Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
- Conditions
- PainAnxiety
- Interventions
- Other: Virtual realityOther: Music
- Registration Number
- NCT03914937
- Lead Sponsor
- The Guthrie Clinic
- Brief Summary
The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Patients scheduled for minor elective plastic surgery procedure
- Patients without cognitive, visual or hearing impairments
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention Group: Virtual Reality Virtual reality Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent Control Group: Music Music Patients will listen to music in addition to standard lidocaine/novocaine numbing agent
- Primary Outcome Measures
Name Time Method Blood pressure 1 hour 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.
Subjective Pain 1 hour 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.
Heart rate 1 hour 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.
- Secondary Outcome Measures
Name Time Method Patient Satisfaction 1 hour 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.
Anxiety 1 hour 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.
Trial Locations
- Locations (1)
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States