Virtual RealityNCT03599479
Virtual Reality Experiences on Acute Pain and Distress
A study testing Virtual reality group in people with Virtual Reality and Acute Pain, run by Seoul National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Virtual Reality, Acute Pain, Anxiety
- What is being tested?
- Virtual reality group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Dec 2018to 2 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Virtual Reality, Acute Pain, Anxiety
- Being tested
- Virtual reality group
- Keywords
- Virtual reality, Acute pain, Anxiety
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality groupDevice
Also called Experimental
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | * 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. Receives: Device: Virtual reality group |
| Conventional group | No intervention | The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15min after the procedure
Secondary outcomes (9)
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.
Measured: 15min after the procedure
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
Measured: 15min after the procedure
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
Measured: 15min after the procedure
Total amount of local anesthetics used to skin infiltration
Total amount of local anesthetics used to skin infiltration (ml)
Measured: intraoperative
Total procedural time
Total procedural time (minute)
Measured: intraoperative
Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)
Percutaneous oxygen saturation(SPO2,%)
Measured: Intraoperative
Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)
noninvasive blood pressure(NIBP, mm Hg)
Measured: Intraoperative
Vital sign of the patient: electrocardiogram(ECG)
Arrhythmia
Measured: Intraoperative
Vital sign of the patient: Heart rate (beat per minute)
Heart rate (beat per minute)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start27 Dec 2018
- Primary completion28 Aug 2020
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, MD, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599479
- Sponsor's protocol ID
- 1802-028-920
- Status last verified
- Nov 2022
- First submitted
- 24 Jun 2018
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10788861Li 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.
PubMed 21779307Hoffman 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.
PubMed 18427228Nilsson 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.
PubMed 19230769
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03599479
- Acronym / sponsor ID
- 1802-028-920
- Conditions
- Virtual Reality, Acute Pain, Anxiety
- Keywords
- Virtual reality, Acute pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Device: 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. |
| Conventional group | No intervention | –The fluoroscopic pain intervention is performed using only local anesthetics and description of the practitioner during the intervention as in the conventional cases. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality groupAlso: ExperimentalVirtual 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. | Device | Virtual reality group |
Primary outcome
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
9 secondary outcomes
Hamilton Anxiety rating score (HAM-A)
Time frame: 15min after the procedure
Net Promotor Score (NPS) by patient
Time frame: 15min after the procedure
Net Promotor Score (NPS) by physician
Time frame: 15min after the procedure
Total amount of local anesthetics used to skin infiltration
Time frame: intraoperative
Total procedural time
Time frame: intraoperative
Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)
Time frame: Intraoperative
Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)
Time frame: Intraoperative
Vital sign of the patient: electrocardiogram(ECG)
Time frame: Intraoperative
Vital sign of the patient: Heart rate (beat per minute)
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 10788861Linton 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.
- Background: PubMed 21779307Li 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 publication: PubMed 18427228Hoffman 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 publication: PubMed 19230769Nilsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Youn Moon, MD, PhD study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality group in people with Virtual Reality and Acute Pain, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point scale pain score (time frame: 15min after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599479, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.