Virtual Reality Experiences on Acute Pain and Distress

The Efficacy of Virtual Reality Experiences on Acute Pain and Distress Caused by Fluoroscopic Pain Intervention in Chronic Pain Patients - A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Acute Pain; Virtual Reality
• Intervention / Treatment: Device: Virtual reality group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Experimental
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety rating score (HAM-A)	total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	15min after the procedure
Net Promotor Score (NPS) by patient	On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague	15min after the procedure
Net Promotor Score (NPS) by physician	On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague	15min after the procedure
Total amount of local anesthetics used to skin infiltration	Total amount of local anesthetics used to skin infiltration (ml)	intraoperative
Total procedural time	Total procedural time (minute)	intraoperative
Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)	Percutaneous oxygen saturation(SPO2,%)	Intraoperative
Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)	noninvasive blood pressure(NIBP, mm Hg)	Intraoperative
Vital sign of the patient: electrocardiogram(ECG)	Arrhythmia	Intraoperative
Vital sign of the patient: Heart rate (beat per minute)	Heart rate (beat per minute)	Intraoperative

Collaborators and Investigators

• Sponsor: Seoul National University
• Investigators: Study Director: Jee Youn Moon, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Actual): August 28, 2020
• Study Completion (Actual): January 2, 2021

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Anxiety; Virtual reality; Acute pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 1802-028-920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No