MedTrace Logo

VR Usage in Non-Invasive Surgical Sub-Specialty Procedures

NCT03464955 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 291

Last updated 2023-09-28

No results posted yet for this study

Summary

Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.

Conditions

  • Stress, Emotional
  • Stress, Psychological
  • Behavioral Symptoms

Interventions

BEHAVIORAL

Technology Based Distractions

Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)

Sponsors & Collaborators

Principal Investigators

  • Samuel Rodriguez, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2023-06-30
Completion
2023-07-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03464955 on ClinicalTrials.gov