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Completed

NCT Number: NCT03599479

Virtual Reality Experiences on Acute Pain and Distress

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.

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Key information

Conditions

Virtual Reality Acute Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality group

Device

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 names: Experimental

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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