About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient <18 years of age
Patient refusal
Patients who have had an emergency or elective LSCS previously.
Patients with a history of anxiety disorders
Trial design
Parallel
Treatments tested in this trial
Virtual Reality Educational Film
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
State Trait Anxiety Inventory Scale 5
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of anxiety. It has 5 items for assessing anxiety. Each item is self rated on a score or 1-4 (1= not at all; 4=very much so). Item statements are: 'I feel upset', 'I feel frightened', 'I feel nervous', 'I feel jittery', and 'I feel confused'. STAI is completed at 5 time points (T1 at pre-clerking (approximately 38-39 weeks gestation), T2 on admission for LSCS, T3 at skin closure, T4 2 hour's post-LSCS, T5 at 24 hours post-LSCS patient will be phoned if they have left the hospital).
Visual Analogue Scale for Anxiety
VAS-A is a validated, self-reported instrument assessing anxiety. Participants are asked to indicate their level of anxiety on a scale from 0-10 (number 0 indicates no anxiety and the number 10 indicates severe anxiety) VAS-A at 5 time points (T1 at pre-clerking approximately 38-39 weeks gestation, T2 on admission for LSCS, T3 at skin closure, T4 2 hours post-LSCS, T5 at 24 hours post-LSCS patient will be phoned if they have left the hospital ) (Score 0-10).
Serum cortisol
Cortisol is a hormone and levels can alter depending on the stress response. It requires a blood test and will be measured at 4 time points (T1 at pre-clerking at approximately 38-39 weeks gestation, T2 on admission for LSCS, T3 at skin closure, T4 at 2 hours post-LSCS)
Patient satisfaction scores
Participants are asked to rate their satisfaction on the care they received on a scale 0 -10, where 0 is very poor and 10 is extremely satisfied. Scores at two time points (T4 at 2 hours post-LSCS and T5 at 24 hours post-LSCS, patient will be phoned if they have left the hospital)(Score 0-10)
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