VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Rate of sedation use calculated using number of treatment sessions
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All races and genders will be included.
- •Patients with all tumor types will be included.
Exclusion Criteria
- •Patients < 3 years and > 13 years of age will be excluded.
- •Patients with underlying movement disorders will be excluded.
Arms & Interventions
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Intervention: Questionnaire Administration (Other)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Intervention: Radiation Therapy (Radiation)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Intervention: Video (Other)
Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Intervention: Quality-of-Life Assessment (Other)
Outcomes
Primary Outcomes
Rate of sedation use calculated using number of treatment sessions
Time Frame: Up to 1 year
A 1-sided binomial test will be used.
Secondary Outcomes
- Number of treatments and association with decreased sedation use(Up to 1 year)
- Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use(Up to 1 year)
- Oncologic diagnosis and association with decreased sedation use(Up to 1 year)
- Use of immobilization device and association with decreased sedation use(Up to 1 year)
- Patient age and association with decreased sedation use(Up to 1 year)
- Beam "on-time" and association with decreased sedation use(Up to 1 year)
- Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)(Up to 1 year)
Investigators
Jerry Jaboin
Principal Investigator
OHSU Knight Cancer Institute