Virtual Reality Experiences on Acute Pain and Distress

NCT ID: NCT03599479

Last Updated: 2022-11-04

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

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2021-01-02

Brief Summary

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The aim of this study is to evaluate the efficacy of virtual reality experiences on acute pain and distress caused by fluoroscopic pain intervention in chronic pain patient.

Detailed Description

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The investigators perform lots of interventions for patients. But unfortunately, patients cannot help being exposed to the acute pain and fear during the interventions. "Virtual Reality(VR)" is a state-of-art advanced technology, which is now being extended to various medical fields such as pain management, dental treatment, body rehabilitation and cancer pain. There is no study that have conjugated the virtual reality experience for patients' acute pain and anxiety which occurs during the pain interventions. So the investigators like to evaluate the effects of virtual reality experience on acute pain and anxiety precipitated by the pain interventions.

Conditions

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Virtual Reality Acute Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual reality group

* After experiencing the VR machine in the transfer bed for 5 minutes, the subject moves to the operating room.
* After the subject moves to the surgical bed, he/she takes the appropriate position for the fluoroscopic pain intervention, and wears the virtual reality device (headset, headphone, smartphone).
* After the subject starts the VR program, the practitioner starts the fluoroscopic pain intervention.
* Lidocaine skin infiltration and description of the practitioner during the intervention are performed with the intervention when necessary.

Group Type EXPERIMENTAL

Virtual reality group

Intervention Type DEVICE

Virtual reality group The study intervention is to provide acute pain management for the subject undergoing fluoroscopic pain intervention by using the virtual reality program provided by the collaborator through virtual reality device (headset, headphone, and smartphone) that are commercialized on the market.

Conventional group

The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality group

Virtual reality group The study intervention is to provide acute pain management for the subject undergoing fluoroscopic pain intervention by using the virtual reality program provided by the collaborator through virtual reality device (headset, headphone, and smartphone) that are commercialized on the market.

Intervention Type DEVICE

Other Intervention Names

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Experimental

Eligibility Criteria

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Inclusion Criteria

If all of the following conditions are met :

* Patient who has chronic pain lasting more than 3 months and whose pain doctor determined that he or she needs following fluoroscopic pain intervention : Lumbar sympathetic ganglion block (LSGB), Fluoroscopic-guided pulsed radiofrequency ablation (pRF), Fluoroscopic-guided radiofrequency thermocoagulation (hRF)
* Adults who are at least 20 years of age
* Patients whose American Society of Anesthesiologists(ASA) physical status is classified as 1 or 2.
* A person who voluntarily agrees to participate in this clinical trial and has agreed in informed consent.

Exclusion Criteria

If the subject falls under any of the following conditions :

* Patients who cannot have virtual reality experience due to hearing or visual impairment
* If the patient has difficulty communicating due to lack of cognitive ability
* Patients that examiners deemed unsuitable for this trial
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, MD, PhD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Linton SJ. A review of psychological risk factors in back and neck pain. Spine (Phila Pa 1976). 2000 May 1;25(9):1148-56. doi: 10.1097/00007632-200005010-00017.

Reference Type BACKGROUND
PMID: 10788861 (View on PubMed)

Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.

Reference Type BACKGROUND
PMID: 21779307 (View on PubMed)

Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain. 2008 May;24(4):299-304. doi: 10.1097/AJP.0b013e318164d2cc.

Reference Type RESULT
PMID: 18427228 (View on PubMed)

Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

Reference Type RESULT
PMID: 19230769 (View on PubMed)

Other Identifiers

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1802-028-920

Identifier Type: -

Identifier Source: org_study_id

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