Using movies to help children relax during radiation treatment
Pediatric Radiation Oncology With Movie Induced Sedation Effect (PROMISE): A Phase II Clinical Trial to Safely Reduce Anesthesia Use
This study is testing if using movies can help kids aged 3-11 relax during radiation treatment and reduce the need for anesthesia.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 11 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05148078 on ClinicalTrials.gov |
What this trial studies
The PROMISE initiative employs an interactive movie system designed to reduce the need for general anesthesia in pediatric patients undergoing radiation therapy. This single-arm, open-label phase II trial targets children aged 3-11, aiming to decrease the percentage of those requiring anesthesia from 70% to 30%. By integrating audiovisual distraction with real-time motion monitoring, the system not only keeps children engaged but also enhances safety during treatment. The study will also evaluate the impact on patient anxiety, quality of life, treatment efficiency, and overall costs associated with radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-11 who are scheduled to undergo radiation treatment for cancer.
Not a fit: Patients with medical behavioral conditions or those requiring anesthesia for compliance will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the reliance on general anesthesia, minimizing associated health risks and costs for pediatric cancer patients.
How similar studies have performed: While audiovisual distraction techniques have been explored, PROMISE represents a novel approach with real-time monitoring that has not been previously tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Planned to undergo radiation treatment 2. Age 3-11 years 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 at screening 4. Parents or guardians with the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Subjects with documented medical behavior conditions or other conditions necessitating anesthesia use 2. 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. 3. Subjects whose parents opt to not include them (the subject) in the clinical trial.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Kiran A Kumar, MD — UT Southwestern Medical Center
- Study coordinator: Jonathan VanPelt
- Email: jonathan.vanpelt@utsouthwestern.edu
- Phone: 214-645-8465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.