The Effect of Virtual Reality Experience on Infusion-related Pain

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

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

Study Overview

• Status: Recruiting
• Conditions: Virtual Reality
• Intervention / Treatment: Behavioral: Virtual reality experience

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jee Youn Moon, PhD; Phone Number: 82-02-2072-2952; Email: jymoon0901@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jee Youn Moon, M.D.; Phone Number: 82-10-5299-2036; Email: jymoon0901@gmail.com
    • Principal Investigator: Jee Youn Moon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional group; 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; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Study Director: Jee Youn Moon, PhD, Associate Professor

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Estimated): December 28, 2023
• Study Completion (Estimated): December 28, 2023

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: July 26, 2020
• First Posted (Actual): July 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2005-086-1123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No