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Virtual Reality Experiences on Acute Pain and Distress

Primary Purpose

Virtual Reality, Acute Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality group
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Virtual Reality focused on measuring Virtual reality, Acute pain, Anxiety

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality group

Conventional group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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
Total amount of local anesthetics used to skin infiltration
Total amount of local anesthetics used to skin infiltration (ml)
Total procedural time
Total procedural time (minute)
Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)
Percutaneous oxygen saturation(SPO2,%)
Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)
noninvasive blood pressure(NIBP, mm Hg)
Vital sign of the patient: electrocardiogram(ECG)
Arrhythmia
Vital sign of the patient: Heart rate (beat per minute)
Heart rate (beat per minute)

Full Information

First Posted
June 24, 2018
Last Updated
November 3, 2022
Sponsor
Seoul National University
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1. Study Identification

Unique Protocol Identification Number
NCT03599479
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 27, 2018 (Actual)
Primary Completion Date
August 28, 2020 (Actual)
Study Completion Date
January 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Acute Pain, Anxiety
Keywords
Virtual reality, Acute pain, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases.
Intervention Type
Device
Intervention Name(s)
Virtual reality group
Other Intervention Name(s)
Experimental
Intervention Description
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.
Primary Outcome Measure Information:
Title
11-point scale pain score
Description
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
Time Frame
15min after the procedure
Secondary Outcome Measure Information:
Title
Hamilton Anxiety rating score (HAM-A)
Description
total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
15min after the procedure
Title
Net Promotor Score (NPS) by patient
Description
On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague
Time Frame
15min after the procedure
Title
Net Promotor Score (NPS) by physician
Description
On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague
Time Frame
15min after the procedure
Title
Total amount of local anesthetics used to skin infiltration
Description
Total amount of local anesthetics used to skin infiltration (ml)
Time Frame
intraoperative
Title
Total procedural time
Description
Total procedural time (minute)
Time Frame
intraoperative
Title
Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)
Description
Percutaneous oxygen saturation(SPO2,%)
Time Frame
Intraoperative
Title
Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)
Description
noninvasive blood pressure(NIBP, mm Hg)
Time Frame
Intraoperative
Title
Vital sign of the patient: electrocardiogram(ECG)
Description
Arrhythmia
Time Frame
Intraoperative
Title
Vital sign of the patient: Heart rate (beat per minute)
Description
Heart rate (beat per minute)
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10788861
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.
Results Reference
background
PubMed Identifier
21779307
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.
Results Reference
background
PubMed Identifier
18427228
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.
Results Reference
result
PubMed Identifier
19230769
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.
Results Reference
result

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Virtual Reality Experiences on Acute Pain and Distress

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