Acute Pain, Scar
Conditions
Keywords
virtual reality, fractional laser, scars, acute pain, anxiety score
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.
Interventions
DEVICEHTC Vive
Wearing VR helmet before operation
OTHERWithout HTC Vive
Wearing a blindfold before operation
Sponsors
Kai-Yang Lv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | From before the operation to the end the surgery; about one hour | Intraoperative pain score, postoperation pain score.(0: no pain; 10: worst imaginable pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | From the into the group to the end of the surgery;about six hours | Preoperative basal blood pressure and postoperative blood pressure. |
| Surgical satisfaction | From beginning of the operation to the end of the operation;about one hour | Surgical satisfaction of treatment with 10 maximum square spot areas and complete all surgery.(0: unsatisfied; 5: very Satisfied) |
| Respiratory rate | From into the group to the end of the surgery;about six hours | Preoperative respiratory rate, intraoperative maximum respiratory rate and postoperative respiratory rate. |
| Anxiety score | From beginning of the operation to the end of the operation; about one hour | Intraoperative anxiety score, preoperative anxiety score. |
| Heart rate | From into the group to the end of the surgery;about six hours | Intraoperative highest heart rate, preoperative heart rate and postoperative heart rate. |
| Operating time | From beginning of the operation to the end of the operation with 10 maximum square spot areas;about ten seconds | Operating time of 10 maximum square spot areas. |
Countries
China
Contacts
Primary ContactLv Kaiyang, doctor
Backup ContactLou Xiaozhen, bachelor
Outcome results
None listed