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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Virtual Reality
- Sponsor
- Seoul National University
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- 11-point scale pain score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Jeeyoun Moon
Associate professor
Seoul National University
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
11-point scale pain score
Time Frame: 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 Outcomes
- Total amount of local anesthetics used to skin infiltration(intraoperative)
- Vital sign of the patient: Heart rate (beat per minute)(Intraoperative)
- Vital sign of the patient: electrocardiogram(ECG)(Intraoperative)
- Net Promotor Score (NPS) by physician(15min after the procedure)
- Hamilton Anxiety rating score (HAM-A)(15min after the procedure)
- Net Promotor Score (NPS) by patient(15min after the procedure)
- Total procedural time(intraoperative)
- Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)(Intraoperative)
- Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)(Intraoperative)