Virtual Reality in Elective Caesarean Births Study (VREC)

NCT07130084 | Recruiting

• 1 other identifier: 24/WA/0033
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pregnancy; Pain

Keywords

Virtual reality

Outcome Measures

Primary Outcomes (1)

• patient feedback questionnaire after watching virtual reality education film

  Patients will complete a feedback questionnaire to assess if a pre-operative virtual reality education film is safe, feasible and acceptable intervention in women who have had an elective Cesarean section.

  from enrollment up to 1 weeks post cesarean section

Secondary Outcomes (6)

• State Trait Anxiety Inventory Scale 5

  from enrollment up to 48 hours post cesarean section

• Visual Analogue Scale for Anxiety

  from enrollment up to 48 hours post delivery

• Serum cortisol

  From enrollment up to 48 hours post delivery

• Patient satisfaction scores

  enrollment up to 48 hours post cesarean section

• Visual Analogue Scores (VAS) for pain

  up to 48 hours post cesarean section

Study Arms (2)

Virtual reality educational film

EXPERIMENTAL

The intervention arm will receive the standard antenatal care and pre-operative education plus will view the Virtual Reality Educational Film

Other: Virtual Reality Educational Film

Control arm

NO INTERVENTION

The control arm will receive all standard antenatal care and pre-operative education

Interventions

Virtual Reality Educational Film OTHER

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.

Virtual reality educational film

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead

Study Sites (1)

Bath Birthing Centre, Royal United Hospital Bath Foundation Trust

Bath, BA1 3NG, United Kingdom

RECRUITING

Related Publications (21)

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  BACKGROUND

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  PMID: 16371522 BACKGROUND

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  PMID: 21802628 BACKGROUND

• Navarro-Garcia MA, Marin-Fernandez B, de Carlos-Alegre V, Martinez-Oroz A, Martorell-Gurucharri A, Ordonez-Ortigosa E, Prieto-Guembe P, Sorbet-Amostegui MR, Indurain-Fernandez S, Elizondo-Sotro A, Irigoyen-Aristorena MI, Garcia-Aizpun Y. [Preoperative mood disorders in patients undergoing cardiac surgery: risk factors and postoperative morbidity in the intensive care unit]. Rev Esp Cardiol. 2011 Nov;64(11):1005-10. doi: 10.1016/j.recesp.2011.06.009. Epub 2011 Sep 15. Spanish.

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• Caumo W, Ferreira MB. Perioperative anxiety: Psychobiology and effects in postoperative recovery. Pain Clin 2003;15:87 101.

  BACKGROUND

• Hepp P, Hagenbeck C, Burghardt B, Jaeger B, Wolf OT, Fehm T, Schaal NK; MAGIC Group. Measuring the course of anxiety in women giving birth by caesarean section: a prospective study. BMC Pregnancy Childbirth. 2016 May 18;16:113. doi: 10.1186/s12884-016-0906-z.

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  BACKGROUND

Related Links

• 23\. National Institute for Health and Care Excellence Clinical Excellence, (31st March 2021), Caesarean Birth \[NICE guideline no. 192\]

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Anaesthesia

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: October 14, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)