Virtual Reality for Anxiolysis and Pharmacological Sparing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this 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?
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.
Eligibility criteria
Qualifiers
Fully consented female patients above the age of 18 years;
Undergoing elective, awake, breast surgery performed under paravertebral block.
Disqualifiers
Hearing or visual impairment;
History of epilepsy, seizure or severe dizziness;
Severe mental impairment;
Recent eye or facial surgery or wounds;
Trial design
Treatments tested in this trial
- Virtual reality headset
- Standard of care
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Paperplane Therapeutics
Collaborator
Source ClinicalTrials.gov