Assessing the Impact of Immersive Virtual Reality Experience on Injection-related Anxiety in Patients Undergoing Interventional Pain Spine Procedures: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Numeric rating score for anxiety when local anesthetic is injected.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old at day of enrollment
- •Neck pain patient deemed to be a candidate for pain control treatment with interventional fluoroscopically guided cervical epidural steroid injection as determined by their pain medicine provider based on history, physical exam, and radiographic findings
- •Willingness to undergo pre-procedural intervention of VR viewing experience or equivalent pre-procedural wait time
- •No history of prior epidural steroid injections
- •Did not receive sedatives prior to or during procedure
排除标准
- •Refusal / inability to participate or provide consent
- •Contraindications to injection (anticoagulated states, allergy to components of injection, local infection at injection site, current infectious process or treatment of antibiotics for current infection)
- •Uncontrolled anxiety disorder or untreated/inadequately treated psychiatric disorder
- •History of Alzheimer's, dementia, or cognitive dysfunction
- •Patient currently taking benzodiazepines
- •Severe motion sickness
- •Seizure disorder
- •Vision loss
- •Non-English speaking patients
研究组 & 干预措施
Group 2 control group
Group 2 control group has no preprocedural intervention. Standard clinic waiting conditions for 15-20 minutes before their planned pain clinic procedure.
干预措施: Group 2 Control Group (Other)
Group 1 Immersive Virtual Reality (VR)
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.
干预措施: Group 1 Immersive Virtual Reality (VR) (Other)
结局指标
主要结局
Numeric rating score for anxiety when local anesthetic is injected.
时间窗: Start of planned procedure
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.
Numeric rating score for anxiety while positioning on the fluoroscopy table.
时间窗: Before planned procedure
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.
Numeric rating score for anxiety when the epidural needle is removed.
时间窗: End of planned procedure
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
次要结局
- Timepoint at peak of numeric rating score anxiety rating(Through study completion average of 2 hours)
- Procedural pain during epidural steroid injection reported by participants.(During planned procedure)
研究者
Jason Ross
Principal Investigator
Northwestern University