Clinical trial NCT03677531: Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy
Official title: VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Neoplasm
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Oregon Health and Science University
First posted: 2018-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of sedation use calculated using number of treatment sessions
timeFrame: Up to 1 year
Secondary outcomes:
measure: Patient age and association with decreased sedation use
timeFrame: Up to 1 year
measure: Number of treatments and association with decreased sedation use
timeFrame: Up to 1 year
measure: Beam "on-time" and association with decreased sedation use
timeFrame: Up to 1 year
measure: Oncologic diagnosis and association with decreased sedation use
timeFrame: Up to 1 year
measure: Use of immobilization device and association with decreased sedation use
timeFrame: Up to 1 year
measure: Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use
timeFrame: Up to 1 year
measure: Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Jerry J Jaboin
role: PRINCIPAL_INVESTIGATOR
References: