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临床试验/NCT03334929
NCT03334929已完成不适用

Virtual Reality Distraction for Anxiety Reduction During Trigger Points Procedures in Pain Medicine Clinic

University of California, Davis1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2017年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
1
主要终点
Change in anxiety level

研究概览

简要总结

This study aims to evaluate the effect of Virtual Reality (VR) as a distraction method to help those patients undergoing trigger points therapy to reduce anxiety and increase patient satisfaction. Half of the participants will wear VR gear, meanwhile the other half will be in control group, which will not wear VR headset, only the normal care.

详细描述

trigger points can cause a wide range of pain symptoms; pain in the anterior shoulder and down the arm, headache pain, back pain, hip pain, knee pain, frozen shoulder pain, and other symptoms. Local anesthetic injections and lidocaine injections are common "wet" needling treatments for trigger points injections. The proposed mechanism by which trigger points injections alleviate pain is based on mechanical disruption of the taut bands of muscle with palpation based needling. During injections, patients may feel an intensified pain and a twitch response.

Distraction has been proved to be an effective tool in pain management, and it can also be used for a variety of medical procedures. By engaging in assigned tasks, pain and anxiety are assumed to be lessened throughout the procedure, while leaving patients less occupied by pain stimuli. . An immersive virtual environment may be preferable to medications such as sedatives, due to side effects and prolonged discharge from procedure suite. Occasionally, medications may not even be available in a busy interventional pain suite. At the UCD pain clinic, we do not offer sedating medications for bedside procedures like trigger point injections. By wearing VR headset, patients may feel less tense, anxious, and painful during trigger point injections.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients aged over 18 years old, who are referred to UC Davis Pain Medicine Clinic and are candidates for trigger point injections, are English speaking and can understand oral and written instructions

排除标准

  • •Patients who have high risk of motion sickness, seizure disorder, visual/hearing impairment, prisoners or are pregnant are not eligible for this study.

研究组 & 干预措施

Virtual Reality intervention

Experimental

Participants will be wearing Virtual Reality headset called Oculus gear equipped with Samsung galaxy S7 during the trigger point injections. The VR app chosen is called Relax VR - Rest, Relaxation & Meditation, which will provide a calm beach scene with waves and soothing musics.

干预措施: Virtual Reality headset (Device)

control

No Intervention

Participants in this group will receive trigger point injections without any intervention. The trigger point injections will be performed in daily manner.

结局指标

主要结局

Change in anxiety level

时间窗: Immediately pre- and post-procedure

Spielberger State-Trait Anxiety Inventory items measuring state anxiety. All items are rated on a 4-point scale, with higher scores indicating greater anxiety.

次要结局

  • Change in pain score(Immediately pre- and post-procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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