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This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional group | No Intervention | 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. | |
| VR group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality experience | Behavioral | 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. |
| 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. |
| 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) |
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Inclusion Criteria: If all of the following conditions are met
Exclusion Criteria: If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jee Youn Moon, PhD | Contact | 82-02-2072-2952 | jymoon0901@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jee Youn Moon, PhD | Associate Professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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Prospective randomized open-label clinical trial
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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. |