Perioperative Care, Procedural Anxiety, Procedural Pain
Conditions
Keywords
Adult, Peripheral IV, procedural pain, procedural anxiety, virtual reality, peripheral intravenous catheter
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.
Interventions
DEVICEVirtual reality
Healthcare virtual reality software implemented during peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Sponsors
Brooke Army Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized prospective cohort
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactAnnie L Chow, MD, MPH, MS
Backup ContactCheng Yang, MD
Outcome results
None listed