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Clinical Trials/NCT03740607
NCT03740607
Unknown
Not Applicable

Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Brooke Army Medical Center1 site in 1 country100 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Procedural Anxiety
Sponsor
Brooke Army Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Discomfort associated with peripheral IV placement
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
September 15, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Annie Chow

Principal Investigator

Brooke Army Medical Center

Eligibility Criteria

Inclusion Criteria

  • Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.

Exclusion Criteria

  • Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.

Outcomes

Primary Outcomes

Discomfort associated with peripheral IV placement

Time Frame: This outcome will be measured immediately after peripheral IV placement

Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.

Secondary Outcomes

  • Claustrophobia(This outcome will be measured immediately after peripheral IV placement)
  • Clinical significance(This outcome will be measured immediately after peripheral IV placement)
  • Degree to which subject felt immersed in virtual reality(This outcome will be measured immediately after peripheral IV placement)
  • Nausea(This outcome will be measured immediately after peripheral IV placement)
  • Satisfaction score(This outcome will be measured immediately after peripheral IV placement)
  • Physiological parameters(Initial vital signs at start of anesthesia care will be abstracted retrospectively. This reading will likely occur within an hour of the initial intervention, as start times for anesthesia cases are within an hour of initiation of peri-operative care)
  • Fun factor(This outcome will be measured immediately after peripheral IV placement)
  • Magnitude of pain severity(This outcome will be measured immediately after peripheral IV placement)
  • Time spent thinking about pain(This outcome will be measured immediately after peripheral IV placement)

Study Sites (1)

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