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Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03914937
Enrollment
40
Registered
2019-04-16
Start date
2019-04-22
Completion date
2020-08-01
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

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.

Interventions

OTHERVirtual 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.

OTHERMusic

Music of the patient's choice will be played

Sponsors

The Guthrie Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective Pain1 hourSubjective 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.
Blood pressure1 hourSystolic 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.
Heart rate1 hourHeart 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

MeasureTime frameDescription
Anxiety1 hourAnxiety 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.
Patient Satisfaction1 hourPatient 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026