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This study evaluates the effect of virtual reality technology alleviates the acute pain of scar treatment with fractional laser under local anesthesia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Possess HTC Vive before the operation | Experimental | 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. |
|
| Without HTC Vive before the operation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTC Vive | Device | Wearing VR helmet before operation |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lv Kaiyang, doctor | Contact | +86 13816983691 | lvkaiyang@hotmail.com | |
| Lou Xiaozhen, bachelor | Contact | +86 13916781312 |
| Name | Affiliation | Role |
|---|---|---|
| Lv Kaiyang, doctor | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HTC Vive | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25068543 | Result | Gold MH, Berman B, Clementoni MT, Gauglitz GG, Nahai F, Murcia C. Updated international clinical recommendations on scar management: part 1--evaluating the evidence. Dermatol Surg. 2014 Aug;40(8):817-24. doi: 10.1111/dsu.0000000000000049. | |
| 25068544 | Result | Gold MH, McGuire M, Mustoe TA, Pusic A, Sachdev M, Waibel J, Murcia C; International Advisory Panel on Scar Management. Updated international clinical recommendations on scar management: part 2--algorithms for scar prevention and treatment. Dermatol Surg. 2014 Aug;40(8):825-31. doi: 10.1111/dsu.0000000000000050. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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It's a randomized controlled study, there were 218 cases, the ratio of the control group to the experimental group was one to oneļ¼109 cases per group.
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Open Label
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| Without HTC Vive |
| Other |
Wearing a blindfold before operation |
|
| 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 |
| 15216537 | Result | Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048. |
| 24336931 | Result | Anderson RR, Donelan MB, Hivnor C, Greeson E, Ross EV, Shumaker PR, Uebelhoer NS, Waibel JS. Laser treatment of traumatic scars with an emphasis on ablative fractional laser resurfacing: consensus report. JAMA Dermatol. 2014 Feb;150(2):187-93. doi: 10.1001/jamadermatol.2013.7761. |
| 21264690 | Result | Hoffman HG, Chambers GT, Meyer WJ 3rd, Arceneaux LL, Russell WJ, Seibel EJ, Richards TL, Sharar SR, Patterson DR. Virtual reality as an adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures. Ann Behav Med. 2011 Apr;41(2):183-91. doi: 10.1007/s12160-010-9248-7. |
| 23327918 | Result | Wang HB, Fang Y, Yu WR. [Advancement in the research of fractional carbon dioxide laser in treating burn scars]. Zhonghua Shao Shang Za Zhi. 2012 Dec;28(6):465-7. Chinese. |
| 22558746 | Result | Gallant J, Smith R, Wynn J, Vazquez E. 2012 HIV Drug Guide. Posit Aware. 2012 Mar-Apr;24(2):15-7, 22, 24-57 passim. No abstract available. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |