Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Study Overview
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Brief Summary
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The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

Detailed Description
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Patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. Patients will still get the standard lidocaine/novocaine numbing agent. Patients will be asked questions about their anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of anxiety and pain.

Official Title
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Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Other: Virtual reality
* Other: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for minor elective plastic surgery procedure Patients without cognitive, visual or hearing impairments Exclusion Criteria: Patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) Lesions that involve portions of the head or face that will prohibit the use of VR goggles Severe vertigo Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (MRSA, VRE) were excluded. Patients who are pregnant Hearing or visually impaired Patients <18 years old

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention Group: Virtual Reality<br>Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent | Other: Virtual reality<br>* A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.<br>|
| Control Group: Music<br>Patients will listen to music in addition to standard lidocaine/novocaine numbing agent | Other: Music<br>* Music of the patient's choice will be played<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Pain | Subjective pain measured using the 11-point Numeric Rating Scale (NRS), which is widely employed and is a validated measure of pain (17) at the half way point and 1 minute after the procedure.The scale name is Pain Numeric Rating Scale (NRS) it is a validated scale for graphically measuring pain. The scale range is 0-10 (11 point scale). 0 is no pain. 10 is intolerable pain. The values on this scale will be averaged for each cohort. | 1 hour | 
| Blood pressure | Systolic and diastolic blood pressures (mmHg) at the half way point of the procedure as well as 1 minute after completion of the procedure. Blood pressure will be measured as a surrogate measure for objective pain. Blood pressures will be averaged for each cohort. The data will be collected by Dynamap automated Blood pressure monitor. | 1 hour | 
| Heart rate | Heart rate at the half way point of the procedure as well as 1 minute after completion of the procedure will be measured in beats per minute using pulse oximetry. Heart rate will be measured as a surrogate measure for objective pain. Heart rates will be averaged for each cohort. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety using an 11-point Numeric Rating Scale (NRS) at the half way point and 1 minute after completion of the procedure.The scale name for subjective anxiety measurement will be the Numeric Rating Scale (NRS) it is a validated scale for graphically measuring anxiety. The scale range is 0-10 (11 point scale). 0 is no pain. 10 is intolerable pain. The values on this scale will be averaged for each cohort. | 1 hour | 
| Patient Satisfaction | Patient satisfaction determined by the Global Rating Scale measured as 1-5 with 1 being unsatisfied and 5 being extremely satisfied. The Global Rating Scale (GRS) for patient satisfaction is a validated scale. These values will be averaged in each cohort. | 1 hour |