The Effect of Virtual Reality Experience on Infusion-related Pain

Virtual Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490603
• Other study ID #: 2005-086-1123
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: December 28, 2024

Study information

• Verified date: May 2024
• Source: Seoul National University
• Contact: Jee Youn Moon, PhD
• Phone: 82-02-2072-2952
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 28, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.