Effect of Virtual Reality on the Need of Premedication Before Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEnte Ospedaliero Cantonale, Bellinzona
About this trial
This study will assess, on patients requesting a pharmacological premedication in the preoperative period, if virtual reality reality could reduce the request of pharmacological premedication while maintaining a good level of comfort for the patient. The aim of this study is to understand if virtual reality could reduce the need for pharmacological premedication and their associated secondary effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing elective surgery
Minimal age of 18-year-old
Able to give informed consent for the study
Requesting pharmacological premedication in the pre-operative period.
Disqualifiers
Lacking capacity or ability to complete the consent form or to respond to the required obligations linked to the study protocol
Contraindications to pharmacological premedication
Known cognitive dysfunction, previous history of neurological/psychiatric diseases like epilepsy
Non Italian speaking patients
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality
DeviceThe study intervention will take place on the day of surgery, in the ward, once patient's pre-operative preparation has been completed. The virtual reality device will be started according to the choices made by the patient (scenario and music) for a 20 min session. During that time, the patient will be left at rest and the interactions with the patient will be limited as much as possible.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Virtual reality armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention
Time frame
Up to the initiation of pre-oxygenation (same day)Secondary outcomes
1
Richmond Agitation Sedation Score (RAAS)
The Richmond Agitation-Sedation Scale (RASS) will be used to assess the level of agitation and sedation in study participants. RASS is a validated 10-point scale ranging from -5 (unarousable) to +4 (combative), with 0 representing alert and calm. Negative scores indicate increasing levels of sedation, while positive scores indicate increasing agitation.
Time frame
Prior to initiation of pre-oxygenation (intraoperative period, same day)2
Evaluation of Pa02 and PaC02 in theater
In the operative room, Pa02 and PaC02 (both in mmHg) will be extracted from the first arterial blood gas after insertion of arterial line while the patient is not under oxygen
Time frame
Immediately after arterial line insertion and prior to initiation of pre-oxygenation (same day)3
External evaluation of patient's comfort
External evaluation by the anesthetist team of preceived patient's comfort in theater with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived comfort
Time frame
At end of induction, after airway securement (same day)4
Post-operative qualitative survey
At least 4 hours after the end of anesthesia and patient's extubation, a qualitative survey will be conducted on patient's experience in the preoperative period
Time frame
From 4 hours after patient's extubation up to 72 hours after patient's extubationSponsors and contacts
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Source ClinicalTrials.gov