Status:
COMPLETED
Evaluation of the Effectiveness of Virtual Reality as an Adjunct to Standard Care in Managing Perioperative Anxiety and Pain in Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia
Lead Sponsor:
University of Sfax
Conditions:
Perioperative Anxiety
Perioperative Pain Management
Eligibility:
All Genders
19-64 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate whether virtual reality (VR) can effectively reduce perioperative anxiety and pain in patients undergoing lower limb orthopedic surgery under spinal anes...
Detailed Description
This randomized controlled clinical trial investigates the effect of immersive virtual reality (VR) on the management of perioperative anxiety and pain in patients undergoing elective lower limb ortho...
Eligibility Criteria
Inclusion
- \- Inclusion Criteria :
- Age between 19 and 64 years
- American Society of Anesthesiologists (ASA) physical status classification I or II (Annex 1)
- Scheduled for lower limb orthopedic surgery under spinal anesthesia
- Provided informed consent to participate in the study
- Non-Inclusion Criteria :
- Patient refusal to participate in the study
- Contraindications to virtual reality (VR) (Patients with cognitive or psychiatric disorders, Claustrophobia, Uncontrolled epilepsy, Visual and/or auditory impairments preventing the use of VR)
- Contraindications to midazolam: known hypersensitivity to benzodiazepines or any excipient of the product
- Patients currently taking anxiolytic medications
- Contraindications to regional anesthesia (spinal anesthesia), (Coagulation disorders, Shock or uncompensated hypovolemia, Unstable arterial hypertension, Decompensated heart failure, Severe aortic or mitral stenosis, Intracranial hypertension, Infection near the puncture site, Progressive neurological disorders, Allergy to local anesthetics, Technical difficulties in performing spinal anesthesia)
Exclusion
- Failure of spinal anesthesia requiring conversion to general anesthesia
- Occurrence of an anesthetic or surgical complication
- Occurrence of an adverse effect related to virtual reality, such as (Dizziness, Ocular or muscular contractions triggered by light stimulation, Signs of discomfort : eye strain, blurred vision, disorientation, imbalance, anxiety attack, headache, nausea, vomiting)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07134764
Start Date
September 1 2024
End Date
July 30 2025
Last Update
August 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Habib Bourguiba University Hospital
Sfax, Tunisia, 3000