Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Conditions
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Procedural Anxiety, Procedural Pain, Perioperative Care

Intervention / Treatment
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* Device: Virtual reality
* Procedure: Peripheral intravenous catheter placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: randomized prospective cohort
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality during PIV placement<br>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. | Device: Virtual reality<br>* Healthcare virtual reality software implemented during peripheral intravenous catheter placement<br>* Other names: Samsung Gear Headset, AppliedVR software;Procedure: Peripheral intravenous catheter placement<br>* Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.<br>* Other names: PIV;|
| Placebo Comparator: Standard PIV placement<br>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. | Procedure: Peripheral intravenous catheter placement<br>* Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.<br>* Other names: PIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort associated with 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. | This outcome will be measured immediately after peripheral IV placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnitude of pain severity | Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points | This outcome will be measured immediately after peripheral IV placement | 
| Time spent thinking about pain | Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion. | This outcome will be measured immediately after peripheral IV placement | 
| Degree to which subject felt immersed in virtual reality | The subject will answer a question regarding the extent to which they felt they went inside the computer-generated world | This outcome will be measured immediately after peripheral IV placement | 
| Nausea | Subject will answer a question regarding extent to which nausea was experienced during IV placement | This outcome will be measured immediately after peripheral IV placement | 
| Claustrophobia | The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement | This outcome will be measured immediately after peripheral IV placement | 
| Clinical significance | the subject will be asked if they would want to have their IV placed this way again | This outcome will be measured immediately after peripheral IV placement | 
| Satisfaction score | The subject will be asked if they were satisfied with IV placement | This outcome will be measured immediately after peripheral IV placement | 
| Physiological parameters | Baseline vital signs- continuous variables | 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 | Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10 | This outcome will be measured immediately after peripheral IV placement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult, Peripheral IV, procedural pain, procedural anxiety, virtual reality, peripheral intravenous catheter