Impact of Virtual Reality on Patient's Anxiety Who Underwent Surgery Uner Regional Anesthesia

Anxiety Clinical Trial

— VRanxiety  

Official title:

Impact of Virtual Reality on Patient's Anxiety During Upper Limb Surgery Under Regional Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06061198
• Other study ID #: UHMahdia
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 18, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Mahdia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 18, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Satisfaction, Patient

Intervention

Device:
• a virtual reality device
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

Locations

Country	Name	City	State
Tunisia	Taher Sfar University Hospital	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypnovel consumption during surgery	the required dose of Midazolam for a LIKERT intraoperative anxiety score goal < 2	From enrollment to the end of treatment at 10 weeks
Secondary	satisfaction level during surgery	satisfaction levels measured with a LIKERT scale : 1 : not satisfied , 2: low satisfaction , 3:satisfied , 4: great satisfaction	at the end of the procedure
Secondary	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	From enrollment to the end of treatment at 10 weeks
Secondary	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	From enrollment to the end of treatment at 10 weeks
Secondary	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	From enrollment to the end of treatment at 10 weeks
Secondary	vitals : systolic pressure	vitals were monitored all long the procedure	From enrollment to the end of treatment at 10 weeks
Secondary	vitals : heart rate	vitals were monitored all long the procedure	From enrollment to the end of treatment at 10 weeks
Secondary	vitals : oxygen saturation	vitals were monitored all long the procedure	From enrollment to the end of treatment at 10 weeks
Secondary	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	From enrollment to the end of treatment at 10 weeks
Secondary	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	From enrollment to the end of treatment at 10 weeks