## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 1802-028-920
#### Organization
**Class:** OTHER
**Full Name:** Seoul National University
### Status Module
#### Completion Date
**Date:** 2021-01-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-04

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-08-28

**Type:** ACTUAL

#### Start Date
**Date:** 2018-12-27

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2018-07-26
**Type:** ACTUAL
**Study First Submit Date:** 2018-06-24
**Study First Submit QC Date:** 2018-07-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Seoul National University

#### Responsible Party

**Investigator Affiliation:** Seoul National University

**Investigator Full Name:** Jeeyoun Moon

**Investigator Title:** Associate professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Virtual Reality

- Acute Pain

- Anxiety

**Keywords:**

- Virtual reality

- Acute pain

- Anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 44

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Virtual reality group

**Label:** Virtual reality group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Conventional group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Virtual reality group

**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.

**Name:** Virtual reality group

**Other Names:**

- Experimental

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**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

**Measure:** 11-point scale pain score

**Time Frame:** 15min after the procedure

#### Secondary Outcomes

**Description:** total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

**Measure:** Hamilton Anxiety rating score (HAM-A)

**Time Frame:** 15min after the procedure

**Description:** On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague

**Measure:** Net Promotor Score (NPS) by patient

**Time Frame:** 15min after the procedure

**Description:** On a scale of 0 to 10, score 10 means most likely to recommend VR to a friend or a colleague

**Measure:** Net Promotor Score (NPS) by physician

**Time Frame:** 15min after the procedure

**Description:** Total amount of local anesthetics used to skin infiltration (ml)

**Measure:** Total amount of local anesthetics used to skin infiltration

**Time Frame:** intraoperative

**Description:** Total procedural time (minute)

**Measure:** Total procedural time

**Time Frame:** intraoperative

**Description:** Percutaneous oxygen saturation(SPO2,%)

**Measure:** Vital sign of the patient: Percutaneous oxygen saturation(SPO2,%)

**Time Frame:** Intraoperative

**Description:** noninvasive blood pressure(NIBP, mm Hg)

**Measure:** Vital sign of the patient: noninvasive blood pressure(NIBP, mm Hg)

**Time Frame:** Intraoperative

**Description:** Arrhythmia

**Measure:** Vital sign of the patient: electrocardiogram(ECG)

**Time Frame:** Intraoperative

**Description:** Heart rate (beat per minute)

**Measure:** Vital sign of the patient: Heart rate (beat per minute)

**Time Frame:** Intraoperative

### Eligibility Module

**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

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Seoul National University Hospital

**Name:** Jee Youn Moon, MD, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 10788861

**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.

**PMID:** 21779307

**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.

**PMID:** 18427228

**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.

**PMID:** 19230769

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M29442

- Name: Chronic Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29525

- Name: Acute Pain

- Relevance: HIGH

- As Found: Acute Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059787

- Term: Acute Pain

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
