Virtual Reality Technology to Alleviate the Acute Pain of Scar Treatment With Fractional Laser Under Local Anesthesia
NCT ID: NCT03352752
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
218 participants
INTERVENTIONAL
2017-08-02
2020-12-21
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Possess HTC Vive before the operation
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.
HTC Vive
Wearing VR helmet before operation
Without HTC Vive before the operation
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.
Without HTC Vive
Wearing a blindfold before operation
Interventions
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HTC Vive
Wearing VR helmet before operation
Without HTC Vive
Wearing a blindfold before operation
Eligibility Criteria
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Inclusion Criteria
2. The scar site to be treated is located outside the head and face, scar area ≥ 0.5% total body surface area (TBSA)；
3. All patients should be sign information.
Exclusion Criteria
2. Associated with malignant tumors, all kinds of heart disease history, hypertensive patients;
3. Patients with mental illness, alcohol-dependent patients, post-traumatic stress disorder, drug abuse history, and drug addicts; patients with pregnancy; lidocaine cream allergies;
4. Patients can't tolerate VR experience or participate in other clinical trials；
5. Unable or unwilling to comply with research programs.
18 Years
60 Years
ALL
No
Sponsors
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Kai-Yang Lv
OTHER
Responsible Party
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Kai-Yang Lv
Associate Professor
Principal Investigators
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Lv Kaiyang, doctor
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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HTC Vive
Shanghai, , China
Countries
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Central Contacts
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Lou Xiaozhen, bachelor
Role: CONTACT
Phone: +86 13916781312
Facility Contacts
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Liu Huazhen, master
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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kylv
Identifier Type: -
Identifier Source: org_study_id