Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia
Condition: Anxiety; Satisfaction, Patient
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      this study was conducted in TAHER SFAR Hospital . it included 68 patients and it aims to
      evaluate the impact of virtual reality on patients undergoing upper limb surgery under
      regional anesthesia and evaluate the consumption of hypnotics during surgery , anxiety levels
      and patients satisfaction. this study contain 2 arms , each arm contain 34 patients . first
      arm received regional anesthesia and surgery under virtual reality using a VR gear . second
      arm received standard care
    

Detailed description: 
      patients who had surgery with the virtual reality experience or the VR- group ( group of
      patients who had surgery with standard measures without virtual reality) The patient was
      setup comfortably on the operating table.The echo-guided regional anesthesia appropriate to
      the surgical procedure is performed by an experienced anesthesiologist.In the RV+ patients,
      loco regional anesthesia was performed before installing the VR mask and before initiating
      immersing in the virtual reality space. anesthesia protocol was performed before initiating
      VR experience to maintain audiovisual and cognitive contact with the patient and detect
      possible complications For the virtual reality immersion for the VR+ group, we used an OCULUS
      SAMSUNG GEAR VR, a virtual reality headset connected to a SAMSUNG S7 Edge phone with
      headphones.The headset was worn after the loco regional anesthesia and removed at the end of
      the procedure.The helmet is adapted to each patient according to his head circumference
      measurements and the image adjustment is personalized.The VR session consists of an immersion
      in a natural relaxation environment produced by an application downloaded from the OCULUS
      STORE: VR Guided Meditation.The application offers a choice of 4 environments: Relaxing day
      on a tropical beach, beautiful sunset beach, mountain sunrise, or forest nap experiences .
      The choice of the environment is randomized according to the patient's preferences.For
      patients who belongs to the VR- group, the procedure was performed under standard conditions
      with a drape separating the patient from the operating site During surgery, the vital signs:
      HR, PANI, SpO2 were collected at the different peri-operative moments respectively at the
      entrance to the operating room (T0), 15 minutes after ALR (T1), 30 minutes after ALR (T2), 30
      minutes (T3), 1 hour (T4) and 2 hours (T5) An intraoperative assessment of anxiety was
      performed after 15 minutes of ALR, i.e. at T1 by the LIKERT scale The anesthesist could
      administer anxiolytics outside of the contraindications. The molecule of choice is Midazolam
      and the dose taken is noted on the data collection form The administration of anxiolytics
      (Midazolam) is judged by clinical criteria determined in the protocol:- Anxiety during the
      operation judged as painful or important (higher than2 on the LIKERT scale) The session can
      be interrupted during the procedure for medical reasons or at the patient's request.If the
      local anesthesia fails and the patient is converted to general anesthesia, the protocol is
      cancelled and a standard induction is performed by the anesthesiologist.The events of
      desaturation (SpO2 < 90%), apnea, administration of anxiolytics administration of anxiolytics
      (to reach a minimal level of anxiety) were indicated on the data collection form.For both RV+
      and RV- groups, postoperative anxiety was assessed using the scores:1- Postoperative STAI at
      H1 postoperative2- patient satisfaction evaluated by a LIKERT scale
    

Intervention name(s): a virtual reality device
Intervention type(s): Device
Intervention description(s): the patient will wear a masque tht will provide a virtual reality experience using a VR Gear connected to a mobile phone through an application installed on the mobile phone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 arms are involved in the study . first arm will receive local anesthesia with virtual reality during the surgery to reduce patient's anxiety . second arm will receive standards care under regional anesthesia
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: virtual reality; anxiety; patient satisfaction