Virtual Reality Experiences on Acute Pain and Distress

Seoul National University44 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Virtual Reality Acute Pain Anxiety

Interventions

Virtual reality groupDEVICE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 15min after the procedure

Secondary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 15min after the procedure

Total amount of local anesthetics used to skin infiltration

Total amount of local anesthetics used to skin infiltration (ml)

Time frame: intraoperative

Total procedural time

Total procedural time (minute)

Time frame: intraoperative

Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)

Percutaneous oxygen saturation(SPO2,%)

Time frame: Intraoperative

Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)

Data from ClinicalTrials.gov

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