Clinical trial NCT06061198: Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia
Official title: Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Satisfaction, Patient
Keywords: virtual reality
anxiety
patient satisfaction
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: Inclusion Criteria:

* patient classified ASA 1 , 2 or 3
* patients undergoing an upper-limb surgery under regional anesthesia

Exclusion Criteria:

* regional anesthesia failure
* local anesthetics intoxications
* symptoms of cyber-sickness

Primary outcomes:
measure: hypnovel consumption during surgery
timeFrame: From enrollment to the end of treatment at 10 weeks
Secondary outcomes:
measure: satisfaction level during surgery
timeFrame: at the end of the procedure
measure: pre-operative patients's anxiety level by LIKERT score
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: per-operative patients's anxiety level by LIKERT score
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: post-operative patients's anxiety level by LIKERT score
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: vitals : systolic pressure
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: vitals : heart rate
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: vitals : oxygen saturation
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: pre-operative patients's anxiety level by STAI-6 score
timeFrame: From enrollment to the end of treatment at 10 weeks
measure: post-operative patients's anxiety level by STAI-6 score
timeFrame: From enrollment to the end of treatment at 10 weeks
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Taher Sfar University Hospital
Study officials:
affiliation: University Hospital, Mahdia
name: Majdoub Ali MD, professor
role: PRINCIPAL_INVESTIGATOR
References: