Procedural Pain Clinical Trial
Official title:
Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | September 15, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Satisfaction score | The subject will be asked if they were satisfied with IV placement | This outcome will be measured immediately after peripheral IV placement | |
Secondary | 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 | |
Secondary | 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 |
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