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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 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants.
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%.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05148078
The ClinicalTrials.gov registry entry for NCT05148078 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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