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The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group: Virtual Reality | Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent |
| |
| Control Group: Music | Patients will listen to music in addition to standard lidocaine/novocaine numbing agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for minor elective plastic surgery procedure
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Packer Hospital | Sayre | Pennsylvania | 18840 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
| Label | URL |
|---|---|
| Link to publication doi: 10.4236/ss.2023.146050. | View source |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music | Other | Music of the patient's choice will be played |
|
| 1 hour |
| 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 |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |