An interventional study of a virtual reality device in Anxiety and Satisfaction, Patient, sponsored by University Hospital, Mahdia. Completed at 1 site in Tunisia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by University Hospital, Mahdia · Not applicable, Interventional, and Supportive care
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
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
877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.
This study's enrollment of 68 is below the median of 96 across 624 interventional studies indexed under Patient Satisfaction.
Browse Patient Satisfaction studies →University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.
Compared within Patient Satisfaction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients underwent surgery wearing a virtual reality mask
Device: a virtual reality device
patients underwent surgery without a virtual reality mask
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
hypnovel consumption during surgery
the required dose of Midazolam for a LIKERT intraoperative anxiety score goal \< 2
Time frame: From enrollment to the end of treatment at 10 weeks
satisfaction level during surgery
satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction
Time frame: at the end of the procedure
pre-operative patients's anxiety level by LIKERT score
pre operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time frame: From enrollment to the end of treatment at 10 weeks
per-operative patients's anxiety level by LIKERT score
per operative anxiety measured with a LIKERT scale : 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time frame: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by LIKERT score
post operative anxiety measured with a LIKERT scale: 1= no anxiety , 2: tolerable anxiety , 3= anxious ; 4= hard experience
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : systolic pressure
vitals were monitored all long the procedure
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : heart rate
vitals were monitored all long the procedure
Time frame: From enrollment to the end of treatment at 10 weeks
vitals : oxygen saturation
vitals were monitored all long the procedure
Time frame: From enrollment to the end of treatment at 10 weeks
pre-operative patients's anxiety level by STAI-6 score
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
Time frame: From enrollment to the end of treatment at 10 weeks
post-operative patients's anxiety level by STAI-6 score
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
Time frame: From enrollment to the end of treatment at 10 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Mahdia