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Periprocedural anxiety is a common problem for patients who undergo interventional pain procedures. Virtual Reality (VR) is an immersive experience that has gained acceptance in the medical field as a tool for reducing anxiety and pain for patients.Research Aim:
To evaluate the effect of immersive virtual reality (VR) on periprocedural anxiety related to therapeutic cervical epidural steroid injections (ESI).
The investigators hypothesize that immersive virtual reality will result in a clinically meaningful anxiety reduction, defined as the proportion of participants with > 50% reduction in Numeric Rating Scale (NRS) anxiety scores when compared to participants in the non-treatment group who will have standard preprocedural waiting time conditions in clinic, but no VR experience. Similarly, the investigators hypothesize a significant reduction in objective sympathetic tone as measured by skin sympathetic nerve activity (SKNA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Immersive Virtual Reality (VR) | Experimental | Participants in Group 1 Immersive Virtual Reality (VR) will wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure. |
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| Group 2 control group | Placebo Comparator | Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1 Immersive Virtual Reality (VR) | Other | Participants in Group 1 Immersive Virtual Reality (VR) participants wear the device covering their eyes. The viewing experience will include calming nature sounds for between 15-20 minutes before their planned plain clinic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric rating score for anxiety while positioning on the fluoroscopy table. | Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when positioning on the fluroscopy table. | Before planned procedure |
| Numeric rating score for anxiety when local anesthetic is injected. | Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) when local is injected. | Start of planned procedure |
| Numeric rating score for anxiety when the epidural needle is removed. | Numeric rating score for anxiety on an 11-point scale, ranging from 0 (no anxiety at all) to 10 (worst possible level of anxiety) after the epidural needle is removed | End of planned procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural pain during epidural steroid injection reported by participants. | NRS Level of subjective procedural pain during epidural steroid injection recorded by numeric rating score on a scale of 0 (no pain) to 10 (worst pain imaginable) Level of subjective procedural pain during epidural steroid injection recorded by NRS | During planned procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald, RN,BSN,MS | Contact | 312-695-1064 | p-fitzgerald2@northwestern.edu | |
| Jason Ross, MD | Contact | 312-695-0061 | jason.ross@nm.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason Ross, MD | Northwestern Univesity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesiology Pain Medicine Center | Recruiting | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Randomized controlled observational trial
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| Group 2 Control Group | Other | Group 2 control group participants have no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure. |
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| Timepoint at peak of numeric rating score anxiety rating | Timepoint at peak numeric rating score for anxiety (NRS) 0 (no anxitey) to 10 (worst anxiety). | Through study completion average of 2 hours |