The Effect of Virtual Reality Experience on Infusion-related Pain
1 other identifier
interventional
72
1 country
1
Brief Summary
This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2024
CompletedMay 29, 2024
May 1, 2024
4.4 years
July 26, 2020
May 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Patient satisfaction with virtual reality experience
Right after the produre for 50 minutes ended.
Intervention-related wellness index-1 (IWI-1)
Right after the produre for 50 minutes ended.
Intervention-related wellness index-2 (IWI-2)
Right after the produre for 50 minutes ended.
Study Arms (2)
Conventional group
NO INTERVENTIONDrug 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
EXPERIMENTALDrug 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
Study Officials
- STUDY DIRECTOR
Jee Youn Moon, PhD
Associate Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 26, 2020
First Posted
July 29, 2020
Study Start
August 19, 2020
Primary Completion
December 28, 2024
Study Completion
December 28, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share