Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

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

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: Virtual reality; Other: Music

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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients scheduled for minor elective plastic surgery procedure

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Guthrie Clinic
• Investigators: Principal Investigator: Karim W Sadik, MD, The Guthrie Clinic; Principal Investigator: Crystal D Sadik, MD, The Guthrie Clinic; Principal Investigator: Nicholas Evertson, MD, The Guthrie Clinic

Publications and helpful links

General Publications

• Sadik, K. , Miller, M. , Evertsen, N. , Sadik, C. and Bonatti, H. (2023) Virtual Reality in Surgery: Double Blind, Randomized Clinical Trial of Pain Control and Augmented Satisfaction. Surgical Science, 14, 456-467. doi: 10.4236/ss.2023.146050.

Helpful Links

• Link to publication doi: 10.4236/ss.2023.146050.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1903-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No