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NCT07134764
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
NA trial testing Virtual reality session in Perioperative Anxiety in 120 participants. Completed in 30 July 2025.
30 June 2025
Quick facts
| Lead sponsor | University of Sfax |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 September 2024 |
| Primary completion | 30 June 2025 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- Virtual reality session
Conditions studied
- Perioperative Anxiety — all drugs for Perioperative Anxiety →
- Perioperative Pain Management — all drugs for Perioperative Pain Management →
- Hemodynamic Stability — all drugs for Hemodynamic Stability →
- Satisfaction — all drugs for Satisfaction →
Sponsor
University of Sfax
Who can join
Adults 19 to 64, any sex, with Perioperative Anxiety or Perioperative Pain Management. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07134764
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Virtual reality session
Trials testing the same drug.
- NCT05590078 — Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery · NA · completed
Other recruiting trials for Perioperative Anxiety
Currently open trials in the same condition.
- NCT07270029 — Sensory Toys for Anxiety Reduction - Can Fidget Toys Improve Stress and Help Children to Cope Before Surgery (STARFISH) · NA · recruiting
- NCT07206186 — Effect of Music on Patient Comfort · NA · recruiting
Other University of Sfax trials
Trials by the same sponsor.
- NCT07123311 — Implementation and Evaluation of an Internet-Based Stress Management Program for Health Students in the Sfax Region · NA · not yet recruiting
- NCT07140185 — Impact of a Physical Activity Intervention on Sleep Quality, Mental and Physical Well-Being in Health Sciences Students · NA · not yet recruiting
- NCT07303088 — Effects of L-carnitine and Coenzyme Q10 Supplementation on Oxidative Stress in Tunisian Hemodialysis Patients. · NA · completed
- NCT07046871 — Effectiveness of Adapted Basketball Programs in Adolescents With Obesity (ABBA) · NA · completed
- NCT07584785 — Mediterranean Diet and Progressive Resistance Training Effects on BMD and Bone Turnover in the Elderly · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07134764 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sfax
- Last refreshed: 21 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07134764.
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