The Effect of Virtual Reality Experience on Infusion-related Pain

Study Overview
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Brief Summary
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This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.

Detailed Description
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Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. However, there is no active countermeasure against pain during these procedures. This prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.

Official Title
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The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.

Conditions
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Virtual Reality

Intervention / Treatment
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* Behavioral: Virtual reality experience


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: If all of the following conditions are met A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease. Adults over 20 Those who decided to participate out of his/her own free will and signed in written consent Exclusion Criteria: If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial. In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc) Hearing and vision impairments Affective disorder History of epilepsy or seizure If communication is not possible due to impaired cognitive ability Those who have been deemed inappropriate by the researchers

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
Interventional Model Description: Prospective randomized open-label clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional group<br>Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided in the same way as the conventional method of injecting drugs in Seoul National University Hospital Pain Center. | |
| Experimental: VR group<br>Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided with virtual reality experience. Conditions are the same in both arms except for virtual reality experience. | Behavioral: Virtual reality experience<br>* Patients are to experice virtual reality with virtual reality experience equipment (headsets, headphones, smartphones) and virtual reality experience programs. The equipments and programs are commercialized products on the market rather than medical products.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related pain | Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible) | Right after the produre for 50 minutes ended. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with virtual reality experience | 5-point Likert-like verbal rating scale: 1, extremely satisfied; 2, satisfied; 3, undecided; 4, dissatisfied; 5, extremely dissatisfied | Right after the produre for 50 minutes ended. | 
| Intervention-related wellness index-1 (IWI-1) | Drug injection-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score) are calculated through principal component analysis as a new variable, IW index-1 (IWI-1). | Right after the produre for 50 minutes ended. | 
| Intervention-related wellness index-2 (IWI-2) | Calculated as IWI-2 by summing the procedure-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score) | Right after the produre for 50 minutes ended. |