Seniors' Intraoperative Management Under Locoregional Anesthesia Integrating Virtual Reality
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
This study aims to evaluate the acceptability of intraoperative virtual reality in elderly patients under spinal anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully consented patients over 65 years old
Undergoing elective surgery that requires spinal anesthesia.
Disqualifiers
Hearing or visual impairment
History of epilepsy, seizure, or severe dizziness
Severe mental impairment
Recent eye or facial surgery or wounds
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality Headset
DeviceThe virtual reality headset, which will display one of the 3 available scenarios, will be placed on the patient head during a surgery under spinal anesthesia.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: a group of 55 patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient's tolerance to headset
The primary endpoint is the patient's tolerance to virtual reality defined by the headset to be worn for more than or equal to 30 minutes by the participant
Time frame
Intraoperative (from T0 = the patient puts on the headset until Tend = 30 minutes after T0)Secondary outcomes
1
Anxiety before the surgery
Level of anxiety before the surgery evaluated by the Amsterdam Preoperative Anxiety and Information Scale (a scale from 1 - not at all to 5 - extremely, 6 questions).
Time frame
preoperative (from T0 = the patient arrives at the hospital the morning of the surgery until Tend = the patient enters the operating room, about 2 hours)2
Total of time before the patient's first request to interrupt the experiment
The total time in minutes, both in absolute and relative to the duration of the surgery, from the start of the initially chosen scenario to the first request to interrupt the experiment.
Time frame
intraoperative (from T0 = the patient puts on the headset at the beginning of the surgery until Tend = the patient first asks to interrupt the experiment during the surgery, about 45 minutes - depending on the person and the surgery)3
Total of time during which the patient wears the VR headset during surgery.
The total time in minutes, both in absolute and relative to the duration of the surgery, from the start of the initially chosen scenario to the headset removal
Time frame
intraoperative (from T0 = the patient puts on the headset and starts the initially chosen scenario until Tend = the patient takes off the headset, about 45 minutes - depending on the person and the surgery)4
Time spent on each scenario and the order in which they were presented
Compare the total duration in minutes the patient wore the headset depending on the type of scenario chosen, and the order in which they were presented
Time frame
intraoperative (from T0 = the patient starts the first scenario until Tend = he asks to change the scenario) - for each scenario, about 45 minutes - depending on the person and the surgerySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: