Clinical trial NCT03740607: Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Official title: Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Anxiety
Procedural Pain
Perioperative Care
Keywords: Adult
Peripheral IV
procedural pain
procedural anxiety
virtual reality
peripheral intravenous catheter
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2018-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: randomized prospective cohort
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Discomfort associated with peripheral IV placement
timeFrame: This outcome will be measured immediately after peripheral IV placement
Secondary outcomes:
measure: Magnitude of pain severity
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Time spent thinking about pain
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Degree to which subject felt immersed in virtual reality
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Nausea
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Claustrophobia
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Clinical significance
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Satisfaction score
timeFrame: This outcome will be measured immediately after peripheral IV placement
measure: Physiological parameters
timeFrame: 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
measure: Fun factor
timeFrame: This outcome will be measured immediately after peripheral IV placement
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: BAMC Faculty
name: Christopher Maani, MD
role: STUDY_DIRECTOR
References:
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citation: Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain. 2008 May;24(4):299-304. doi: 10.1097/AJP.0b013e318164d2cc.
citation: Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. doi: 10.1097/00000542-199710000-00021.
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