The Effect of Virtual Reality Experience on Infusion-related Pain

NCT ID: NCT04490603

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2024-12-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized open-label clinical trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Virtual reality experience

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University

OTHER

Sponsor Role lead

Responsible Party

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Jeeyoun Moon

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jee Youn Moon, PhD

Role: STUDY_DIRECTOR

Associate Professor

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jee Youn Moon, PhD

Role: CONTACT

82-02-2072-2952

Facility Contacts

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Jee Youn Moon, M.D.

Role: primary

82-10-5299-2036

Other Identifiers

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2005-086-1123

Identifier Type: -

Identifier Source: org_study_id

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