Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy
NCT ID: NCT03677531
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2018-05-31
2019-09-25
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Other (radiation therapy, videos)
Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo RT
Video
Watch video of choice during RT
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo RT
Video
Watch video of choice during RT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with all tumor types will be included.
Exclusion Criteria
* Patients with underlying movement disorders will be excluded.
3 Years
13 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Oregon Health and Science University
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Jerry Jaboin
Principal Investigator
Principal Investigators
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Jerry J Jaboin
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Other Identifiers
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NCI-2018-01505
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00018053
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00018053
Identifier Type: -
Identifier Source: org_study_id
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