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ScarNCT03352752

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

A study testing HTC Vive and Without HTC Vive in people with Scar and Acute Pain, run by Kai-Yang Lv at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the effect of virtual reality technology alleviates the acute pain of scar treatment with fractional laser under local anesthesia Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Scar, Acute Pain
What is being tested?
HTC Vive and Without HTC Vive
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteChina
Study dates
2 Aug 2017to 21 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lv Kaiyang, doctor contact

+86 13816983691

lvkaiyang@hotmail.com

Lou Xiaozhen, bachelor contact

+86 13916781312

China1 site, 1 recruiting

  • HTC Vive

    Shanghai

    Liu Huazhen, master, +86 17601246182, lesyin@163.com

    Recruiting

Other trials in China

About this study

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

This study evaluates the effect of virtual reality technology alleviates the acute pain of scar treatment with fractional laser under local anesthesia

Read the 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.

Conditions
Scar, Acute Pain
Being tested
HTC Vive, Without HTC Vive
Keywords
virtual reality, fractional laser, scars, acute pain, anxiety score
Medical subject headings
Cicatrix, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HTC ViveDevice

    Wearing VR helmet before operation

  • Without HTC ViveOther

    Wearing a blindfold before operation

Study groups in NCT03352752
Study groupRoleWhat they receive
Possess HTC Vive before the operationExperimentalThe 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.
Receives: Device: HTC Vive
Without HTC Vive before the operationExperimentalThe 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.
Receives: Other: Without HTC Vive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain scores

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

    Measured: From before the operation to the end the surgery; about one hour

Secondary outcomes (6)

  1. Anxiety score

    Intraoperative anxiety score, preoperative anxiety score.

    Measured: From beginning of the operation to the end of the operation; about one hour

  2. Heart rate

    Intraoperative highest heart rate, preoperative heart rate and postoperative heart rate.

    Measured: From into the group to the end of the surgery;about six hours

  3. Respiratory rate

    Preoperative respiratory rate, intraoperative maximum respiratory rate and postoperative respiratory rate.

    Measured: From into the group to the end of the surgery;about six hours

  4. Blood pressure

    Preoperative basal blood pressure and postoperative blood pressure.

    Measured: From the into the group to the end of the surgery;about six hours

  5. Surgical satisfaction

    Surgical satisfaction of treatment with 10 maximum square spot areas and complete all surgery.(0: unsatisfied; 5: very Satisfied)

    Measured: From beginning of the operation to the end of the operation;about one hour

  6. Operating time

    Operating time of 10 maximum square spot areas.

    Measured: From beginning of the operation to the end of the operation with 10 maximum square spot areas;about ten seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2017
  2. Study start2 Aug 2017
  3. Primary completion11 Aug 2020 (estimated)
  4. Study completion21 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03352752
Sponsor's protocol ID
kylv
Status last verified
Nov 2017
First submitted
17 Nov 2017
Last updated
28 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25068543

  • 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.

    PubMed 25068544

  • 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.

    PubMed 15216537

  • 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.

    PubMed 24336931

  • 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.

    PubMed 21264690

  • 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.

    PubMed 23327918

  • 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.

    PubMed 22558746

Questions about this trial

What is this clinical trial studying?

A study testing HTC Vive and Without HTC Vive in people with Scar and Acute Pain, run by Kai-Yang Lv at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lv Kaiyang, doctor (+86 13816983691, lvkaiyang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain scores (time frame: From before the operation to the end the surgery; about one hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03352752, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.

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