Clinical trial NCT03599479: Virtual Reality Experiences on Acute Pain and Distress
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Acute Pain
Anxiety
Keywords: Virtual reality
Acute pain
Anxiety
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 11-point scale pain score
timeFrame: 15min after the procedure
Secondary outcomes:
measure: Hamilton Anxiety rating score (HAM-A)
timeFrame: 15min after the procedure
measure: Net Promotor Score (NPS) by patient
timeFrame: 15min after the procedure
measure: Net Promotor Score (NPS) by physician
timeFrame: 15min after the procedure
measure: Total amount of local anesthetics used to skin infiltration
timeFrame: intraoperative
measure: Total procedural time
timeFrame: intraoperative
measure: Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)
timeFrame: Intraoperative
measure: Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)
timeFrame: Intraoperative
measure: Vital sign of the patient: electrocardiogram(ECG)
timeFrame: Intraoperative
measure: Vital sign of the patient: Heart rate (beat per minute)
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, MD, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1097/00007632-200005010-00017.
citation: 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.
citation: 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.
citation: 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.