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

NCT ID: NCT06061198

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-05-18

Brief Summary

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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

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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

Conditions

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Anxiety Satisfaction, Patient

Keywords

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virtual reality anxiety patient satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group of patients who underwent surgery with the virtual reality experience

patients underwent surgery wearing a virtual reality mask

Group Type ACTIVE_COMPARATOR

a virtual reality device

Intervention Type 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

patients who underwent surgery in standard conditions without the virtual reality experience

patients underwent surgery without a virtual reality mask

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Mahdia

OTHER

Sponsor Role lead

Responsible Party

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Majdoub Ali MD

medical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Majdoub Ali MD, professor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Mahdia

Locations

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Taher Sfar University Hospital

Mahdia, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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UHMahdia

Identifier Type: -

Identifier Source: org_study_id