The Effect of Virtual Reality Experience on Infusion-related Pain

Seoul National University72 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Virtual Reality

Interventions

Virtual reality experienceBEHAVIORAL

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

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Procedure-related pain

Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)

Time frame: Right after the produre for 50 minutes ended.

Secondary Outcomes

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

Time frame: 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).

Time frame: 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)

Time frame: Right after the produre for 50 minutes ended.

Central Contacts

Jee Youn Moon, PhD

CONTACT

82-02-2072-2952 jymoon0901@gmail.com

Data from ClinicalTrials.gov

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