Anesthesia, IntravenousOR-VRNCT03614325
Virtual Reality in the Operating Room
A study testing Virtual Reality Immersive Relaxation in people with Anesthesia, Intravenous and Pain, Postoperative, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia
- What is being tested?
- Virtual Reality Immersive Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC
Who cannot join
- Age < 18
- Open wounds or active infection of the face or eye area
- History of seizures or other symptom linked to an epileptic condition
- Patients who plan to wear hearing aids during the procedure
- Patients with a pacemaker or other implanted medical device
- Droplet or airborne precautions (as determined by BIDMC infection control policy)
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- Non-English speaking
- Patients who require deep sedation
- Patients who are deemed ineligible to approach by the surgeon
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.
Read the detailed description
The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.
- Conditions
- Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia, Satisfaction, Relaxation Therapy
- Being tested
- Virtual Reality Immersive Relaxation
- Medical subject headings
- Pain, Postoperative, Delayed Emergence from Anesthesia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Immersive RelaxationOther
The software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Anesthesia Care | No intervention | Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery. |
| Virtual Reality Immersive Relaxation | Experimental | Patients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness.
Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. Receives: Other: Virtual Reality Immersive Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Propofol Dose
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
Measured: 60 minutes
Secondary outcomes (8)
Other Intraoperative Anesthetics or Analgesics Administered
Total dose of additional anesthetics (other than propofol) or analgesics administered intraoperatively will be measured for the duration of the procedure.
Measured: 60 minutes
Total Intraoperative Propofol Administered
Total propofol dose (mg bolus, mg infusion, and mg total) administered intraoperatively will be measured for the duration of the procedure.
Measured: 60 minutes
Length of PACU Stay
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes
Measured: Duration of the patient's stay in the post anesthesia care unit, 100 minutes
Pain Assessed by Eleven Point Numerical Rating Scale
Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Measured: Duration of stay in the post anesthesia care unit, 100 minutes
Overall Patient Satisfaction
Patient satisfaction will be assessed using a survey which asks about ease of use, programming preferences and overall study satisfaction. The satisfaction score will be reported on a scale from 0 (worst outcome; very unsatisfied) to 100 (best outcome; very satisfied).
Measured: PACU discharge
Patient Survey: Agreement With the Following Statements (0-100)
Patients are asked their level of agreement with statements about how well their pain was controlled, whether they felt anxious, whether they felt relaxed, whether they could remember their time in surgery, and whether they would be interested in using VR for another surgery. The total score will be reported on a scale from 0 (worst outcome, no agreement) to 100 (best outcome, total agreement).
Measured: PACU discharge
Hand Disability (QuickDASH)
As assessed by the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score; a patient reported outcome scale regarding hand disability. Scores range from 0 (no disability) to 100 (most severe disability).
Measured: One month postoperatively
Difference Between Preoperative and Postoperative QuickDASH Scores
As assessed by the QuickDASH score, a patient reported outcome scale regarding hand disability. Higher scores indicate a patient's worse disability. This is to measure the difference in patient's disability before vs after their surgery.
Measured: One month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start4 Dec 2018
- Primary completion7 Nov 2019
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, IntravenousStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- VRHealth Group Ltd
- Responsible party
- Principal investigator, Brian O'Gara, Beth Israel Deaconess Medical Center
- Investigators
- Brian O'Gara, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614325
- Sponsor's protocol ID
- 2018P000398
- Acronym
- OR-VR
- Status last verified
- Oct 2023
- First submitted
- 9 Jul 2018
- Last updated
- 8 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.
PubMed 31882015
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in the Operating Room: Using Immersive Relaxation as an Adjunct to Anesthesia
- ClinicalTrials.gov ID
- NCT03614325
- Acronym / sponsor ID
- OR-VR / 2018P000398
- Conditions
- Anesthesia, Intravenous, Pain, Postoperative, Delayed Recovery From Anesthesia, Satisfaction, Relaxation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- VRHealth Group Ltd
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 8 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, controlled trial designed to investigate whether the use of virtual reality immersive relaxation during hand/arm operations can allow for a relaxing operating room experience for patients while potentially reducing anesthesia requirements.
Detailed description
The proposed study is a randomized, controlled trial to evaluate the effectiveness of VR as an adjunct to standard anesthetic practice for upper extremity surgery. Patients will be randomized to undergo immersion relaxation via the use of VR during their procedure or control. In both groups patients will undergo regional anesthesia preoperatively according to standard practice. Patients will then be assessed postoperatively to assess the intraoperative propofol dose between groups, as well as secondary outcomes including patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Anesthesia Care | No intervention | –Patients in the usual care arm will undergo the current standard of care for hand/wrist surgery and postoperative recovery. They will be asked to refrain from using a virtual reality headset during their surgery. |
| Virtual Reality Immersive Relaxation | Experimental | Other: Virtual Reality Immersive RelaxationPatients in the experimental group will wear a headset and be immersed in a virtual reality environment during their surgery. There are various short videos and environments such as sitting on a beach that are designed to promote relaxation and calmness. Throughout their surgery patients will be monitored according to current anesthesia standards. The relaxation programming will run for the duration of the operative procedure. At the end of the procedure the headset will be removed and standard postoperative care will commence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing upper extremity (hand, wrist, arm, and/or elbow) surgery at BIDMC under MAC
Key exclusion criteria (9 listed)
- Age < 18
- Open wounds or active infection of the face or eye area
- History of seizures or other symptom linked to an epileptic condition
- Patients who plan to wear hearing aids during the procedure
- Patients with a pacemaker or other implanted medical device
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 Immersive RelaxationThe software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation. | Other | Virtual Reality Immersive Relaxation |
Primary outcome
Intraoperative Propofol Dose
Time frame: 60 minutes
Total propofol dose (mg/kg/min) administered intraoperatively will be measured for the duration of the procedure.
8 secondary outcomes
Other Intraoperative Anesthetics or Analgesics Administered
Time frame: 60 minutes
Total Intraoperative Propofol Administered
Time frame: 60 minutes
Length of PACU Stay
Time frame: Duration of the patient's stay in the post anesthesia care unit, 100 minutes
Pain Assessed by Eleven Point Numerical Rating Scale
Time frame: Duration of stay in the post anesthesia care unit, 100 minutes
Overall Patient Satisfaction
Time frame: PACU discharge
Patient Survey: Agreement With the Following Statements (0-100)
Time frame: PACU discharge
Hand Disability (QuickDASH)
Time frame: One month postoperatively
Difference Between Preoperative and Postoperative QuickDASH Scores
Time frame: One month postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31882015Faruki A, Nguyen T, Proeschel S, Levy N, Yu J, Ip V, Mueller A, Banner-Goodspeed V, O'Gara B. Virtual reality as an adjunct to anesthesia in the operating room. Trials. 2019 Dec 27;20(1):782. doi: 10.1186/s13063-019-3922-2.
- 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.
Brian O'Gara, MD principal investigator
Beth Israel Deaconess Medical Center
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 Immersive Relaxation in people with Anesthesia, Intravenous and Pain, Postoperative, run by Beth Israel Deaconess Medical Center 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 1 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 8 Apr 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?
Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative Propofol Dose (time frame: 60 minutes). 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 NCT03614325, 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 8 Apr 2024.