The Effect of Virtual Reality Experience on Infusion-related Pain

Not Applicable

Recruiting

• Conditions: Virtual Reality
• Interventions: Behavioral: Virtual reality experience

• Registration Number: NCT04490603
• Lead Sponsor: Seoul National University

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.

Study Timeline

• Study First Submitted: 2020-07-26
• Study First Submitted QC: 2020-07-26
• Study First Posted: 2020-07-29
• Study Start: 2020-08-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-27
• Last Update Posted: 2024-05-29
• Primary Completion: 2024-12-28
• Study Completion: 2024-12-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR group	Virtual reality experience	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of