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NCT05148078 · ClinicalTrials.gov registry record · Phase 2
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT05148078: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT05148078 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05148078, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
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%.
Primary Outcome
To change the total number of pediatric patients who require general anesthesia through the use of PROMISE.
Interventions
- OTHER PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2024-11-26 |
| Phase | Phase 2 |
What the finished NCT05148078 record still lists
NCT05148078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) is the first listed.
NCT05148078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05148078 about?
NCT05148078 is a clinical study titled "Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE)". 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,...
What is the current status of trial NCT05148078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-08-01. Estimated completion is 2024-11-26.
What interventions are being tested in trial NCT05148078?
The interventions under investigation include: PROMISE (Pediatric Radiation Oncology with Movie Induced Sedation Effect) (OTHER).
Who is sponsoring clinical trial NCT05148078?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05148078's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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