Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Brooke Army Medical Center

Status: Unknown

Conditions: Perioperative Care; Procedural Anxiety; Procedural Pain

Treatments: Procedure: Peripheral intravenous catheter placement; Device: Virtual reality

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03740607

c.2017.114d

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Virtual reality during PIV placement

Experimental group

Description:

Randomized consented adult subjects will participate in a six-minute healthcare virtual reality software program via Samsung Gear virtual reality headsets while receiving 18 or 20-gauge peripheral intravenous catheter placement in peri-operative suite in preparation for surgery. They will be asked to rate their pain and discomfort afterwards using a graphic rating scale. They will be asked several questions about satisfaction, in order to elicit clinical significance of this intervention. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.

Treatment:

Device: Virtual reality

Procedure: Peripheral intravenous catheter placement

Standard PIV placement

Placebo Comparator group

Description:

Adult control arm subjects will receive 18 or 20-gauge peripheral intravenous catheter placement according to current standard protocol, without virtual reality distraction .They will be asked to rate pain and discomfort afterwards using a graphic rating scale. Demographic information will be collected, and baseline vital signs upon arrival to OR will be abstracted retrospectively.

Treatment:

Procedure: Peripheral intravenous catheter placement