Virtual Reality Experiences on Acute Pain and Distress

NCT03599479 | Completed DMC

• 1 other identifier: 1802-028-920
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Virtual Reality; Acute Pain; Anxiety

Keywords

Virtual reality; Acute pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 11-point scale pain score

  11-point scale pain score was assessed by the patient during the fluoroscopic-guided intervention, 0-10. 0 means no pain, 10 means the most severe pain one can imagine

  15min after the procedure

Secondary Outcomes (9)

• Hamilton Anxiety rating score (HAM-A)

  15min after the procedure

• Net Promotor Score (NPS) by patient

  15min after the procedure

• Net Promotor Score (NPS) by physician

  15min after the procedure

• Total amount of local anesthetics used to skin infiltration

  intraoperative

• Total procedural time

  intraoperative

Study Arms (2)

Virtual reality group

EXPERIMENTAL

* 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.

Device: Virtual reality group

Conventional group

NO INTERVENTION

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

Interventions

Virtual reality group 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.

Also known as: Experimental

Virtual reality group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 10788861 BACKGROUND

• 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.

  PMID: 21779307 BACKGROUND

• 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.

  PMID: 18427228 RESULT

• 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.

  PMID: 19230769 RESULT

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jee Youn Moon, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 26, 2018
• Study Start: December 27, 2018
• Primary Completion: August 28, 2020
• Study Completion: January 2, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)