NCT03677531

Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy

VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

This phase I pilot trial studies how well video distraction works to decrease the use of sedation in pediatric participants during radiation therapy. Radiation treatment requires participants to lie very still (for accuracy). Many children cannot do this without sedation. Watching movies during radiation may distract children so they don't need sedation to complete treatment.

Detailed description

PRIMARY OBJECTIVE: I. To determine if the use of video distraction during radiation therapy (VidRT) during radiation for patients ages 3 to 13 decreases the rate of sedation use compared to patients previously treated without VidRT. SECONDARY OBJECTIVE: I. To determine which variables are associated with decreased need for sedation use. Variables will include patient age, length of treatment time (number of treatments and beam-on time), oncologic diagnosis, use of immobilization devices, pre-existing developmental or psychiatric diagnoses (attention deficit hyperactivity disorder \[ADHD\], dissociative disorders \[DD\], anxiety, depression, developmental delay, learning disability), pain scale ratings at time of first radiation treatment (0-10). EXPLORATORY OBJECTIVES: I. To determine the impact of VidRT on patient-reported quality of life prior to starting, during, and at the end of treatment using the pediatric quality of life inventory surveys including the Pediatric Quality of Life Inventory (PedsQL) - 4.0 Core and Peds QL- 3.0 brain tumor questionnaires. II. To determine the impact of VidRT on patient-reported anxiety throughout radiation treatment as monitored by Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric item bank version (v) 2.0 anxiety questionnaire. III. To determine if workup assessment category for patient being low, medium, or high risk of needing sedation correlates to actual sedation use. OUTLINE: Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
RADIATION	Radiation Therapy	Undergo RT
OTHER	Video	Watch video of choice during RT

Timeline

• Start date: 2018-05-31
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2018-09-19
• Last updated: 2020-05-04

Locations

1 site across 1 country: United States