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Comparison of Virtual Reality to Tablet-based Distraction in Children

NCT04414501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-03-15

No results posted yet for this study

Summary

The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

Conditions

  • Anxiety, Separation

Interventions

BEHAVIORAL

Separation Anxiety

Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Elizabeth Ghazal, MD · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2020-04-02
Completion
2020-04-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414501 on ClinicalTrials.gov