Virtual Reality Experiences on Acute Pain and Distress

Study Overview
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Brief Summary
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The aim of this study is to evaluate the efficacy of virtual reality experiences on acute pain and distress caused by fluoroscopic pain intervention in chronic pain patient.

Detailed Description
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The investigators perform lots of interventions for patients. But unfortunately, patients cannot help being exposed to the acute pain and fear during the interventions. Virtual Reality(VR) is a state-of-art advanced technology, which is now being extended to various medical fields such as pain management, dental treatment, body rehabilitation and cancer pain. There is no study that have conjugated the virtual reality experience for patients' acute pain and anxiety which occurs during the pain interventions. So the investigators like to evaluate the effects of virtual reality experience on acute pain and anxiety precipitated by the pain interventions.

Official Title
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The Efficacy of Virtual Reality Experiences on Acute Pain and Distress Caused by Fluoroscopic Pain Intervention in Chronic Pain Patients - A Randomized Controlled Clinical Trial

Conditions
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Virtual Reality, Acute Pain, Anxiety

Intervention / Treatment
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* Device: Virtual reality group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: If all of the following conditions are met : Patient who has chronic pain lasting more than 3 months and whose pain doctor determined that he or she needs following fluoroscopic pain intervention : Lumbar sympathetic ganglion block (LSGB), Fluoroscopic-guided pulsed radiofrequency ablation (pRF), Fluoroscopic-guided radiofrequency thermocoagulation (hRF) Adults who are at least 20 years of age Patients whose American Society of Anesthesiologists(ASA) physical status is classified as 1 or 2. A person who voluntarily agrees to participate in this clinical trial and has agreed in informed consent. Exclusion Criteria: If the subject falls under any of the following conditions : Patients who cannot have virtual reality experience due to hearing or visual impairment If the patient has difficulty communicating due to lack of cognitive ability Patients that examiners deemed unsuitable for this trial

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality group<br>After experiencing the VR machine in the transfer bed for 5 minutes, the subject moves to the operating room. After the subject moves to the surgical bed, he/she takes the appropriate position for the fluoroscopic pain intervention, and wears the virtual reality device (headset, headphone, smartphone). After the subject starts the VR program, the practitioner starts the fluoroscopic pain intervention. Lidocaine skin infiltration and description of the practitioner during the intervention are performed with the intervention when necessary. | Device: Virtual reality group<br>* Virtual reality group The study intervention is to provide acute pain management for the subject undergoing fluoroscopic pain intervention by using the virtual reality program provided by the collaborator through virtual reality device (headset, headphone, and smartphone) that are commercialized on the market.<br>* Other names: Experimental;|
| No Intervention: Conventional group<br>The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point scale pain score | 11-point scale pain score was assessed by the patient during the fluoroscopic-guided intervention, 0-10. 0 means no pain, 10 means the most severe pain one can imagine | 15min after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety rating score (HAM-A) | total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 15min after the procedure | 
| Net Promotor Score (NPS) by patient | On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague | 15min after the procedure | 
| Net Promotor Score (NPS) by physician | On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague | 15min after the procedure | 
| Total amount of local anesthetics used to skin infiltration | Total amount of local anesthetics used to skin infiltration (ml) | intraoperative | 
| Total procedural time | Total procedural time (minute) | intraoperative | 
| Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%) | Percutaneous oxygen saturation(SPO2,%) | Intraoperative | 
| Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg) | noninvasive blood pressure(NIBP, mm Hg) | Intraoperative | 
| Vital sign of the patient: electrocardiogram(ECG) | Arrhythmia | Intraoperative | 
| Vital sign of the patient: Heart rate (beat per minute) | Heart rate (beat per minute) | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Acute pain, Anxiety