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Virtual Reality in Elective Caesarean Births Study (VREC)

NCT07130084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Virtual Reality Educational Film

The Virtual Reality Educational Film will be viewed during the antenatal appointment, post randomisation. The women will have access to the film at home should they want to watch it more than once.

Sponsors & Collaborators

  • Royal United Hospitals Bath NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT07130084 on ClinicalTrials.gov