Virtual Reality
Conditions
Brief summary
This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.
Detailed description
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.
Interventions
BEHAVIORALVirtual reality experience
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.
Sponsors
Seoul National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective randomized open-label clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related pain | Right after the produre for 50 minutes ended. | Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with virtual reality experience | Right after the produre for 50 minutes ended. | 5-point Likert-like verbal rating scale: 1, extremely satisfied; 2, satisfied; 3, undecided; 4, dissatisfied; 5, extremely dissatisfied |
| Intervention-related wellness index-1 (IWI-1) | Right after the produre for 50 minutes ended. | 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). |
| Intervention-related wellness index-2 (IWI-2) | Right after the produre for 50 minutes ended. | 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) |
Countries
South Korea
Contacts
Primary ContactJee Youn Moon, PhD
Outcome results
None listed