Virtual Reality Technology to Alleviate the Acute Pain of Scar Treatment With Fractional Laser Under Local Anesthesia

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of virtual reality technology alleviates the acute pain of scar treatment with fractional laser under local anesthesia

Detailed Description
-----------------
Fractional laser surgery under local anesthesia will accompany by the pain and anxiety. It's a bad experience for the patients. The effect of Virtual Reality (virtual reality, VR) to alleviate pain and anxiety of fractional laser treatment of scar is still not studied. Virtual reality technology is an important direction of simulation technology. Including the computer graphics technology, human-computer interface technology, multimedia technology, sensor technology, network technology and other collection technology. Usually generated by a real-time 3D animation of the computer system, a location tracker data. The handle and the head mounted display technology is commonly used in a variety of clinical invasive procedures, such as debridement and burn patients physical therapy, dental pain, injection pain, chronic itching. Previous study shows that VR as a distraction therapy, compared to the traditional methods ,for example watching video and listening to music, has stronger individual initiative and human-computer interaction, it shows a stronger analgesic effect. HTC Vive is a VR headset, jointly developed by HTC company and Valve company. This equipment could improve the virtual reality experience and bring obvious analgesic effect. There are reasons to believe that HTC Vive could bring the best immersion experience and could be obviously decrease pain and anxiety of scar treatment with fractional laser under local anesthesia. This study was conducted at department of burn, Changhai hospital, and all operations completed by experienced surgeons (researcher). This study is a prospective randomized controlled study. A group of patients wear a blindfold and the other group treated with VR equipment (HTC Vive) after localized anesthesia with standard lidocaine cream. Finally, the differences of pain score,anxiety score, physiological indicators and satisfaction between two groups are compared. This study could provide a safe and non-drug intervention measure for patients receive fractional laser treatment under local anesthesia.

Official Title
-----------------
The Effect of Virtual Reality Technology to Alleviate the Acute Pain of Scar Treatment With Fractional Laser Under Local Anesthesia: a Single Center, Randomized, Controlled, Clinical Study

Conditions
-----------------
Scar, Acute Pain

Intervention / Treatment
-----------------
* Device: HTC Vive
* Other: Without HTC Vive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant women between the ages of 18 and 60； The scar site to be treated is located outside the head and face, scar area ≥ 0.5% total body surface area (TBSA)； All patients should be sign information. Exclusion Criteria: Poor physical condition before operative, it is estimated that can't tolerate local anesthesia surgery； Associated with malignant tumors, all kinds of heart disease history, hypertensive patients; Patients with mental illness, alcohol-dependent patients, post-traumatic stress disorder, drug abuse history, and drug addicts; patients with pregnancy; lidocaine cream allergies; Patients can't tolerate VR experience or participate in other clinical trials； Unable or unwilling to comply with research programs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It's a randomized controlled study, there were 218 cases, the ratio of the control group to the experimental group was one to one，109 cases per group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Possess HTC Vive before the operation<br>The experimental group was wearing VR helmet before operation, and the immersion experience was selected from the video content library pre-selected. After 3 minutes of the VR experience, the surgeon started the fractional laser operation (Notify the patient). The operating area is continuous 10 maximum square spot areas.The parameters for the DEEP FX mode:35mj, 5% density, 300Hz. | Device: HTC Vive<br>* Wearing VR helmet before operation<br>|
| Experimental: Without HTC Vive before the operation<br>The control group was wearing a blindfold before operation. The operating area is continuous 10 maximum square spot areas. The parameters for the DEEP FX mode:35mj, 5% density, 300Hz. | Other: Without HTC Vive<br>* Wearing a blindfold before operation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Intraoperative pain score, postoperation pain score.(0: no pain; 10: worst imaginable pain) | From before the operation to the end the surgery; about one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety score | Intraoperative anxiety score, preoperative anxiety score. | From beginning of the operation to the end of the operation; about one hour | 
| Heart rate | Intraoperative highest heart rate, preoperative heart rate and postoperative heart rate. | From into the group to the end of the surgery;about six hours | 
| Respiratory rate | Preoperative respiratory rate, intraoperative maximum respiratory rate and postoperative respiratory rate. | From into the group to the end of the surgery;about six hours | 
| Blood pressure | Preoperative basal blood pressure and postoperative blood pressure. | From the into the group to the end of the surgery;about six hours | 
| Surgical satisfaction | Surgical satisfaction of treatment with 10 maximum square spot areas and complete all surgery.(0: unsatisfied; 5: very Satisfied) | From beginning of the operation to the end of the operation;about one hour | 
| Operating time | Operating time of 10 maximum square spot areas. | From beginning of the operation to the end of the operation with 10 maximum square spot areas;about ten seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, fractional laser, scars, acute pain, anxiety score