to historical controls who were not introduced to AVATAR.
Measured: 24 months
Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR
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.
Measured: 24 months
Difference in health quality of life between subjects with or without anesthesia
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)
Measured: 24 months
Assess predictability for AVATAR patient success
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start28 May 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan M Hiniker, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991156
- Sponsor's protocol ID
- IRB-47864
- Other IDs
- PEDSVAR0050, NCI-2019-06417
- Status last verified
- Apr 2026
- First submitted
- 12 Jun 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37001762
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVATAR Anesthesia Alternative in Pediatric Radiotherapy: A Multi-Center Study
- ClinicalTrials.gov ID
- NCT03991156
- Acronym / sponsor ID
- IRB-47864
- Conditions
- Anesthesia
- Keywords
- Radiotherapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Audio-Visual Assisted Therapeutic Ambience in Radiotherapy | – | Device: Audio-Visual Assisted Therapeutic Ambience in Radiotherapy, Other: Quality of Life Survey, PedsQL3.0, Other: Yale Preoperative Anxiety Scale Short Form (mYPAS-SF) |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The age range of patients is 3-10 years old, and there is no discrimination on ethnic background in recruitment for this study.
Key inclusion criteria (2 listed)
- Pediatric patients ages 3-10 receiving radiotherapy qualify for enrollment.
- The patient must speak English or Spanish.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-Visual Assisted Therapeutic Ambience in RadiotherapyAlso: AVATARAudio Visual System | Device | Audio-Visual Assisted Therapeutic Ambience in Radiotherapy |
| Quality of Life Survey, PedsQL3.0Quality of life survey using the PedsQL 3.0 Cancer Module | Other | Audio-Visual Assisted Therapeutic Ambience in Radiotherapy |
| Yale Preoperative Anxiety Scale Short Form (mYPAS-SF)Yale Preoperative Anxiety Scale Short Form (mYPAS-SF).[24] is a survey to measure anxiety | Other | Audio-Visual Assisted Therapeutic Ambience in Radiotherapy |
Primary outcome
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.
6 secondary outcomes
Measure Fractional Success using AVATAR system
Time frame: 24 months
Determine the difference in patient anxiety between successful AVATAR patients and not-successful patients.
Time frame: 24 months
Compare the rates of anesthesia with historical controls
Time frame: 24 months
Determine the rate at which patients convert from requiring anesthesia to not requiring anesthesia while using AVATAR
Time frame: 24 months
Difference in health quality of life between subjects with or without anesthesia
Time frame: 24 months
Assess predictability for AVATAR patient success
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 37001762Gutkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Hiniker principal investigator
Stanford University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Stanford University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of AVATAR system (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03991156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.