Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

NCT03914937 | Completed

• 1 other identifier: 1903-09
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Anxiety

  1 hour

• Patient Satisfaction

  1 hour

Study Arms (2)

Intervention Group: Virtual Reality

Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent

Other: Virtual reality

Control Group: Music

Patients will listen to music in addition to standard lidocaine/novocaine numbing agent

Other: Music

Interventions

Virtual reality OTHER

A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.

Intervention Group: Virtual Reality

Music OTHER

Music of the patient's choice will be played

Control Group: Music

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for minor elective plastic surgery procedure

You may qualify if:

• Patients scheduled for minor elective plastic surgery procedure
• Patients without cognitive, visual or hearing impairments

You may not qualify if:

• 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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Related Publications (1)

• 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.

  RESULT

Related Links

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

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karim W Sadik, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

• Crystal D Sadik, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

• Nicholas Evertson, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 16, 2019
• Study Start: April 22, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)