PainNCT03914937
Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
An observational study of Pain and Anxiety, run by The Guthrie Clinic at 1 site in United States.
Trial summary
The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- Virtual reality and Music
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for minor elective plastic surgery procedure
Who may be able to join
- Patients scheduled for minor elective plastic surgery procedure
- Patients without cognitive, visual or hearing impairments
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures
Read the 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.
- Being tested
- Virtual reality, Music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.
MusicOther
Music of the patient's choice will be played
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Virtual Reality | Patients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent Receives: Other: Virtual reality | |
| Control Group: Music | Patients will listen to music in addition to standard lidocaine/novocaine numbing agent Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start22 Apr 2019
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim W Sadik, MD, Principal investigator, The Guthrie ClinicCrystal D Sadik, MD, Principal investigator, The Guthrie ClinicNicholas Evertson, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914937
- Sponsor's protocol ID
- 1903-09
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2019
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction
- ClinicalTrials.gov ID
- NCT03914937
- Acronym / sponsor ID
- 1903-09
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Virtual Reality | – | Other: Virtual realityPatients will wear a virtual reality device in addition to standard lidocaine/novocaine numbing agent |
| Control Group: Music | – | Other: MusicPatients will listen to music in addition to standard lidocaine/novocaine numbing agent |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for minor elective plastic surgery procedure
Key inclusion criteria (2 listed)
- Patients scheduled for minor elective plastic surgery procedure
- Patients without cognitive, visual or hearing impairments
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityA virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach. | Other | Intervention Group: Virtual Reality |
| MusicMusic of the patient's choice will be played | Other | Control Group: Music |
Primary outcome
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.
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.
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.
2 secondary outcomes
Anxiety
Time frame: 1 hour
Patient Satisfaction
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publicationSadik, 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.
- Link to publication doi: 10.4236/ss.2023.146050.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim W Sadik, MD principal investigator
The Guthrie Clinic
Crystal D Sadik, MD principal investigator
The Guthrie Clinic
Nicholas Evertson, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by The Guthrie Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Pain (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.