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Clinical Trials/NCT03914937
NCT03914937
Completed
Not Applicable

Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

The Guthrie Clinic1 site in 1 country40 target enrollmentApril 22, 2019
ConditionsPainAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
The Guthrie Clinic
Enrollment
40
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 22, 2019
End Date
August 1, 2020
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Blood pressure

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Patient Satisfaction(1 hour)
  • Anxiety(1 hour)

Study Sites (1)

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