Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia
- Conditions
- Satisfaction, PatientAnxiety
- Registration Number
- NCT06061198
- Lead Sponsor
- University Hospital, Mahdia
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- patient classified ASA 1 , 2 or 3
- patients undergoing an upper-limb surgery under regional anesthesia
- regional anesthesia failure
- local anesthetics intoxications
- symptoms of cyber-sickness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method hypnovel consumption during surgery From enrollment to the end of treatment at 10 weeks the required dose of Midazolam for a LIKERT intraoperative anxiety score goal \< 2
- Secondary Outcome Measures
Name Time Method satisfaction level during surgery at the end of the procedure satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction
pre-operative patients's anxiety level by LIKERT score From enrollment to the end of treatment at 10 weeks pre operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
pre-operative patients's anxiety level by STAI-6 score From enrollment to the end of treatment at 10 weeks pre operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
per-operative patients's anxiety level by LIKERT score From enrollment to the end of treatment at 10 weeks per operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
vitals : heart rate From enrollment to the end of treatment at 10 weeks vitals were monitored all long the procedure
post-operative patients's anxiety level by LIKERT score From enrollment to the end of treatment at 10 weeks post operative anxiety measured with a LIKERT scale: 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
vitals : oxygen saturation From enrollment to the end of treatment at 10 weeks vitals were monitored all long the procedure
post-operative patients's anxiety level by STAI-6 score From enrollment to the end of treatment at 10 weeks post operative anxiety measured with a STAI-6 modified scale : a total score superior to 65 : high anxiety , score between 56-65 : too high anxiety , score between : 36 - 45 : low anxiety , score inferior to 35 no anxiety
vitals : systolic pressure From enrollment to the end of treatment at 10 weeks vitals were monitored all long the procedure
Trial Locations
- Locations (1)
Taher Sfar University Hospital
🇹🇳Mahdia, Tunisia
Taher Sfar University Hospital🇹🇳Mahdia, Tunisia