Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 3 - 13 |
| Updated: | 9/21/2018 |
| Start Date: | May 31, 2018 |
| End Date: | July 31, 2019 |
VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
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.
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.
PRIMARY OBJECTIVES:
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 OBJECTIVES:
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 the impact of VidRT on parent-report of family experiences throughout
treatment as reported with PedsQL family impact module questionnaire.
IV. To determine if workup assessment category for patient being low, medium, or high risk of
needing sedation correlates to actual sedation use.
V. To determine correlation of parent-reported preexisting patient behavior with sedation use
as reported using 13-question assessment from Ashbury et al.
OUTLINE:
Participants undergo daily radiation therapy and watch videos/movies of their choice during
treatments.
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 OBJECTIVES:
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 the impact of VidRT on parent-report of family experiences throughout
treatment as reported with PedsQL family impact module questionnaire.
IV. To determine if workup assessment category for patient being low, medium, or high risk of
needing sedation correlates to actual sedation use.
V. To determine correlation of parent-reported preexisting patient behavior with sedation use
as reported using 13-question assessment from Ashbury et al.
OUTLINE:
Participants undergo daily radiation therapy and watch videos/movies of their choice during
treatments.
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.
- Patients receiving total body irradiation will not be included as this involves a
different treatment setup position incompatible with our current VidRT equipment.
We found this trial at
1
site
3181 S.W. Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-7999
Principal Investigator: Jerry J. Jaboin
Phone: 503-494-8756
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