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

NCT07134764 | Completed

• 1 other identifier: FMS-24-11-1999-51-24
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Virtual reality; Perioperative anxiety; Perioperative pain; Orthopedic surgery; Spinal anesthesia; Randomized controlled trial; Lower limb surgery; Hemodynamic stability

Outcome Measures

Primary Outcomes (1)

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

  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

  pre during the intervention and post-intervention

Secondary Outcomes (1)

• 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

Study Arms (2)

VR group

EXPERIMENTAL

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.

Device: Virtual reality session

T group

NO INTERVENTION

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.

Interventions

Virtual reality session 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.

VR group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sfax: lead

Study Sites (1)

Habib Bourguiba University Hospital

Sfax, 3000, Tunisia

Location

MeSH Terms

Conditions

Personal Satisfaction; Postoperative Complications

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Imen Zouche, Professor in Medicine

  University of Sfax

  STUDY DIRECTOR

• Yosra Mejdoub, Professor in Medicine

  University of Sfax

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: Participants will be randomly assigned in parallel to one of two groups: the intervention group receiving virtual reality exposure during the perioperative period, or the control group receiving standard care. Each participant remains in their assigned group throughout the study, and outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When the investigator Publish the Study Article and When the investigator finish Doctoral Studies
• Access Criteria: Researchers who may need this data for future studies

Locations

TU (1)