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RecruitingNCT04490603Updated May 29, 2024

The Effect of Virtual Reality Experience on Infusion-related Pain

An interventional study of Virtual reality experience in Virtual Reality, sponsored by Seoul National University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by Seoul National University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Virtual Reality
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralVirtual 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.

05

What researchers measure

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

06

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Korea, Republic of
    • Jee Youn Moon, M.D. · Contact · jymoon0901@gmail.com · 82-10-5299-2036
    • Jee Youn Moon, PhD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04490603
Lead sponsor
Seoul National University
Responsible party
Jeeyoun Moon (Associate professor, Seoul National University) — Principal investigator
First posted
Jul 29, 2020
Start date
Aug 19, 2020
Primary completion
Dec 28, 2024 (estimated)
Completion
Dec 28, 2024 (estimated)
Last update
May 29, 2024

Study contacts

Jee Youn Moon, PhD
Contact
jymoon0901@gmail.com
82-02-2072-2952
Jee Youn Moon, PhD
study director · Associate Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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