Virtual Reality Experiences on Acute Pain and Distress

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599479
• Other study ID #: 1802-028-920
• Status: Completed
• Phase: N/A
• Start date: December 27, 2018
• Est. completion date: January 2, 2021

Study information

• Verified date: November 2022
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2, 2021
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Virtual Reality

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

Li A, Montaño Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. — View Citation

Linton SJ. A review of psychological risk factors in back and neck pain. Spine (Phila Pa 1976). 2000 May 1;25(9):1148-56. Review. — View Citation

Nilsson S, Finnström B, Kokinsky E, Enskär 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. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Total amount of local anesthetics used to skin infiltration	Total amount of local anesthetics used to skin infiltration (ml)	intraoperative
Secondary	Total procedural time	Total procedural time (minute)	intraoperative
Secondary	Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)	Percutaneous oxygen saturation(SPO2,%)	Intraoperative
Secondary	Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)	noninvasive blood pressure(NIBP, mm Hg)	Intraoperative
Secondary	Vital sign of the patient: electrocardiogram(ECG)	Arrhythmia	Intraoperative
Secondary	Vital sign of the patient: Heart rate (beat per minute)	Heart rate (beat per minute)	Intraoperative