Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
- Conditions
- Procedural PainProcedural AnxietyPerioperative Care
- Interventions
- Device: Virtual realityProcedure: Peripheral intravenous catheter placement
- Registration Number
- NCT03740607
- Lead Sponsor
- Brooke Army Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtual reality during PIV placement Peripheral intravenous catheter placement 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. Standard PIV placement Peripheral intravenous catheter placement 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. Virtual reality during PIV placement Virtual reality 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.
- Primary Outcome Measures
Name Time Method Discomfort associated with peripheral IV placement 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 Outcome Measures
Name Time Method Claustrophobia This outcome will be measured immediately after peripheral IV placement The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement
Clinical significance This outcome will be measured immediately after peripheral IV placement the subject will be asked if they would want to have their IV placed this way again
Degree to which subject felt immersed in virtual reality This outcome will be measured immediately after peripheral IV placement The subject will answer a question regarding the extent to which they felt they went "inside" the computer-generated world
Nausea This outcome will be measured immediately after peripheral IV placement Subject will answer a question regarding extent to which nausea was experienced during IV placement
Satisfaction score This outcome will be measured immediately after peripheral IV placement The subject will be asked if they were satisfied with 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 Baseline vital signs- continuous variables
Fun factor This outcome will be measured immediately after peripheral IV placement Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10
Magnitude of pain severity This outcome will be measured immediately after peripheral IV placement Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points
Time spent thinking about pain This outcome will be measured immediately after peripheral IV placement Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.
Trial Locations
- Locations (1)
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States