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Completed

NCT Number: NCT03677531

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

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.

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Key information

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

radiation therapy

Radiation

Undergo RT

Other names: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

video

Other

Watch video of choice during RT

Primary outcomes

  1. Rate of sedation use calculated using number of treatment sessions

    Time frame: Up to 1 year

    A 1-sided binomial test will be used.

Secondary outcomes

  1. Patient age and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  2. Number of treatments and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  3. Beam "on-time" and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use

  4. Oncologic diagnosis and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  5. Use of immobilization device and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  6. Pre-existing developmental delay or psychiatric diagnosis and association with decreased sedation use

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

  7. Pain at time of first radiation treatment and association with decreased sedation use (on a scale of one to ten)

    Time frame: Up to 1 year

    A multivariate analysis will be used to determine which variables correlate with increased sedation use.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • Oregon Health and Science University

Registry information

Official study title

VidRT: Video Distraction During Radiation Therapy to Decrease Use of Pediatric Sedation

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
May 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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