NCT06622408

Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS

Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study (Virtual Reality and Schedulded Cesarean Section)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Cesarean deliveries account for 20.7% of all deliveries in France, according to the latest perinatal survey. At Nice University Hospital, the C-section rate over the last 5 years is around 19%. Caesarean section patients are at greater risk of developing symptoms of anxiety, stress and depression. The post-operative period is also more painful, and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain. Numerous attempts to reduce these symptoms have been evaluated, including music therapy, relaxation techniques, acupressure and the use of preoperative melatonin. Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines, notably pediatric surgery and neurosurgery. In particular, several trials have demonstrated a reduction in anxiety in the paediatric population and, for pelvic procedures under local anaesthetic, during prostate biopsies or hysteroscopy in consultation, with a reduction in anxiety and pain respectively. It has been used to provide information by showing a film about the caesarean section procedure, and has been shown to be effective in terms of patient satisfaction, but without being able to demonstrate a significant reduction in anxiety (p=0.06). The use of virtual reality during the entire peri- and intra-operative management process (maternity stay, patient transfer to the operating room, locoregional anesthesia procedure and during the operation) has not been studied in the context of cesarean section.

Conditions

• Women's Health
• Perinatal Care
• Cesarean
• Analgesia

Interventions

Type	Name	Description
OTHER	HypnoVR© virtual reality headset	Adherence to the use of the virtual reality headset will be reported by a percentage of use at each stage of care.

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-10-02
• Last updated: 2026-03-27

Locations

1 site across 1 country: France