Virtual RealityV-RAPSNCT06522711
Virtual Reality for Anxiolysis and Pharmacological Sparing
A study testing Virtual reality headset in people with Virtual Reality and Propofol, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Virtual Reality, Propofol
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2024to 1 Sep 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully consented female patients above the age of 18 years;
- Undergoing elective, awake, breast surgery performed under paravertebral block.
Who cannot join
- Hearing or visual impairment;
- History of epilepsy, seizure or severe dizziness;
- Severe mental impairment;
- Recent eye or facial surgery or wounds;
- Inability to use the VR hand controller.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
Montreal East, Quebec, H1T2M4
Pascal Laferriere-Langlois, MD, MSc, +1-819-432-5847, pascal.laferriere-langlois@umontreal.ca
Pascal Laferriere-Langlois, MD, MSc
About this study
Official title: Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial
The goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is:
Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia?
Read more
Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device.
Participants will be randomly assigned to either a virtual reality (intervention) group or a control group.
- The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice.
- Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.
Read the detailed description
Virtual reality (VR) has carved out a growing place for itself in our leisure activities, video games and even in medicine. Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care (e.g. wound care, dental care, venous access). While the population most frequently investigated is pediatric, the benefits can be extended to other populations. The operating room is uncommon due to the type of procedure and the older patient profile. Yet, with the democratization of regional and neuraxial anesthesia, VR could improve the patient experience in the operating room.
The main objective of this study is to explore the impact of VR on intravenous (I.V.) sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block. The hypothesis is that VR will serve as an effective distraction in the operative context, reducing the need for pharmacology. In parallel, multiple secondary objectives will also be explored, such as the evaluation of the tolerance to the VR headset, the impact of the chosen type of scenario on the primary outcome, the incidence of adverse effects, the variation of the Nociception Level Index (NOL index) in awake patients as well as overall patient satisfaction.
This single center, open-label, randomized controlled trial will be conducted in a Canadian academic hospital. 100 patients above the age of 18 years undergoing breast surgery (mastectomy, reduction, augmentation, reconstruction, etc.) under regional anesthesia, specifically paravertebral block, will be included in this study. Patients will be randomized either to the intervention group or the control group. The intervention group will have a VR helmet and the control group a standard treatment. Both will have access to patient-controlled sedation (PCS), self-administering their own sedation under clinical observation. Patients in the VR group will be able to choose, before the procedure begins, between 3 different VR environments and will also be allowed to switch between these environments during the surgery. The primary outcome of this study will be the time-weighted dose of propofol (sedative) self-administered during the procedure. Secondary outcomes will include patient satisfaction, premature removal of VR helmet, presence of nausea, desaturation, hypotension and post-anesthesia monitoring time.
- Conditions
- Virtual Reality, Propofol
- Being tested
- Virtual reality headset, Standard of care
- Keywords
- Virtual reality, Anxiety, Patient-controlled sedation, Pain, Propofol, Breast surgery
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
A brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient expresses a desire to stop using VR during the surgery, we will first offer them an alternate scenario. If they reiterate their willingness to stop, with or without having experienced the new scenario, the headset will be removed for the remainder of the surgery.
Standard of careOther
Standard of care in anesthesia with patient-controlled sedation.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Patients assigned to use a virtual reality headset during their surgery. Receives: Device: Virtual reality headset |
| Control | Active comparator | Standard of care group. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol self-administration
Time-adjusted and weight-adjusted average self-administration of propofol in mcg/kg/min in female patients undergoing breast surgery under paravertebral block.
Measured: Between 1 hour and 3 hours
Secondary outcomes (14)
Preoperative anxiety
Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale.
Measured: Up to 1 hour
Remifentanil administration
Time-adjusted and weight-adjusted average administration of remifentanil in mcg/kg/min.
Measured: Between 1 hour and 3 hours
Ketamine administration
Weight-adjusted administration of ketamine in mg/kg.
Measured: Between 1 hour and 3 hours
Adverse events
The incidence of adverse events such as cybersickness, nausea, bradycardia, desaturation and hypotension.
Measured: Between 1 hour and 3 hours
Scenario switches
Percentage of patients that switched scenarios.
Measured: Between 1 hour and 3 hours
Virtual reality usage
The total time, in minutes, as well as the relative time compared to the duration of the surgery, expressed as a percentage, during which the VR headset was worn.
Measured: Between 1 hour and 3 hours
Virtual reality usage per first scenario
Total duration in minutes spent by the patient on the VR scenario chosen, and the order in which VR scenarios were presented.
Measured: Between 1 hour and 3 hours
Virtual reality headset removal
Percentage of patients that removed the headset before the end of the surgery.
Measured: Between 1 hour and 3 hours
Post-Anesthesia Care Unit stay
The total time in minutes spent in the PACU.
Measured: Between 30 minutes and 2 hours
Enthusiasm at the idea of using virtual reality
Initial enthusiasm at the idea of using a VR headset during surgery assessed on a 10 point Likert scale.
Measured: Up to 1 hour
Ease of use
Ease of use of the virtual reality technology assessed on a 10 point Likert scale.
Measured: Between 30 minutes and 2 hours
Enjoyment of the first scenario chosen
Enjoyment of the first scenario chosen assessed on a 10 point Likert scale.
Measured: Between 30 minutes and 2 hours
Overall satisfaction
Overall satisfaction with the experience assessed on a 10 point Likert scale
Measured: Between 30 minutes and 2 hours
NOL index readings
NOL index readings over time per patient, assessed continuously.
Measured: Between 1 hour and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After the participants meet all the inclusion criteria and meet no exclusion criteria, patients will then be randomized by an unbiased algorithm in a 1 for 1 ratio (one control patient for each patient in the virtual reality group). However, the chosen scenario in the virtual reality group will be a result of each patient's personal preference; the patients will also be able to switch between scenarios at will.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Paperplane Therapeutics
- Responsible party
- Principal investigator, Pascal Laferrière-Langlois, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Pascal Laferriere-Langlois, MD, MSc, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522711
- Sponsor's protocol ID
- 2025-3802
- Acronym
- V-RAPS
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boutin J, Kamoonpuri J, Faieghi R, Chung J, de Ribaupierre S, Eagleson R. Smart haptic gloves for virtual reality surgery simulation: a pilot study on external ventricular drain training. Front Robot AI. 2024 Jan 10;10:1273631. doi: 10.3389/frobt.2023.1273631. eCollection 2023.
PubMed 38269073Boyce L, Jordan C, Egan T, Sivaprakasam R. Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. Pain. 2024 Apr 1;165(4):741-752. doi: 10.1097/j.pain.0000000000003086. Epub 2023 Oct 23.
PubMed 37870233Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
PubMed 31136330Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17.
PubMed 35976578Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.
PubMed 34908872Hitching R, Hoffman HG, Garcia-Palacios A, Adamson MM, Madrigal E, Alhalabi W, Alhudali A, Sampaio M, Peterson B, Fontenot MR, Mason KP. The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. J Clin Med. 2023 Jan 20;12(3):843. doi: 10.3390/jcm12030843.
PubMed 36769490Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.
PubMed 32092098Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.
PubMed 29750696Kuhn AW, Yu JK, Gerull KM, Silverman RM, Aleem AW. Virtual Reality and Surgical Simulation Training for Orthopaedic Surgery Residents: A Qualitative Assessment of Trainee Perspectives. JB JS Open Access. 2024 Mar 20;9(1):e23.00142. doi: 10.2106/JBJS.OA.23.00142. eCollection 2024 Jan-Mar.
PubMed 38511201Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.
PubMed 26884890Rudkin GE, Osborne GA, Curtis NJ. Intra-operative patient-controlled sedation. Anaesthesia. 1991 Feb;46(2):90-2. doi: 10.1111/j.1365-2044.1991.tb09345.x.
PubMed 1872456Ryu S, Kitagawa T, Goto K, Okamoto A, Marukuchi R, Hara K, Ito R, Nakabayashi Y. Intraoperative Holographic Guidance Using Virtual Reality and Mixed Reality Technology During Laparoscopic Colorectal Cancer Surgery. Anticancer Res. 2022 Oct;42(10):4849-4856. doi: 10.21873/anticanres.15990.
PubMed 36192000Wang Y, Guo L, Xiong X. Effects of Virtual Reality-Based Distraction of Pain, Fear, and Anxiety During Needle-Related Procedures in Children and Adolescents. Front Psychol. 2022 Apr 19;13:842847. doi: 10.3389/fpsyg.2022.842847. eCollection 2022.
PubMed 35519646Yamashita Y, Aijima R, Danjo A. Clinical effects of different virtual reality presentation content on anxiety and pain: a randomized controlled trial. Sci Rep. 2023 Nov 22;13(1):20487. doi: 10.1038/s41598-023-47764-8.
PubMed 37993645Yi WS, Rouhi AD, Duffy CC, Ghanem YK, Williams NN, Dumon KR. A Systematic Review of Immersive Virtual Reality for Nontechnical Skills Training in Surgery. J Surg Educ. 2024 Jan;81(1):25-36. doi: 10.1016/j.jsurg.2023.11.012. Epub 2023 Nov 30.
PubMed 38036388
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Strategy for Intra-operatory Anxiolysis and Pharmacological Sparing in Patients Undergoing Breast Surgeries : the V-RAPS Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06522711
- Acronym / sponsor ID
- V-RAPS / 2025-3802
- Conditions
- Virtual Reality, Propofol
- Keywords
- Virtual reality, Anxiety, Patient-controlled sedation, Pain, Propofol, Breast surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Paperplane Therapeutics
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Jul 2024 (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 goal of this clinical trial is to learn if virtual reality can reduce propofol requirements in adult, female patients undergoing elective breast surgery under regional anesthesia. The main question it aims to answer is:
Can virtual reality immersion reduce intra-operative propofol requirements in adult female patients undergoing elective breast surgery under regional anesthesia?
Researchers will compare time and weight-adjusted average propofol requirements in both the intervention group and the control group to see if there is a reduction in sedative usage in the group using the virtual reality device.
Participants will be randomly assigned to either a virtual reality (intervention) group or a control group.
- The patients in the virtual reality group will have a virtual reality headset on during the surgery with a preselected scenario of their choice.
- Both groups will have access to patient-controlled sedation under the supervision of an anesthesiologist and will be permitted to self-administer propofol boluses as needed.
Detailed description
Virtual reality (VR) has carved out a growing place for itself in our leisure activities, video games and even in medicine. Recent studies show that VR can reduce anxiety and pain in patients undergoing uncomfortable care (e.g. wound care, dental care, venous access). While the population most frequently investigated is pediatric, the benefits can be extended to other populations. The operating room is uncommon due to the type of procedure and the older patient profile. Yet, with the democratization of regional and neuraxial anesthesia, VR could improve the patient experience in the operating room.
The main objective of this study is to explore the impact of VR on intravenous (I.V.) sedation requirements in adult patients undergoing breast surgery under paravertebral (PV) block. The hypothesis is that VR will serve as an effective distraction in the operative context, reducing the need for pharmacology. In parallel, multiple secondary objectives will also be explored, such as the evaluation of the tolerance to the VR headset, the impact of the chosen type of scenario on the primary outcome, the incidence of adverse effects, the variation of the Nociception Level Index (NOL index) in awake patients as well as overall patient satisfaction.
This single center, open-label, randomized controlled trial will be conducted in a Canadian academic hospital. 100 patients above the age of 18 years undergoing breast surgery (mastectomy, reduction, augmentation, reconstruction, etc.) under regional anesthesia, specifically paravertebral block, will be included in this study. Patients will be randomized either to the intervention group or the control group. The intervention group will have a VR helmet and the control group a standard treatment. Both will have access to patient-controlled sedation (PCS), self-administering their own sedation under clinical observation. Patients in the VR group will be able to choose, before the procedure begins, between 3 different VR environments and will also be allowed to switch between these environments during the surgery. The primary outcome of this study will be the time-weighted dose of propofol (sedative) self-administered during the procedure. Secondary outcomes will include patient satisfaction, premature removal of VR helmet, presence of nausea, desaturation, hypotension and post-anesthesia monitoring time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After the participants meet all the inclusion criteria and meet no exclusion criteria, patients will then be randomized by an unbiased algorithm in a 1 for 1 ratio (one control patient for each patient in the virtual reality group). However, the chosen scenario in the virtual reality group will be a result of each patient's personal preference; the patients will also be able to switch between scenarios at will.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality headsetPatients assigned to use a virtual reality headset during their surgery. |
| Control | Active comparator | Other: Standard of careStandard of care group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fully consented female patients above the age of 18 years;
- Undergoing elective, awake, breast surgery performed under paravertebral block.
Key exclusion criteria (5 listed)
- Hearing or visual impairment;
- History of epilepsy, seizure or severe dizziness;
- Severe mental impairment;
- Recent eye or facial surgery or wounds;
- Inability to use the VR hand controller.
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 headsetA brief overview of all three virtual reality scenarios will be shown in a consolidated video prior to letting the participant select the preferred scenario. The participant's choice of scenario will then be documented. Once paravertebral blocks are completed and the participants are in supine position and the surgeon is ready to disinfect, the VR headset will be applied on the face of the participants in the intervention group and the chosen scenario will be started. If at any point the patient expresses a desire to stop using VR during the surgery, we will first offer them an alternate scenario. If they reiterate their willingness to stop, with or without having experienced the new scenario, the headset will be removed for the remainder of the surgery. | Device | Virtual reality |
| Standard of careStandard of care in anesthesia with patient-controlled sedation. | Other | Control |
Primary outcome
Propofol self-administration
Time frame: Between 1 hour and 3 hours
Time-adjusted and weight-adjusted average self-administration of propofol in mcg/kg/min in female patients undergoing breast surgery under paravertebral block.
14 secondary outcomes
Preoperative anxiety
Time frame: Up to 1 hour
Remifentanil administration
Time frame: Between 1 hour and 3 hours
Ketamine administration
Time frame: Between 1 hour and 3 hours
Adverse events
Time frame: Between 1 hour and 3 hours
Scenario switches
Time frame: Between 1 hour and 3 hours
Virtual reality usage
Time frame: Between 1 hour and 3 hours
Virtual reality usage per first scenario
Time frame: Between 1 hour and 3 hours
Virtual reality headset removal
Time frame: Between 1 hour and 3 hours
Post-Anesthesia Care Unit stay
Time frame: Between 30 minutes and 2 hours
Enthusiasm at the idea of using virtual reality
Time frame: Up to 1 hour
Ease of use
Time frame: Between 30 minutes and 2 hours
Enjoyment of the first scenario chosen
Time frame: Between 30 minutes and 2 hours
Overall satisfaction
Time frame: Between 30 minutes and 2 hours
NOL index readings
Time frame: Between 1 hour and 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 38269073Boutin J, Kamoonpuri J, Faieghi R, Chung J, de Ribaupierre S, Eagleson R. Smart haptic gloves for virtual reality surgery simulation: a pilot study on external ventricular drain training. Front Robot AI. 2024 Jan 10;10:1273631. doi: 10.3389/frobt.2023.1273631. eCollection 2023.
- Background: PubMed 37870233Boyce L, Jordan C, Egan T, Sivaprakasam R. Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. Pain. 2024 Apr 1;165(4):741-752. doi: 10.1097/j.pain.0000000000003086. Epub 2023 Oct 23.
- Background: PubMed 31136330Eijlers R, Utens EMWJ, Staals LM, de Nijs PFA, Berghmans JM, Wijnen RMH, Hillegers MHJ, Dierckx B, Legerstee JS. Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. Anesth Analg. 2019 Nov;129(5):1344-1353. doi: 10.1213/ANE.0000000000004165.
- Background: PubMed 35976578Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17.
- Background: PubMed 34908872Gelinas C, Shahiri T S, Richard-Lalonde M, Laporta D, Morin JF, Boitor M, Ferland CE, Bourgault P, Richebe P. Exploration of a Multi-Parameter Technology for Pain Assessment in Postoperative Patients After Cardiac Surgery in the Intensive Care Unit: The Nociception Level Index (NOL)TM. J Pain Res. 2021 Dec 7;14:3723-3731. doi: 10.2147/JPR.S332845. eCollection 2021.
- Background: PubMed 36769490Hitching R, Hoffman HG, Garcia-Palacios A, Adamson MM, Madrigal E, Alhalabi W, Alhudali A, Sampaio M, Peterson B, Fontenot MR, Mason KP. The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review. J Clin Med. 2023 Jan 20;12(3):843. doi: 10.3390/jcm12030843.
- Background: PubMed 32092098Huang MY, Scharf S, Chan PY. Effects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial. PLoS One. 2020 Feb 24;15(2):e0229320. doi: 10.1371/journal.pone.0229320. eCollection 2020.
- Background: PubMed 29750696Kreienbuhl L, Elia N, Pfeil-Beun E, Walder B, Tramer MR. Patient-Controlled Versus Clinician-Controlled Sedation With Propofol: Systematic Review and Meta-analysis With Trial Sequential Analyses. Anesth Analg. 2018 Oct;127(4):873-880. doi: 10.1213/ANE.0000000000003361.
- Background: PubMed 38511201Kuhn AW, Yu JK, Gerull KM, Silverman RM, Aleem AW. Virtual Reality and Surgical Simulation Training for Orthopaedic Surgery Residents: A Qualitative Assessment of Trainee Perspectives. JB JS Open Access. 2024 Mar 20;9(1):e23.00142. doi: 10.2106/JBJS.OA.23.00142. eCollection 2024 Jan-Mar.
- Background: PubMed 26884890Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.
- Background: PubMed 1872456Rudkin GE, Osborne GA, Curtis NJ. Intra-operative patient-controlled sedation. Anaesthesia. 1991 Feb;46(2):90-2. doi: 10.1111/j.1365-2044.1991.tb09345.x.
- Background: PubMed 36192000Ryu S, Kitagawa T, Goto K, Okamoto A, Marukuchi R, Hara K, Ito R, Nakabayashi Y. Intraoperative Holographic Guidance Using Virtual Reality and Mixed Reality Technology During Laparoscopic Colorectal Cancer Surgery. Anticancer Res. 2022 Oct;42(10):4849-4856. doi: 10.21873/anticanres.15990.
- 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.
Pascal Laferriere-Langlois, MD, MSc principal investigator
Ciusss de L'Est de l'Île de Montréal
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 headset in people with Virtual Reality and Propofol, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Laferriere-Langlois, MD, MSc (+1 (819) 432-5847, pascal.laferriere-langlois@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol self-administration (time frame: Between 1 hour and 3 hours). 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 NCT06522711, which also lists 16 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 26 Jul 2024.