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OpenTrials
Completed

NCT Number: NCT03914937

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

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Music

Other

Music of the patient's choice will be played

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Guthrie Clinic

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2019
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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