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Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914937
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

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

Condition or disease Intervention/treatment
Pain Anxiety 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. Anxiety [ Time Frame: 1 hour ]
    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.

  2. Patient Satisfaction [ Time Frame: 1 hour ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for minor elective plastic surgery procedure
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914937


Contacts
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Contact: Karim W Sadik, MD 570-887-2884 Karim.Sadik@guthrie.org
Contact: Crystal D Sadik, MD 570-887-2884 Crystal.Sadik@guthrie.org

Locations
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United States, Pennsylvania
Robert Packer Hospital Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Karim Sadik, MD    570-887-2884    Karim.Sadik@guthrie.org   
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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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
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT03914937    
Other Study ID Numbers: 1903-09
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No