Effect of Virtual Reality on the Need of Premedication Before Surgery

Ente Ospedaliero Cantonale, Bellinzona40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Anxiety Premedication Surgery Virtual Reality

Interventions

The 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Injuries to the head/face that would prohibit wearing headsets * Infectious skin conditions of the head/face * Contact isolation due to bacteria and viruses * Symptoms of vertigo or motion sickness * Reduced visual or auditory acuity * Pregnancy * Claustrophobia

Outcomes

Primary Outcomes

Proportion of patients requiring pharmacological premedication after Virtual Reality (VR) intervention

Time frame: Up to the initiation of pre-oxygenation (same day)

Secondary Outcomes

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)

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)

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)

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 extubation

Compliance with the VR intervention

Proportion of patients who required the interruption of the VR intervention

Time frame: From the beginning of the intervention up to the end of the intervention (planned duration of the intervention: 20 minutes)

Post-operative evaluation of patient's satisfaction regarding pre-operative period

Evaluation of patient's satisfaction regarding the pre-operative period with a 5 points Lickert scale (from 1 to 5) with 1 beeing the lowest perceived level of satisfaction

Time frame: From 4 hours after patient's extubation up to 72 hours after patient's extubation

Incidence of cyberslckness

Symptoms of cybersickness such as disorientation, dizziness, eye problems (fatigue, blurred vision, headache) will be monitored

Time frame: From the beginning of the VR intervention up to 15 minutes after the end of the VR intervention

Incidence of secondary effects linked to the use of anxiolytic premedication

For patients requesting a premedication, secondary effects like cognitive impairment, sedation, respiratory depressions will be registered

Time frame: From administration of anxiolytic medication until initiation of pre-oxygenation (same day)

Time to Administration of Anxiolytic Premedication

After the study intervention, patient will be asked if he still wants to assume anxiolytic premedication. In case of positive answer, anxiolytic premedication will be given and time will be noted. In case of negative answer, no anxiolytic premedication will be given. In the following moments, in case of change in patient's anxiety level with a secondary request of anxiolytic premedication, "rescue" premedication will be given and timing will be noted.

Time frame: Time interval (in minutes) between completion of the VR intervention and administration of anxiolytic premedication, including rescue premedication if applicable.

Change in patient's anxiety over time using Visual Analogue Scale for anxiety scale (VASA)

Change in Visual Analogue Scale for anxiety (VASA) between 3 time points. VASA scale ranges from 0 to10 with 10 corresponding to the highest level of anxiety.