Acute Pain, Anxiety, Virtual Reality
Conditions
Keywords
Virtual reality, Acute pain, Anxiety
Brief summary
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
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.
Interventions
DEVICEVirtual reality group
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.
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 11-point scale pain score | 15min after the procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net Promotor Score (NPS) by patient | 15min after the procedure | On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague |
| Net Promotor Score (NPS) by physician | 15min after the procedure | On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague |
| Total amount of local anesthetics used to skin infiltration | intraoperative | Total amount of local anesthetics used to skin infiltration (ml) |
| Total procedural time | intraoperative | Total procedural time (minute) |
| Hamilton Anxiety rating score (HAM-A) | 15min after the procedure | total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. |
| Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg) | Intraoperative | noninvasive blood pressure(NIBP, mm Hg) |
| Vital sign of the patient: electrocardiogram(ECG) | Intraoperative | Arrhythmia |
| Vital sign of the patient: Heart rate (beat per minute) | Intraoperative | Heart rate (beat per minute) |
| Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%) | Intraoperative | Percutaneous oxygen saturation(SPO2,%) |
Countries
South Korea
Outcome results
None listed