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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-21

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • University of Sfax

    lead OTHER

Principal Investigators

  • Imen Zouche, Professor in Medicine · University of Sfax

  • Yosra Mejdoub, Professor in Medicine · University of Sfax

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-06-30
Completion
2025-07-30

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07134764 on ClinicalTrials.gov