NCT03740607

Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.

Detailed description

This is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral IV (PIV) placement. Adult patients who require PIV placement for elective surgery will be consented for intervention while in the peri-operative suites (PS). The VR intervention will consist of a headset and immersive VR software that allows the patient to engage in a virtual world during PIV placement. Subjects will be queried immediately after PIV placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with PIV placement (Appendix A). They will also be asked two validated questions concerning patient satisfaction (Dexter et al 1997). A control group of patients will undergo a similar assessment with slightly different wording after receiving PIV placement without iVR.

Conditions

• Procedural Anxiety
• Procedural Pain
• Perioperative Care

Interventions

Type	Name	Description
DEVICE	Virtual reality	Healthcare virtual reality software implemented during peripheral intravenous catheter placement
PROCEDURE	Peripheral intravenous catheter placement	Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-09-01
• Completion: 2022-09-15
• First posted: 2018-11-14
• Last updated: 2021-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study