Perioperative PainNCT03744845
The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
A study testing Virtual Reality Distraction in people with Perioperative Pain and Perioperative Anxiety, run by University of California, San Francisco at 1 site in United States.
Trial summary
We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Pain, Perioperative Anxiety
- What is being tested?
- Virtual Reality Distraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 15 May 2024
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or older and less or equal to 75 years old.
- ASA physical status I-II.
- English speaking.
- Undergoing elective surgery with local anesthetic with sedation.
- Surgical time less than 2 hours.
Who cannot join
- ASA physical status III or above.
- Allergy to fentanyl, midazolam or propofol.
- History of seizure, migraines.
- Chronic Pain Syndrome.
- Use of high dose opioids or long acting opioids.
- Severe anxiety, on daily anxiolytics.
Show all 9Show fewer
- Psychiatric comorbidities that preclude the use of VR.
- Physical disabilities that preclude the use of VR technology in a comfortable manner.
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopedic Institute
San Francisco, California, 94158
About this study
We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.
Read the detailed description
Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.
- Conditions
- Perioperative Pain, Perioperative Anxiety
- Being tested
- Virtual Reality Distraction
- Keywords
- Pain, Anxiety, Intraoperative Care
- 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 Reality DistractionOther
This RCT will utilize an Oculus Go VR headset that delivers VR images and sound. Users will wear the VR headset. A research coordinator will familiarize patients with hardware before use. The VR will be used preoperatively and intraoperatively to distracts patients, and aid with the treatment of pain and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Usual anesthetic care. |
| Virtual Reality Intervention Group | Experimental | Virtual Reality Distraction Receives: Other: Virtual Reality Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Op Numeric Rating Scale for Pain
Self-reported pain intensity pre- and post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
Measured: 1 minute during pre-op period
Pre-Op Numeric Rating Scale for Anxiety
Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Measured: 1 minute during pre-op period
Post-Op Numeric Rating Scale for Pain
Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
Measured: 1 minute during PACU stay
Post-Op Numeric Rating Scale for Anxiety
Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Measured: 1 minute during PACU stay
Preoperative Medication Dosage
The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.
Measured: up to 2 hours during pre-op period
Intraoperative Medication Dosage
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.
Measured: up to 2 hours during surgery
Postoperative Medication Dosage
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.
Measured: approximately 1 hour during PACU stay
Secondary outcomes (4)
Blood Pressure
Systolic and diastolic blood pressure (mmHg)
Measured: up to 2 hours during surgery
Heart Rate
Beats per minute (bpm)
Measured: up to 2 hours during surgery
Satisfaction with Anesthesia Survey
An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.
Measured: 5 minutes during PACU stay
Virtual Reality (VR) Survey
An instrument designed by study staff to collect information on patients' experience wearing the VR device. The 16-question survey utilizes free-responses, yes/no, and ranked responses.
Measured: 5 minutes during PACU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start10 Dec 2018
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Perioperative PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakura Kinjo, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744845
- Sponsor's protocol ID
- 17-22021
- Status last verified
- Aug 2026
- First submitted
- 24 May 2018
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
PubMed 28475502Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
PubMed 18325675Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
PubMed 19955069Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
PubMed 16640481Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
PubMed 22864564Soelberg CD, Brown RE Jr, Du Vivier D, Meyer JE, Ramachandran BK. The US Opioid Crisis: Current Federal and State Legal Issues. Anesth Analg. 2017 Nov;125(5):1675-1681. doi: 10.1213/ANE.0000000000002403.
PubMed 29049113West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31.
PubMed 25678441Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
PubMed 27400458Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
PubMed 28598921Pandya PG, Kim TE, Howard SK, Stary E, Leng JC, Hunter OO, Mariano ER. Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Korean J Anesthesiol. 2017 Aug;70(4):439-445. doi: 10.4097/kjae.2017.70.4.439. Epub 2017 Mar 15.
PubMed 28794840
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings
- ClinicalTrials.gov ID
- NCT03744845
- Acronym / sponsor ID
- 17-22021
- Conditions
- Perioperative Pain, Perioperative Anxiety
- Keywords
- Pain, Anxiety, Intraoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 16 Nov 2018 (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.
We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.
Detailed description
Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Usual anesthetic care. |
| Virtual Reality Intervention Group | Experimental | Other: Virtual Reality DistractionVirtual Reality Distraction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or older and less or equal to 75 years old.
- ASA physical status I-II.
- English speaking.
- Undergoing elective surgery with local anesthetic with sedation.
- Surgical time less than 2 hours.
Key exclusion criteria (9 listed)
- ASA physical status III or above.
- Allergy to fentanyl, midazolam or propofol.
- History of seizure, migraines.
- Chronic Pain Syndrome.
- Use of high dose opioids or long acting opioids.
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 Reality DistractionThis RCT will utilize an Oculus Go VR headset that delivers VR images and sound. Users will wear the VR headset. A research coordinator will familiarize patients with hardware before use. The VR will be used preoperatively and intraoperatively to distracts patients, and aid with the treatment of pain and anxiety. | Other | Virtual Reality Intervention Group |
Primary outcome
Pre-Op Numeric Rating Scale for Pain
Time frame: 1 minute during pre-op period
Self-reported pain intensity pre- and post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
Pre-Op Numeric Rating Scale for Anxiety
Time frame: 1 minute during pre-op period
Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Post-Op Numeric Rating Scale for Pain
Time frame: 1 minute during PACU stay
Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).
Post-Op Numeric Rating Scale for Anxiety
Time frame: 1 minute during PACU stay
Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).
Preoperative Medication Dosage
Time frame: up to 2 hours during pre-op period
The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.
Intraoperative Medication Dosage
Time frame: up to 2 hours during surgery
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.
Postoperative Medication Dosage
Time frame: approximately 1 hour during PACU stay
The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.
4 secondary outcomes
Blood Pressure
Time frame: up to 2 hours during surgery
Heart Rate
Time frame: up to 2 hours during surgery
Satisfaction with Anesthesia Survey
Time frame: 5 minutes during PACU stay
Virtual Reality (VR) Survey
Time frame: 5 minutes during PACU stay
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 10 Aug 2026.
- Background: PubMed 28475502Maples-Keller JL, Bunnell BE, Kim SJ, Rothbaum BO. The Use of Virtual Reality Technology in the Treatment of Anxiety and Other Psychiatric Disorders. Harv Rev Psychiatry. 2017 May/Jun;25(3):103-113. doi: 10.1097/HRP.0000000000000138.
- Background: PubMed 18325675Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
- Background: PubMed 19955069Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.
- Background: PubMed 16640481Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.
- Background: PubMed 22864564Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
- Background: PubMed 29049113Soelberg CD, Brown RE Jr, Du Vivier D, Meyer JE, Ramachandran BK. The US Opioid Crisis: Current Federal and State Legal Issues. Anesth Analg. 2017 Nov;125(5):1675-1681. doi: 10.1213/ANE.0000000000002403.
- Background: PubMed 25678441West NA, Severtson SG, Green JL, Dart RC. Trends in abuse and misuse of prescription opioids among older adults. Drug Alcohol Depend. 2015 Apr 1;149:117-21. doi: 10.1016/j.drugalcdep.2015.01.027. Epub 2015 Jan 31.
- Background: PubMed 27400458Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and Risk Factors for Chronic Opioid Use Among Opioid-Naive Patients in the Postoperative Period. JAMA Intern Med. 2016 Sep 1;176(9):1286-93. doi: 10.1001/jamainternmed.2016.3298.
- Background: PubMed 28598921Chan PY, Scharf S. Virtual Reality as an Adjunctive Nonpharmacological Sedative During Orthopedic Surgery Under Regional Anesthesia: A Pilot and Feasibility Study. Anesth Analg. 2017 Oct;125(4):1200-1202. doi: 10.1213/ANE.0000000000002169.
- Background: PubMed 28794840Pandya PG, Kim TE, Howard SK, Stary E, Leng JC, Hunter OO, Mariano ER. Virtual reality distraction decreases routine intravenous sedation and procedure-related pain during preoperative adductor canal catheter insertion: a retrospective study. Korean J Anesthesiol. 2017 Aug;70(4):439-445. doi: 10.4097/kjae.2017.70.4.439. Epub 2017 Mar 15.
- 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.
Sakura Kinjo, M.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction in people with Perioperative Pain and Perioperative Anxiety, run by University of California, San Francisco 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 5 inclusion and 9 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 10 Aug 2026. 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?
Pre-Op Numeric Rating Scale for Pain (time frame: 1 minute during pre-op period). The study lists 7 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 NCT03744845, which also lists 10 linked publications.
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 10 Aug 2026.