NCT07130084 Virtual Reality in Elective Caesarean Births Study (VREC)

Eligibility & Interventions

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This trial targets 40 participants in total. It began in 2024-10-14 with a primary completion date of 2025-09-01.

Brief Summary

This study will establish the safety of a known intervention in a novel setting. It will assess how maternal anxiety during the peri-operative period of an elective cesarean section (eCS) is affected by the introduction of a virtual reality (VR) tool. A cesarean section is the most common operation performed in the world. Indeed, locally, we perform approximately 450 eCS annually, equating to 10% of all births. High maternal anxiety in the peri-operative period is well recognised. Although anxiety is considered to be an emotional response it has many physiological consequences which can confer significant morbidity. These include an increased pain perception (with higher analgesic requirement), increased length of hospital stay and a higher risk of infection. Providing high-quality pre-operative information to help patients reduce their anxiety has been used in other medical fields. The use of VR to deliver this information to paediatric populations has been shown to be particularly effective. VR has had limited scope outside of this population and we wish to change this. Women booked for an eCS at the Royal United Hospital (RUH) will be eligible to participate. A bespoke VR tool (a video of a woman's journey through the process of an elective section at the RUH) will be shown to one group of women prior to eCS whilst another group will receive the standard preoperative information. A series of quantitative and qualitative data points will be collected across both groups assessing their anxiety and satisfaction with the birthing process throughout the peri-operative period. The two groups will then be compared. Recruitment will occur prior to the birth during scheduled appointments with the Midwifery team. If proven to be a safe intervention, we hope to run a larger study aiming to determine the efficacy and role of VR in improving maternal outcomes in cesarean births.

Eligibility Criteria

Inclusion Criteria: * Have had the decision for elective LSCS by 38 weeks gestation. * Has never had an emergency or elective section previously * Have a procedure planned and performed as a category 4 LSCS (an elective LSCS booked at a time that suits both the woman and obstetric team) * Have use of an android or iOS operating system smartphone or tablet device. * Have access to the internet. * Have an active email address. * Have capacity to consent to participate in the study. Exclusion Criteria: * Patient \<18 years of age * Patient refusal * Patients who have had an emergency or elective LSCS previously. * Patients with a history of anxiety disorders * Patients with medical or obstetric co-morbidities requiring pre-determined admission to maternity HDU care * Congenital structural abnormalities requiring pre-determined admission to NICU * Patients where spinal anaesthesia is contra-indicated * Women who have English of an insufficient standard to comprehend the consent and assessment process * Prisoners

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