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Virtual Reality Experiences on Acute Pain and Distress

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ClinicalTrials.gov Identifier: NCT03599479
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jeeyoun Moon, 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.

Condition or disease Intervention/treatment Phase
Virtual Reality Acute Pain Anxiety Device: Virtual reality group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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.



Primary Outcome Measures :
  1. 11-point scale pain score [ Time Frame: 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 :
  1. Hamilton Anxiety rating score (HAM-A) [ Time Frame: 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.

  2. Net Promotor Score (NPS) by patient [ Time Frame: 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

  3. Net Promotor Score (NPS) by physician [ Time Frame: 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

  4. Total amount of local anesthetics used to skin infiltration [ Time Frame: intraoperative ]
    Total amount of local anesthetics used to skin infiltration (ml)

  5. Total procedural time [ Time Frame: intraoperative ]
    Total procedural time (minute)

  6. Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%) [ Time Frame: Intraoperative ]
    Percutaneous oxygen saturation(SPO2,%)

  7. Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg) [ Time Frame: Intraoperative ]
    noninvasive blood pressure(NIBP, mm Hg)

  8. Vital sign of the patient: electrocardiogram(ECG) [ Time Frame: Intraoperative ]
    Arrhythmia

  9. Vital sign of the patient: Heart rate (beat per minute) [ Time Frame: Intraoperative ]
    Heart rate (beat per minute)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599479


Contacts
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Contact: Jee Youn Moon, MD, PhD 821052992036 jymoon0901@gmail.com
Contact: Eunkyoung Kim, MD 821090995937 eunkyoung2lovely@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University
Investigators
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Study Director: Jee Youn Moon, MD, PhD Seoul National University Hospital
Publications of Results:
Other Publications:
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Responsible Party: Jeeyoun Moon, Associate professor, Seoul National University
ClinicalTrials.gov Identifier: NCT03599479    
Other Study ID Numbers: 1802-028-920
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeeyoun Moon, Seoul National University:
Virtual reality
Acute pain
Anxiety
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms