Virtual Reality Distraction During Pediatric Intravenous Line Placement

NCT03304769 | Unknown

• 1 other identifier: ASalinas
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.

Conditions

Pediatric IV Placement; Virtual Reality Distraction

Keywords

Virtual Reality Distraction; Pediatric IV placement

Outcome Measures

Primary Outcomes (1)

• Successful IV placement with first attempt

  success in first attempt in VR group vs non VR group

  6 months

Secondary Outcomes (7)

• number of attempts before successfully establishing IV

  6 months

• time to establishing successful IV

  6 months

• Pre vs Post FACES revised pain scale parents

  6 months

• Pre vs Post FACES revised pain Scale patients

  6 months

• Pre vs Post Likert-Type Anxiety Scale - parents

  6 months

Study Arms (2)

IV placement no Virtual reality

NO INTERVENTION

Patient will have IV placed in traditional manner, with no virtual reality headset

IV placement with Virtual Reality

EXPERIMENTAL

Patient will have IV placed with Virtual Reality headset distraction

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.

IV placement with Virtual Reality

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patient aged 4-17 years
• Requiring IV placement
• Child Life unavailable

You may not qualify if:

• Previous enrollment in the study
• Physically/ developmentally unable to tolerate headset
• Skin/eye pathology
• Critically ill patient
• Language other than English or Spanish
• Student Nurse placing IV

Sponsors & Collaborators

• University of Texas at Austin: lead
• Seton Healthcare Family: collaborator

Study Sites (1)

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

Central Study Contacts

Anna K Schlechter, MD

CONTACT

512-662-6512; anna.schlechter@gmail.com

Matthew Wilkinson, MD

CONTACT

512-547-8362; mhwilkinson@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Selected from a single-site level one pediatric emergency department. Pediatric patients aged 4-17 years requiring an IV. Random number generator used to decide which patients will be using VR and which will have standard IV placement

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 9, 2017
• Study Start: September 28, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)