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Clinical Trials/NCT03628989
NCT03628989
Completed
Not Applicable

Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures

Stanford University1 site in 1 country58 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Stanford University
Enrollment
58
Locations
1
Primary Endpoint
Measure anxiety score
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
July 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samuel Rodriguez

Professor

Stanford University

Eligibility Criteria

Inclusion Criteria

  • Age 17 and under
  • Able to consent or have parental consent
  • Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities

Exclusion Criteria

  • People who do not consent
  • Significant Cognitive Impairment
  • History of Severe Motion Sickness
  • Current Nausea
  • Visual Problems
  • Non-English Speaking
  • Patients who clinically unstable or requires urgent/emergent intervention
  • (ASA) Physical status classification class 4 or higher
  • Patient or parental preference for General Anesthesia

Outcomes

Primary Outcomes

Measure anxiety score

Time Frame: Duration of procedure (usually no more than 2-4 hours)

Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety

Secondary Outcomes

  • Virtual and Augmented Reality Feedback Survey(Duration of procedure (usually no more than 2-4 hours))
  • Parent and Child Satisfaction Questionnaire(Duration of procedure (usually no more than 2-4 hours))
  • Evaluation of Passive vs Active Interventions(Duration of procedure (usually no more than 2-4 hours))
  • Asses cumulative medication dosing and the duration of procedure(Duration of procedure (usually no more than 2-4 hours))

Study Sites (1)

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