Video Distraction to Decrease Use of Sedation in Pediatric Participants During Radiation Therapy

OHSU Knight Cancer Institute

Status and phase: Completed; Phase 1

Conditions: Malignant Neoplasm

Treatments: Radiation: Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Video

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03677531

NCI-2018-01505 (Registry Identifier)

STUDY00018053 (Other Identifier)

P30CA069533 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Other (radiation therapy, videos)

Experimental group

Description:

Participants undergo daily radiation therapy and watch videos/movies of their choice during treatments.

Treatment:

Other: Video

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Radiation: Radiation Therapy