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

Not Applicable

Completed

• Conditions: Perioperative Anxiety; Perioperative Pain Management; Hemodynamic Stability; Satisfaction; Sedative Consumption; Postoperative Complications

• Registration Number: NCT07134764
• Lead Sponsor: University of Sfax

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 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.

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 orthopedic surgery under spinal anesthesia. The use of VR as a non-pharmacological adjunct is a novel and promising approach intended to improve the patient's perioperative experience, optimize physiological responses, and potentially reduce the consumption of sedatives and analgesics.

Participants in the intervention group will wear a VR headset that delivers immersive, calming visual and auditory content designed to promote relaxation and distraction before, during, and after the surgical procedure. The control group will receive standard care without VR. Both groups will receive spinal anesthesia as part of routine clinical practice.

Anxiety and pain will be measured at predefined perioperative time points using validated visual analog scales (VAS) and APAIS scale. Additional data on hemodynamic parameters, sedative and analgesic consumption, intraoperative complications, and postoperative satisfaction (from patients, surgeons, and anesthetists) will be collected to evaluate the overall impact of VR on perioperative care quality and patient outcomes.

This study is being conducted at Habib Bourguiba University Hospital, Sfax, Tunisia, over a 12-month period and represents the first clinical evaluation of virtual reality technology in an anesthesia context at this institution. The findings may contribute to the integration of digital tools into routine perioperative care, especially in low-resource settings, by demonstrating their utility in reducing stress, improving comfort, and supporting enhanced recovery after surgery.

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-21
• Last Update Posted: 2025-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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, anxiety attack, headache, nausea, vomiting)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of Immersive Virtual Reality on Reducing Perioperative Anxiety in Lower Limb Orthopedic Surgery Under Spinal Anesthesia	pre during the intervention and post-intervention	The inversigator expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: Significantly reduce perioperative anxiety levels compared to standard care

Secondary Outcome Measures

Name	Time	Method
The Effect of Virtual Reality on Perioperative Pain, Sedative Use, and Patient Satisfaction in Orthopedic Surgery Under Spinal Anesthesia	pre during the intervention and post-intervention	The investigator expect that the use of immersive virtual reality (VR) during lower limb orthopedic surgery under spinal anesthesia will: * Lower the intensity of perioperative pain as measured by validated pain scales; * Decrease the need for sedative and analgesic medications during the perioperative period; * Contribute to more stable hemodynamic parameters during and after the procedure; * Increase overall satisfaction among patients, as well as anesthesia and surgical teams

Trial Locations

Locations (1)

Habib Bourguiba University Hospital; 🇹🇳 Sfax, Tunisia