CompletedNot Applicable

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

Tunisia120 participantsStarted 2024-09-01

Plain-language 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 anesthesia. The study focuses on adult patients in a surgical setting, with an emphasis on improving intraoperative experience and postoperative outcomes without relying solely on pharmacological interventions. The main questions it aims to answer are: * Can VR reduce perioperative anxiety and perceived pain levels? * Does the use of VR lower the need for sedative and analgesic medications and improve hemodynamic stability and satisfaction? Researchers will compare a VR intervention group to a standard care group to see if VR leads to reduced anxiety and pain, less medication use, better physiological stability, and improved satisfaction. Participants will: * Undergo orthopedic surgery under spinal anesthesia. * Be randomly assigned to either receive standard perioperative care or standard care plus VR immersion. * In the VR group, engage in calming, immersive virtual environments during the perioperative period.

Who can participate

Age range

19 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- 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 Criteria: * 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,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Impact of Immersive Virtual Reality on Reducing Perioperative Anxiety in Lower Limb Orthopedic Surgery Under Spinal Anesthesia

Timeframe: pre during the intervention and post-intervention

Trial details

NCT IDNCT07134764

SponsorUniversity of Sfax

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Perioperative Anxiety trials