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
3 other identifiers
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2019
CompletedMay 4, 2020
April 1, 2020
1.3 years
September 14, 2018
April 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of sedation use calculated using number of treatment sessions
A 1-sided binomial test will be used.
Up to 1 year
Secondary Outcomes (7)
Patient age and association with decreased sedation use
Up to 1 year
Number of treatments and association with decreased sedation use
Up to 1 year
Beam "on-time" 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
- +2 more secondary outcomes
Study Arms (1)
Other (radiation therapy, videos)
EXPERIMENTALParticipants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Interventions
Ancillary studies
Undergo RT
Eligibility Criteria
You may qualify if:
- All races and genders will be included.
- Patients with all tumor types will be included.
You may not qualify if:
- Patients \< 3 years and \> 13 years of age will be excluded.
- Patients with underlying movement disorders will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OHSU Knight Cancer Institutelead
- National Cancer Institute (NCI)collaborator
- Oregon Health and Science Universitycollaborator
Study Sites (1)
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry J Jaboin
OHSU Knight Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 14, 2018
First Posted
September 19, 2018
Study Start
May 31, 2018
Primary Completion
September 25, 2019
Study Completion
September 25, 2019
Last Updated
May 4, 2020
Record last verified: 2020-04