Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Virtual reality during PIV 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. |
Device: Virtual reality
Healthcare virtual reality software implemented during peripheral intravenous catheter placement
Other Names:
Procedure: Peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Other Names:
|
| Placebo Comparator: Standard PIV 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. |
Procedure: Peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
- 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
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brooke Army Medical Center | San Antonio | Texas | United States | 78234 |
Sponsors and Collaborators
- Brooke Army Medical Center
Investigators
- Study Director: Christopher Maani, MD, BAMC Faculty
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12.
- 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.
- Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents.
- Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599. Review.
- Kenney MP, Milling LS. The effectiveness of virtual reality distraction for reducing pain: a meta-analysis. Psychology of Consciousness: Theory, Research, and Practice 3(3): 199-210, 2016.
- Maani CV, Hoffman HG, Fowler M, Maiers AJ, Gaylord KM, Desocio PA. Combining ketamine and virtual reality pain control during severe burn wound care: one military and one civilian patient. Pain Med. 2011 Apr;12(4):673-8. doi: 10.1111/j.1526-4637.2011.01091.x. Epub 2011 Apr 11.
- Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2.
- Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13. Review.
- Rosen LD, Whaling K, Carrier LM, Cheever NA, Rokkum J. The Media and Technology Usage and Attitudes Scale: An empirical investigation. Comput Human Behav. 2013 Nov 1;29(6):2501-2511.
- Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
- c.2017.114d