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

NCT ID: NCT07134764

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-07-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

VR group

Participants in the experimental group will receive an immersive virtual reality (VR) session as an adjunct to standard perioperative care. A SHINECON VR headset will be used to deliver calming or distraction-based visual and auditory content during the entire duration of the orthopedic surgery under spinal anesthesia. The session aims to reduce anxiety and pain perception, minimize the need for sedatives and analgesics, enhance hemodynamic stability, and improve patient and healthcare team satisfaction.

Group Type: EXPERIMENTAL

Virtual reality session

Intervention Type: DEVICE

Patients included in the intervention group (VR group) participated in a comprehensive virtual reality program designed to reduce perioperative anxiety and pain. Prior to their surgery, they attended an introductory VR session aimed at familiarizing them with the technology and providing a calming, immersive environment to help alleviate preoperative stress. Throughout their surgical journey, these patients continued to receive the usual standard care, which included thorough preoperative consultations with healthcare providers, detailed information about the planned surgical procedure, and the provision of standard postoperative care to support recovery. Additionally, during the surgery itself, patients underwent a VR session delivered via a headset, offering real-time immersive distraction and relaxation to minimize intraoperative anxiety and pain perception.

T group

Participants in the control group will receive standard perioperative care as per institutional protocol during orthopedic surgery under spinal anesthesia. No virtual reality device or additional non-pharmacological intervention will be administered. Anxiety, pain, hemodynamic stability, sedative and analgesic use, and satisfaction will be evaluated and compared to the experimental group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual reality session

Patients included in the intervention group (VR group) participated in a comprehensive virtual reality program designed to reduce perioperative anxiety and pain. Prior to their surgery, they attended an introductory VR session aimed at familiarizing them with the technology and providing a calming, immersive environment to help alleviate preoperative stress. Throughout their surgical journey, these patients continued to receive the usual standard care, which included thorough preoperative consultations with healthcare providers, detailed information about the planned surgical procedure, and the provision of standard postoperative care to support recovery. Additionally, during the surgery itself, patients underwent a VR session delivered via a headset, offering real-time immersive distraction and relaxation to minimize intraoperative anxiety and pain perception.

Intervention Type: DEVICE

Eligibility 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
• 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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sfax

OTHER

Sponsor Role: lead

Responsible Party

Fedi Ben Dhaou

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imen Zouche, Professor in Medicine

Role: STUDY_DIRECTOR

University of Sfax

Yosra Mejdoub, Professor in Medicine

Role: STUDY_DIRECTOR

University of Sfax

Locations

Habib Bourguiba University Hospital

Sfax, , Tunisia

Countries

Tunisia

Other Identifiers

FMS-24-11-1999-51-24

Identifier Type: -

Identifier Source: org_study_id