Virtual RealityNCT04490603
The Effect of Virtual Reality Experience on Infusion-related Pain
A study testing Virtual reality experience in people with Virtual Reality, run by Seoul National University at 1 site in South Korea.
Trial summary
This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual reality experience
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Aug 2020to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jee Youn Moon, M.D., 82-10-5299-2036, jymoon0901@gmail.com
Jee Youn Moon, PhD
About this study
Official title: The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.
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.
- Conditions
- Virtual Reality
- Being tested
- Virtual reality experience
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality experienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | No intervention | 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. |
| VR group | Experimental | 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. Receives: Behavioral: Virtual reality experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related pain
Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)
Measured: Right after the produre for 50 minutes ended.
Secondary outcomes (3)
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
Measured: 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).
Measured: 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)
Measured: Right after the produre for 50 minutes ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start19 Aug 2020
- Primary completion28 Dec 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized open-label clinical trial
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, PhD, Study director, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490603
- Sponsor's protocol ID
- 2005-086-1123
- Status last verified
- May 2024
- First submitted
- 26 Jul 2020
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT04490603
- Acronym / sponsor ID
- 2005-086-1123
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized open-label clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional group | No intervention | –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. |
| VR group | Experimental | Behavioral: Virtual reality experienceDrug 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality experiencePatients 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. | Behavioural | VR group |
Primary outcome
Procedure-related pain
Time frame: Right after the produre for 50 minutes ended.
Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)
3 secondary outcomes
Patient satisfaction with virtual reality experience
Time frame: Right after the produre for 50 minutes ended.
Intervention-related wellness index-1 (IWI-1)
Time frame: Right after the produre for 50 minutes ended.
Intervention-related wellness index-2 (IWI-2)
Time frame: Right after the produre for 50 minutes ended.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Youn Moon, PhD study director
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality experience in people with Virtual Reality, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Youn Moon, PhD (82-02-2072-2952, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related pain (time frame: Right after the produre for 50 minutes ended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.