Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Pain Clinical Trial

Official title:

Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914937
• Other study ID #: 1903-09
• Status: Completed
• Start date: April 22, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: February 2021
• Source: The Guthrie Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

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.
• Music
Music of the patient's choice will be played

Locations

Country	Name	City	State
United States	Robert Packer Hospital	Sayre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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