Description

The Royal College of Obstetrics and Gynaecology (RCOG) has a well-defined framework for involving pregnant women in research studies (clinical governance document 6a). They promote research in obstetrics but stress the key is that research should be completed 'with women, not on women'. For each step of the study, the RCOG framework will be adhered to.

Overview of the study and why it is important

An elective caesarean section (eCS) can be a very anxiety inducing time. Prior to the research project commencing, we developed a questionnaire that all women at Royal United Hospital, Bath (RUH) completed prior to their eCS. This demonstrated consistently high anxiety levels across obstetric populations, including those who had previous emergency caesarean sections. The main source of anxiety was often a fear 'of the unknown' and not knowing what to expect.

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 post-operative wound infection.

The purpose of this study is to assess the safety of a virtual reality education film (VREF). The VR will provide a 360degree, 3-dimensional virtual tour demonstrating what will happen on their day of delivery, from entering Bath Birthing Centre through to being on the postnatal ward with their new baby. They will be able to watch this, if they choose, using a head set to make the experience more realistic. The ultimate purpose of the film is to reduce that fear of the unknown by giving patients and their families a detailed view of their upcoming journey.

Given the prevalence of high maternal anxiety and the potential emotional and physical costs of anxiety, it is important to try and develop new interventions to reduce this. However, the safety of any potential intervention is paramount. This study will assess the safety of our VREF.

Step 1: Creating the virtual reality video and writing the script RCOG states that service users should be involved in the development and delivery of the trial. We have already addressed this by involving patients via our PPI (patient and pubic involvement) where we have discussed with the women what they would like to see in the video, when and how they would like to view the video and how they would like the video to help them. We have incorporated all of this information into the script for our virtual reality education film (VREF). The script has been reviewed by multiple health professionals including midwives, obstetricians and anaesthetists to ensure a balanced and accurate view of an eCS is provided. It has also been read by patients prior to their eCS and their feedback has been taken into account for the final version of the script.

We have also discussed how the women feel about the VR element. The VR has been well received, with the main feedback being how useful it will be to be able to 'scroll' around the theatre/wards to fully orientate themselves prior to their eCS.

Step 2: Recruitment to study Potential participants will be identified and given information (patient information leaflet) about the study on an ad hoc basis when booked for their elective LSCS at any point during their pregnancy (as long as it's prior to 38 weeks gestation); this can be done by either their obstetrician or the research midwives.

Approved posters will be on the walls of the antenatal clinic with information about the study and contact details.

Research midwives will then contact the patients by phone to invite them for a formal appointment to consent at 38 weeks. Many patients will be attending hospital at around 38-39 weeks for obstetric follow up, so if feasible, research appointments will be aligned with this. If patients are not attending routinely, we will invite them for an appointment with the research midwives at an alternative time.

Formal consent will be sought at the appointment. Given that this study will only be undertaken for elective procedures, all patients will have plenty of time to weigh up the information provided to them before consenting to research and will be able to withdraw from the study any time.

RCOG states the importance of providing the service user with multiple ways to access information about the trial. Is also advises that any information leaflets should be produced in conjunction with the service user to ensure that they are easy to understand as well as accurate. The women will have access to both.

Step 3: Randomisation and baseline anxiety scores and cortisol levels Randomisation will be performed by a computer on a 1:1 basis to eliminate any bias. Patients that are randomised to the control arm will not have their care disadvantaged in any way. They will receive all the standard antenatal care and normal information that we provide prior to an eCS.

All women who consent to the study will require baseline scores for

• State Trait Anxiety Inventory Scale-5
• Visual Analogue Scale for Anxiety
• Serum Cortisol These will be carried out at the 38-39 week routine appointment at DAU to again reduce any additional trips to the hospital. The two anxiety scales/indexes are well validated having been used extensively in research projects across many populations and there are no ethical concerns regarding these.

A blood sample will need to taken for serum cortisol. The women always have a blood sample taken at this appointment to obtain a valid 'Group& Save' and Full Blood Count prior to surgery so there will be no additional venepuncture. All venepuncture and handling of blood products will be carried out by trained personnel in accordance with the Trust's guidelines and policies. For patients randomised to the intervention arm, they will be shown this video during their visit to DAU (Day Assessment Unit). As per the RCOG framework, the welfare of the woman and baby will take priority over any research, and the patients can stop watching the film at any time if they wish to do so.

After watching the VREF they will be able to ask the midwifery team any questions they might have. They will also be given access so they can watch the VREF on their own devices at home if they wish. The women in the intervention arm will also be provided with all the standard antenatal care and information to ensure they are not disadvantaged in any way.

Step 4: Day of elective caesarean section During the day of the eCS, the health and welfare of the woman and baby will be the absolute priority. We will ensure the women understand that they can withdraw from the study at any time during the day or in the recovery period and that this will not affect their care or treatment in any way.

During the day, there will be three time points at which we ask the patients to complete the following; On admission

• State Trait Anxiety Inventory Scale 5
• Visual Analogue Scale for Anxiety
• Serum Cortisol At skin closure
• State Trait Anxiety Inventory Scale 5
• Visual Analogue Scale for Anxiety
• Serum Cortisol 2 hours post-LSCS
• State Trait Anxiety Inventory Scale 5
• Visual Analogue Scale for Anxiety
• Serum Cortisol
• Patient satisfaction score
• Visual Analogue Scores for pain The serum cortisol level (blood test) will need to be taken at all three time points. Wherever possible this will be coordinated with the need for routine venepuncture/cannulation to reduce unnecessary venepuncture. Again, these samples will be taken by appropriately trained professionals to minimise the risk of repeated attempts.

Further information surrounding the birth such as time of birth, time of anaesthesia and fetal APGAR's will be collected unobtrusively by the anaesthetist to give the woman time to bond with her baby once delivered.

Step 5: Day after elective caesarean section

All women will remain an inpatient for at least 24 hours following a caesarean section so we will not need to women to re-attend hospital to gather any follow up data. The following data will be collected:

• Patient satisfaction score
• State Trait Anxiety Inventory Scale 5
• Visual Analogue Scale for Anxiety
• Visual Analogue Scores for pain
• Analgesia consumption in first 24 hours post-LSCS
• Time to breastfeed post-LSCS
• Time to mobilise post-LSCS This data will only be collected if the woman is happy to answer the questions, and we will ensure it is a convenient time for the mother to answer these questions. Again, keeping the welfare of the mother and baby at the forefront.

The following data will be collected from the patient's notes or anaesthetic chart (a sticker will be attached to the anaesthetic chart for the anaesthetist to complete):

• Time of anaesthesia
• Time of adequate block
• Time of birth
• Time of closing of the skin
• Did the mother have skin-to-skin with baby? What time?
• Fetal 5-minute APGAR
• Any unexpected events

Use of Virtual Reality in research

A brief literature review demonstrates there are at least 890 studies assessing virtual reality and anxiety. Virtual reality has been proven to be safe and accepted across multiple populations, including the paediatric population. A VR video was developed by J-H Ryu et al. for paediatric patients about to undergo an elective operation. The video gives them a tour of the operating suite prior to surgery. They report that it was well accepted by patients and their carers' and also demonstrated a reduction in pre-operative anxiety.

There is more limited use of VR in the obstetric population, but studies do exist. For example, Frey et al used VR during labour to assess its use as an analgesic. They again found VR to be an acceptable intervention and found it reduced both perceived pain and anxiety during labour.

In 'Health and safety implications of virtual reality: a review of empirical evidence' , Sharples and Patel discuss some of the potential health and safety implications. The main area they identify if the potential for nausea if fully immersive headsets are used. In our study, the use of headsets are fully optional, and women can stop using a headset at any time if it was causing any nausea.

Overall, virtual reality is a safe and well accepted intervention across multiple populations. We will carefully monitor for any adverse effects and stop the trial immediately if there were any concerns.

Inclusion/Exclusion Criteria:

Patients undergoing elective lower segment caesarean section (LSCS) at the Royal United Hospital, Bath.

Eligibility

• 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.- Women more likely to have atypical anxiety-related behaviour, restricted to:- Patients with a current severe mental health disorder under the care of the perinatal mental health team- Patients with medical or obstetric co-morbidities requiring pre-determined admission to maternity HDU care

• Congenital structural abnormalities requiring pre-determined admission to NICUPatients where spinal anaesthesia is contra-indicated.- Patients who do not have access to a smart phone/computer

Withdrawal criteria

• Emergency LSCS - those in the following standardised categories of urgency as set out by NICE[23].
• Category 1 - immediate threat to life of woman or fetus
• Category 2 - maternal or fetal compromise which is not immediately life-threatening
• Category 3 - no maternal or fetal compromise but needs early birth
• Women who receive a general anaesthetic.

Information Governance:

As per the RCOG guidelines, patient confidentiality will be maintained at all time. All data will be entered into a Trust based computer that is password protected. Subject names will be kept on a database and will be linked only with a study identification number for this research. There will be no patient identifiers. Only the research team will have access to this computer. Personal data will be stored in a locked office and maintained for 12 months after the completion of the study. Research data generated by the study will be stored for 5 years. Data will be collected and retained in accordance with the Data Protection Act 1998.