NCT05148078CompletedPhase 2
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE): A Phase II Clinical Trial to Safely Reduce Anesthesia Use
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) is an interactive incentive-based movie system that integrates with a video surveillance gating module (VisionRT) as an alternative sedation solution for pediatric patients undergoing radiation treatment (RT). This single-arm, open label, single-center phase II clinical trial is to implement PROMISE for all children ages 3-11 who are planned to undergo RT at the institution. The primary goal is to decrease the total number of pediatric patients who require general anesthesia through the use of PROMISE, with secondary goals being to assess the impact that PROMISE has on patient/family anxiety and quality of life, treatment time and clinical efficiency, and overall cost. The investigators hypothesize that PROMISE will lead to a reduction in the percentage of patients ages 3-7 who require general anesthesia use from 70% (historical control) to 30%.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 28 Oct 2021
- Start date
- 1 Aug 2022
- Primary completion date
- 14 Oct 2024
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Childhood cancers
- NCT number
- NCT05148078
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 1 Aug 2022 to the primary completion date, 14 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Subjects with documented medical behavior conditions or other conditions necessitating anesthesia use
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Other
- Subjects whose parents opt to not include them (the subject) in the clinical trial.
Who the study is looking for
- Planned to undergo radiation treatment
- Age 3-11 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening
- Parents or guardians with the ability to understand and the willingness to sign a written informed consent.
Age in the registry: 3 years to 11 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.