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

Primary Purpose

Scar, Acute Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HTC Vive
Without HTC Vive
Sponsored by
Kai-Yang Lv
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scar focused on measuring virtual reality, fractional laser, scars, acute pain, anxiety score

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or non-pregnant women between the ages of 18 and 60;
  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:

  1. Poor physical condition before operative, it is estimated that can't tolerate local anesthesia surgery;
  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.

Sites / Locations

  • HTC ViveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Possess HTC Vive before the operation

Without HTC Vive before the operation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain scores
Intraoperative pain score, postoperation pain score.(0: no pain; 10: worst imaginable pain)

Secondary Outcome Measures

Anxiety score
Intraoperative anxiety score, preoperative anxiety score.
Heart rate
Intraoperative highest heart rate, preoperative heart rate and postoperative heart rate.
Respiratory rate
Preoperative respiratory rate, intraoperative maximum respiratory rate and postoperative respiratory rate.
Blood pressure
Preoperative basal blood pressure and postoperative blood pressure.
Surgical satisfaction
Surgical satisfaction of treatment with 10 maximum square spot areas and complete all surgery.(0: unsatisfied; 5: very Satisfied)
Operating time
Operating time of 10 maximum square spot areas.

Full Information

First Posted
November 17, 2017
Last Updated
November 26, 2017
Sponsor
Kai-Yang Lv
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1. Study Identification

Unique Protocol Identification Number
NCT03352752
Brief Title
Virtual Reality Technology to Alleviate the Acute Pain of Scar Treatment With Fractional Laser 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
August 11, 2020 (Anticipated)
Study Completion Date
December 21, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kai-Yang Lv

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar, Acute Pain
Keywords
virtual reality, fractional laser, scars, acute pain, anxiety score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Open Label
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Possess HTC Vive before the operation
Arm Type
Experimental
Arm Description
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.
Arm Title
Without HTC Vive before the operation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HTC Vive
Intervention Description
Wearing VR helmet before operation
Intervention Type
Other
Intervention Name(s)
Without HTC Vive
Intervention Description
Wearing a blindfold before operation
Primary Outcome Measure Information:
Title
Pain scores
Description
Intraoperative pain score, postoperation pain score.(0: no pain; 10: worst imaginable pain)
Time Frame
From before the operation to the end the surgery; about one hour
Secondary Outcome Measure Information:
Title
Anxiety score
Description
Intraoperative anxiety score, preoperative anxiety score.
Time Frame
From beginning of the operation to the end of the operation; about one hour
Title
Heart rate
Description
Intraoperative highest heart rate, preoperative heart rate and postoperative heart rate.
Time Frame
From into the group to the end of the surgery;about six hours
Title
Respiratory rate
Description
Preoperative respiratory rate, intraoperative maximum respiratory rate and postoperative respiratory rate.
Time Frame
From into the group to the end of the surgery;about six hours
Title
Blood pressure
Description
Preoperative basal blood pressure and postoperative blood pressure.
Time Frame
From the into the group to the end of the surgery;about six hours
Title
Surgical satisfaction
Description
Surgical satisfaction of treatment with 10 maximum square spot areas and complete all surgery.(0: unsatisfied; 5: very Satisfied)
Time Frame
From beginning of the operation to the end of the operation;about one hour
Title
Operating time
Description
Operating time of 10 maximum square spot areas.
Time Frame
From beginning of the operation to the end of the operation with 10 maximum square spot areas;about ten seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lv Kaiyang, doctor
Phone
+86 13816983691
Email
lvkaiyang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lou Xiaozhen, bachelor
Phone
+86 13916781312
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lv Kaiyang, doctor
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
HTC Vive
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Huazhen, master
Phone
+86 17601246182
Email
lesyin@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25068543
Citation
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.
Results Reference
result
PubMed Identifier
25068544
Citation
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.
Results Reference
result
PubMed Identifier
15216537
Citation
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.
Results Reference
result
PubMed Identifier
24336931
Citation
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.
Results Reference
result
PubMed Identifier
21264690
Citation
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.
Results Reference
result
PubMed Identifier
23327918
Citation
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.
Results Reference
result
PubMed Identifier
22558746
Citation
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.
Results Reference
result

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

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