Virtual Reality Experiences on Acute Pain and Distress

Not Applicable

Completed

• Conditions: Acute Pain; Anxiety; Virtual Reality
• Interventions: Device: Virtual reality group

• Registration Number: NCT03599479
• Lead Sponsor: Seoul National University

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.

Study Timeline

• Study First Submitted: 2018-06-24
• Study First Submitted QC: 2018-07-23
• Study First Posted: 2018-07-26
• Study Start: 2018-12-27
• Primary Completion: 2020-08-28
• Study Completion: 2021-01-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality group	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.

Primary Outcome Measures

Name	Time	Method
11-point scale pain score	15min after the procedure	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of