Virtual Reality Distraction During Pediatric Intravenous Line Placement

NCT ID: NCT03304769

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-28
• Study Completion Date: 2018-01-31

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.

Detailed Description

Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

IV placement no Virtual reality

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

IV placement with Virtual Reality

Patient will have IV placed with Virtual Reality headset distraction

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

Interventions

Virtual Reality

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seton Healthcare Family

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna K Schlechter, MD

Role: CONTACT

Phone: 512-662-6512

Email: anna.schlechter@gmail.com

Matthew Wilkinson, MD

Role: CONTACT

Phone: 512-547-8362

Email: mhwilkinson@ascension.org

Facility Contacts

Matthew Wilkinson, MD

Role: primary

Other Identifiers

ASalinas

Identifier Type: -

Identifier Source: org_study_id