Virtual Reality in Elective Caesarean Births Study (VREC)- A Feasibility Study for a Virtual-reality Based Tool to Improve Patient Reported Outcomes Following Elective Caesarean Section.
Phase: NA
Conditions: Anxiety, Pregnancy, Pain
Sponsor: Royal United Hospitals Bath NHS Foundation Trust

VREC Study Protocol (Version 4) 13/03/2024 
Version 4 Date of publication: 13 March 2024 | IRAS 23/ES/0025 
© Royal United Hospitals Bath NHS Foundation Trust 
 
 
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Title: Virtual Reality in Elective Caesarean sections  - VREC 
 
A prospective randomised exploratory study to determine the impact of a pre-
operative virtual reality film on anxiety-related outcomes in women undergoing 
elective caesarean section. 
 
 
Sponsor 
Royal United Hospitals Bath NHS FT 
 
Funder 
Research Capability Fund 
 
Funder Ref: 
N/A 
REC Reference 
23/ED/0025 
IRAS number 
291646 
 
Protocol authorised by: 
 
Dr Kelly Spencer Head of Research Operations   …………………………………….  
 
Date  
 

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Key Study Contacts  
 
Chief Investigator 
Dr Rebecca Leslie 
Consultant Anaesthetist 
Department of Anaesthesia, Royal United Hospital 
Bath NHS FT 
Key collaborators  
Dr 
Rachel 
Beer, 
Anaesthetic 
Clinical 
Fellow 
Department of Anaesthesia, Royal United Hospital 
Bath NHS 
Rachel.beer@nhs.net 
 
Dr 
Hannah 
Swinburn, 
Anaesthetic 
Registrar, 
Department of Anaesthesia, Royal United Hospital 
Bath NHS  
Hannah.swinburne@nhs.net 
 
Dr Mark Gosling, Anaesthetic Clinical Fellow, 
Department of Anaesthesia, Royal United Hospital 
Bath NHS 
Mark.gosling@nhs.net 
 
Dr Lowri Bowen,  Anaesthetic Core Trainee,  
Department of Anaesthesia, Royal United Hospital 
Bath NHS 
Lowri.bowen1@nhs.net 
 
Research Team Lead 
Sara Burnard, Lead Research Midwife 
Royal United Hospitals Bath NHS FT 
Sara.burnard@nhs.net  
Sponsor Lead 
Jane Carter, Head of Research Development,  
Royal United Hospitals Bath NHS FT 
Jane.Carter@nhs.net 
 
Dr Kelly Spencer, Head of Research Operations, Royal 
United Hospitals Bath NHS FT 
Kelly.Spencer@nhs.net 
 
 
 
 

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Table of contents 
 
Table of contents 
Abbreviations 
1    Study Summary 
3 
4 
5 
2    Study Rationale 
5 
3    Study Aims and Objectives 
7 
      3.1   Primary Research Aim 
      3.2   Primary hypothesis                                                                    
7 
7 
      3.3   Null hypothesis    
      3.4   Secondary Research Aim 
7 
7 
      3.5   Study Outcome Measures 
7 
      3.6   Study Population and Eligibility 
8 
      3.7   Project Duration 
9 
4    Study Design 
10 
      4.1   Study Outline 
10 
5    Recruitment Process 
11 
      5.1   Recruitment 
      5.2   Consent 
11 
12 
6    Risks to patients 
12 
7    Data  
13 
      7.1   Patient Randomisation 
      7.2   Data Collection and Storage  
13 
13 
8    Patient Follow Up 
      8.1   Pre-operative Demographic Data 
      8.2   Data Collection Timings & details 
13 
13 
14 
9    Study Analysis   
15 
      9.1   Sample Size Calculation 
15 
      9.2   Statistical Analysis 
15 
10  Data Storage 
11  Study Sponsorship and Management 
16 
16 
12  Publication Policy and Dissemination to Participants 
17 
13  Disclosures 
17 
15 References 
17 
 
 
 
 
 

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Abbreviations 
 
 
NHS FT 
National Health Service Foundation Trust 
BBC 
Bath Birthing Centre 
CS 
Caesarean section  
LSCS 
Lower segment caesarean section 
T1, T2 etc 
Time points 1, 2 etc 
RUH 
Royal United Hospitals Bath 
VR 
Virtual reality 
VREC 
Virtual Reality in elective caesarean 
section  
VREF 
Virtual reality educational film  
APGAR 
Score that measures 5 variables each 
scored on a scale of 0 to 2 with 2 being 
the best score.  Total score out of 10.  
 
Appearance (skin colour) 
Pulse (heart rate) 
Grimace (reflexes 
Activity (muscle tone) 
Respiration (breathing rate and effort) 
STAI-5 
State Trait Anxiety Inventory Scale 5 
VAS-A 
Visual analogue scale for anxiety 
VAS-P 
Visual analogue scale for pain 
NICE 
National Institute for Health and Care 
Excellence 
NICU 
Neonatal intensive care unit 
HDU 
High dependency unit 
QDS 
Four times a day 
TDS 
Three times a day 
mg 
milligrams 
IM 
Intramuscular 

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1. 
Study Summary 
 
Study Title 
Virtual Reality in Elective Caesarean Sections 
Short title 
VREC 
Study Design 
Prospective randomised feasibility study 
Study Participants 
Pregnant women  
Planned Sample Size 
40 (20 intervention group and 20 control group) 
Treatment Duration 
No longer than four weeks 
Follow up duration  
From decision for elective CS by 38 weeks gestation to 24 hours 
post-LSCS.  Planned duration no longer than four weeks 
Planned study period 
Five months (November 2023 – March 2024) 
Primary 
From pre-assessment at approximately 38-39 weeks gestation to 
two hours post-LSCS 
Secondary 
From 2 hours post-LSCS to 24 hours post-LSCS 
Intervention 
Access to a virtual reality video demonstrating the patient 
pathway for elective section to be watched prior to surgery.  
Intervention Protocol 
Participants randomised to the intervention group will be given 
unlimited access to a VR educational film demonstrating the 
patient pathway for elective caesarean section at 38 weeks. 
Anxiety will then be assessed using state trait anxiety inventory 
scale 5, visual anxiety scale and cortisol levels and compared 
between the intervention and control group at four time points. 
Funder 
 
Research Capability Funding 
 
 
2   
Study Rationale  
  
At the Royal United Hospitals Bath (RUH), approximately 4500 deliveries occur every 
year of which approximately 10% (450) of these deliveries are performed as elective 
caesarean sections (CS).   
 
Anxiety is considered to be an emotional response to a perceived threat or danger 
[1].  More specifically peri-operative anxiety is the subjective feeling of apprehension 
and fear associated with impending procedures, such as anaesthesia or surgery.  
Whilst a CS is seen as a routine procedure, Wyatt et al. reported high pre-operative 
anxiety in women prior to their CS [2].  Studies have demonstrated that in mothers-
to-be undergoing CS their subjective anxiety is highest before CS and significantly 
declines at skin closure after the baby was born [3,4]. 
 
Although anxiety is defined as a psychological insult which may result in avoidance of 
healthcare services and a lack of trust or confidence in healthcare professionals, the 
physiological sequelae also confer significant morbidity in the peri-operative period. 

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These include increased pain perception and thus analgesic requirements, delayed 
wound healing due to raised cortisol and blood glucose, prolonged recovery and 
length of hospital stay, and increased risk of infection.  [5-10]. In addition, in obstetric 
patients specifically high anxiety levels before a CS are linked to slower recovery from 
the surgery, higher postoperative pain levels and reduced patient satisfaction [11,12].   
 
The importance of providing high-quality pre-operative information to help patients 
reduce their anxiety is well reported [13-16].  More recently novel ways of delivering 
pre-operative information has been investigated.  A recent study found that showing 
paediatric patients a virtual reality tour of the operating theatre before anaesthesia 
reduced pre-operative anxiety by 30% and increased compliance during induction of 
anaesthesia in children [17].  Another study again, demonstrated lower anxiety levels 
in children who had been shown a preoperative virtual reality exposure tour 
compared to the control group [18].   
 
Historically VR has been used clinically most frequently for the treatment of phobias, 
as it allows patients exposure to fearful situations in a safer, less embarrassing and 
cost-effective way.  It has also been found that patients acceptance of the use of VR is 
high [19].   
 
A study performed by Schaal et al compared anxiety levels on the day of CS in women 
receiving their first CS compared to those who had already had one.  They found that 
women receiving their first CS were more anxious than women who had already 
experienced one [4].  This is thought to because the mother-to-be is aware of what 
will happen during the procedure.  This is in line with other research, which shows 
that having experienced a specific operation or anaesthesia before has a very positive 
effect on the psychological state of the patient when they undergo the same 
procedure again [20-22].  This evidence lends weight to the idea that an intervention 
such as a virtual reality film allowing mothers-to-be to ‘virtually’ experience having a 
CS should have a soothing effect on pre-operative anxiety and thereby improve 
postoperative pain and maternal satisfaction [12]. 
 
Whilst new research is emerging for the use of VR for pre-operative education in 
paediatric patients there is currently no evidence to show if it is of benefit for 
obstetric patients.  For a mother, the day of their babies birth is one of the most 
important and memorable days of their lives and everything should be done to 
minimise anxiety and stress for these women.  Therefore, in this study we will 
consider the effect of a VR educational film on peri-operative anxiety in patients 
undergoing an elective CS.   
 
 
 
 
 
 

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3    Study Aims and Objectives 
 
3.1  Primary Research Aim 
 
The overarching aim of this prospective study is to establish if we can produce a 
virtual reality education film which is acceptable for women undergoing elective 
caesarean section. 
 
3.2   Primary Hypothesis 
 
Can we produce an informative virtual reality film which is acceptable to women 
undergoing elective caesarean section. 
 
3.3   Null Hypothesis 
 
The null hypothesis is that we produce a virtual reality education film which is 
acceptable to our obstetric patients. 
 
3.4   Secondary aims 
 
Our secondary aim is to investigate if pre-operative preparation with a virtual reality 
film can alter the course of anxiety in women undergoing elective caesarean section. 
 
In addition, research suggests that perioperative anxiety has a negative affect on 
patient’s pain post operatively.  Therefore, we intend to look at patient’s pain scores 
and analgesic requirements.   
 
We will also collect data on patient satisfaction scores.   
 
Furthermore, we intend to collect data on how quickly patients fed their baby post-
delivery, how quickly they mobilise and what the babies APGAR score is at the time of 
delivery. 
 
3.5   Study Outcome Measures 
 
Primary outcome measures: 
 
• Patient feedback questionnaire after watching virtual reality education film. 
 
 
 
 

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Secondary outcome measures: 
 
• State Trait Anxiety Inventory Scale 5 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) (Score 20-80). 
 
• Visual Analogue Scale for 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 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) (Units). 
 
• Patient satisfaction 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) 
 
• Visual Analogue Scores (VAS) for pain at two time points (T4 at 2 hours post-
LSCS, T5 at 24 hours post-LSCS patient will be phoned if they have left the 
hospital) (Score 0 to 10)  
 
• Analgesia consumption in first 24 hours post-LSCS (amount of morphine in 
mg) 
 
• Time to feed baby post-LSCS (breast or bottle) (minutes) 
 
• Time to mobilise post-LSCS (minutes) 
 
• Fetal 5-minute APGAR  
 
 
3.6  Study Population and Eligibility 
 
The study population are patients over the age of 18 who are undergoing their first 
elective lower segment caesarean section (LSCS) at the Royal United Hospitals, Bath.  
 
Inclusion criteria: 
 
To be eligible to participate in the study participants must: 
 
• Have had the decision for elective LSCS by 38 weeks gestation. 
• Has never had an emergency or elective section previously  

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• 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 
 
Withdrawal criteria: 
 
• Emergency LSCS -  those in the following standardised categories of urgency 
as set out by NICE[23]. 
o Category 1 – immediate threat to life of woman or fetus 
o Category 2 – maternal or fetal compromise which is not immediately 
life-threatening 
o Category 3 – no maternal or fetal compromise but needs early birth 
• Women who receive a general anaesthetic. 
 
3.7   Project Duration 
 
The overall study period will be approximately 6 weeks.  The patient will only be in the 
study at the point of recruitment and then for a maximum of 24 hours after the 
participant has delivered her baby by elective lower segment caesarean section. 
 
 
 
 
 
 

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4   
Study Design 
 
4.1   Study Outline 
 
This is a prospective, randomised, single-centred exploratory study with two groups, 
the intervention group and the control group.  Women will be recruited from the 
Royal United Hospital NHS Foundation Trust.  
 
The Intervention 
 
A virtual reality educational film (VREF) will be produced.  The film will be scripted, 
and the following specialists will have input on the content and structure of the film: 
 
1. Patients who have either recently had an elective CS or who are waiting to 
have an elective CS. 
2. Midwives 
3. Anaesthetists 
4. Obstetricians 
 
The film will be 15 minutes long and will be shot by an external professional film 
company on site at the RUH birthing centre using real locations (including the pre-
operative assessment clinic, the birthing centre, the operating theatre, recovery and 
the post-natal ward).   
 
Prior to use in this study the film will be reviewed by: 
 
1. Patients who have either recently had an elective CS or who are waiting to 
have an elective CS. 
2. Midwives including the research midwifery team and the Director of 
Midwifery 
3. Anaesthetists 
4. Obstetricians 
5. Maternity Voices Partnership Lead 
6. RUH Head of Communications 
 
Intervention Group  
 
Women recruited to the intervention group of the study will be emailed or texted a 
link to be able to watch the VREF.  The VREF will provide a 360 degree, 3-dimensional 
virtual tour.  It will show what will happen on the day of delivery; from entering the 
Bath Birthing Centre (BBC) through to being on the postnatal ward with their new 
baby.  They will be able to watch this as many times as they would like prior to having 
their CS.  They will be given the contact details of the research midwife to contact if 
they have any questions after watching the film. If there is a clinical question, this is 

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the escalation process which will be followed; research midwives to take details and 
forward on to Dr Rebecca Leslie (by email) who will reply to patient directly over 
phone. Dr Leslie will liaises with obstetric clinical team prior to speaking to patient if 
felt necessary.  
 
Control Group 
 
The control group will be given the routine pre-operative information by the 
midwives and standard written information leaflets, along with the contact details of 
the research midwife if they require any further information.  
 
Day of Delivery 
 
On the day patients are admitted to the BBC for their elective LSCS all patients in the 
VREC trial will receive the same care and will have the same data collected as per the 
data schedule. 
 
Anaesthesia 
 
All patients in this study will receive a spinal anaesthetic for their elective LSCS.  The 
amount of intrathecal local anaesthetic and opiate used will be at the discretion of 
the anaesthetist.   
 
Post-operative medication 
 
All patients will be prescribed regular paracetamol 1g qds and ibuprofen 400mg tds 
for post-operative pain management.  Dihydrocodeine 30mg qds and Oramorph 
10mg every 2 hours will be prescribed as required.  Ondansetron 4mg and 
prochlorperazine 12.5mg IM will be prescribed for nausea.  Naloxone 50mcg 
subcutaneously and chlorpheniramine 4mg orally will be prescribed for post-
operative itching. 
 
5   
Recruitment and Consent 
 
5.1  
Recruitment  
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 all eligible patients 
by phone to invite them for a formal appointment to consent at 38 weeks. Many 

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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.   
 
5.2   Consent 
 
Women will have received information about the study from either the obstetrician 
or the research midwives on an ad hoc basis when booked for an elective LSCS at any 
point of their pregnancy up to 38 weeks gestation.  (Women will be invited to join the 
study, if the decision is made for a caesarean section, prior to 38 weeks).  They will be 
given at least 24 hours between approach and consent being sort in which to consider 
whether or not they would like to take part. A member of the research team will 
phone all patients who received the information to see if they are happy to 
participate.  They will then be invited to attend an appointment with the research 
midwives, this will be combined with their obstetric follow up appointment if able. At 
this appointment, formal consent will be sought in person. All members of the 
research team are experienced at recruiting participants and are Informed Consent or 
Good Clinical Practice trained.  
 
Patients will be given contact details of the study team (research midwives) should 
they have any questions between consent and their LSCS.  They will be able to 
withdraw consent at any time, before or after their LSCS. 
 
6   
Risks  
 
There are very few risks to patients involved in this study.  If the participants have any 
concerns after watching the VREF, they will be given a number to call to discuss with a 
member of the research midwifery team. 
 
High anxiety levels are associated with significant morbidity including increased pain 
perception (with higher analgesic requirement), increased length of hospital stay and 
a higher risk of post-operative wound infection (5-10). If patients are found to have a 
high STAI-5 or VAS, this will trigger a brief psychological assessment by the research 
team which will exclude acute suicidal ideation or psychosis and a referral to the 
perinatal mental health team will be completed if required (with patient consent, 
unless there are concerns regarding capacity). There is an existing mental health 
screening tool with a scoring system on the hospital computer system which will be 
used and patients referred on as required. 
 
No risks to researchers have been identified. 
 
 
 

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7   
Data  
 
7.1  
Patient Randomisation 
 
Patients will be block randomised 1:1 in blocks of 10 between standard pre-operative 
education and the use of a virtual reality film.  Randomisation will occur by random 
number generation by the research midwife with a coded master list after consent 
has been obtained.  
 
7.2   Data Collection and Storage 
 
All data will be entered into a secure 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 direct patient 
identifiers kept on the main database. Only the direct research team will have access 
to this computer.  Data will be stored in a locked office and maintained for a 
minimum of five years after the completion of the study. 
 
8   
Patient Follow Up 
  
8.1   Data Collection Required 
 
The following data will be recorded for all patients enrolled in the study. 
 
Pre-operative Demographic data 
 
• Date decision for a category 4 LSCS was made. 
• Gestation at the above ‘decision’ date. 
• Gravity 
• Parity 
• Were any unexpected changes made to the date of the LSCS? 
 
8.2   Data Collection timings 
 
T1:  Consent appointment with research midwives (approx. 38-39 weeks 
gestation) 
• State Trait Anxiety Inventory Scale 5 
• Visual Analogue Scale for Anxiety 
• Serum Cortisol 
 

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Day of LSCS: 
 
T2:  On admission (all performed by research midwives unless out of hours and on 
call anaesthetist will do) 
• State Trait Anxiety Inventory Scale 5 
• Visual Analogue Scale for Anxiety 
• Serum Cortisol 
 
T3:  At skin closure (all performed by research midwives unless out of hours and 
on call anaesthetist will do) 
• State Trait Anxiety Inventory Scale 5 
• Visual Analogue Scale for Anxiety 
• Serum Cortisol 
 
Post-operatively: 
 
T4: 2 hours post-LSCS (all performed by research midwives unless out of hours 
and on call anaesthetist will do) 
• State Trait Anxiety Inventory Scale 5 
• Visual Analogue Scale for Anxiety 
• Serum Cortisol 
• Patient satisfaction score 
• Visual Analogue Scores for pain  
 
 
T5:  24 hours post-LSCS (all performed by research midwives unless out of hours 
and on call anaesthetist will do) 
• 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 
 
The following information will be collected from the patient’s notes/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 

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• Did the mother have skin-to-skin with baby? What time? 
• Fetal 5-minute APGAR 
• Any unexpected events 
 
 
Data Collection Details 
 
State Trait Anxiety Inventory Scale 5 – this is a scoring system for anxiety consisting of 
a 5-item self-completed questionnaire (24).  There are a choice of four answers 
ranging from ‘not at all’ to ‘very much so’. We expect this to take 2 minutes to 
complete.  
 
Visual Analogue Scale for Anxiety (VAS–A) – this is also a scoring system for anxiety.  It 
is one question with a Likert scale of 0-10. We expect this to take 1 minute to 
complete. 
 
Serum Cortisol- this is a hormone and requires a blood test to be measured.  There 
are four points at which this will occur.   The first three will coincide with routine 
blood tests that are required during routine antenatal care. The fourth is 2 hours after 
delivery and this can be done in recovery, when the spinal anaesthetic is still working. 
 
Patient satisfaction score – It is one question with a likert scale of 0-10. We expect 
this to take 1 minute to complete. 
 
Visual Analogue Scores for pain (VAS-P) - this is a scoring system for pain. It is one 
question with a likert scale of 0-10. We expect this to take 1 minute to complete. 
 
9   
Study Analysis  
 
9.1    Sample size 
 
We have included a target sample size of 40 patients. This is an exploratory study and 
as such, precise effect-sizes are not known. 
 
9.2   Statistical analysis 
 
Demographic data will be tabulated to demonstrate any differences between the two 
groups, which have occurred by chance.  This will include the date the LSCS was 
made, age of mother, gestation, gravity, pariety and if there were any unexpected 
changes made to the date of the LSCS.  This is to ensure there are no large 
discrepancies between the groups which may influence their anxiety scores. The 
items in this table will not be tested statistically.   
 

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Ordinal data will be collected from the Likert scales used in the STAI-5, VAS-A, VAP-P 
and satisfactory score. The main outcome of area under curve for these, as well as 
the cortisol levels will be calculated using the trapezium rule and examined for 
normality using histograms. 
 
Normally distributed differences between the two groups will be tested using an 
independent sample 2 tailed t-test and illustrated using mean difference and 
confidence interval.  If not normally distributed the difference between the groups 
will be tested using a Mann-Whitney U test and differences demonstrated using 
medians, interquartile ranges and box plots.   
 
Fisher’s exact test and chi-squared tests will be used for analysis of categorical data.   
 
 
 
10   Data Storage 
 
Data will be collected and retained in accordance with the Data Protection Act 2018 
and General Data Protection Regulation (GDPR). 
 
Study documents (paper and electronic) will be retained in a secure location during 
and after the trial has finished. All source documents will be retained for a period of 
five years following the data collection. Where trial related information is 
documented in the medical records – those records will be identified by a ‘Do not 
destroy before dd/mm/yyyy’ label where date is five years after the last patient last 
visit. 
 
 
11   Study Sponsorship and Management 
 
The sponsor for this study is the Royal United Hospitals Bath NHS Foundation Trust. 
The trial will comply with the Data Protection Legislation including GDPR and will 
comply with all relevant local policies and procedures.  
 
Participants have been and will continue to be involved at each stage of this trial 
including design, trial documents (e.g. consent forms, information sheets), conduct, 
analysis and reporting.  
 
The Research & Development office at the RUH is highly familiar with research studies 
like this and will ensure appropriate governance procedures are met and audit a 
percentage of Trust sponsored projects per year as part of their Research Governance 
responsibilities.  
 
 
 

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12   Publication Policy and Dissemination to Participants 
 
The results of the study will be disseminated to participants if they have chosen to 
receive them when they are asked during the consent procedure. 
  
The study results will be submitted to national and international journals and 
conferences for presentation and publication. 
 
13   Disclosures  
 
No conflicts of interest have been identified.  
 
14   References 
 
1. Speilberger CD Gorsuch RL, Lushene RE, Vagg P & Jacobs G. 1983.  State-trait 
Anxiety Inventory (STAI).  Mind garden, Menlo Park, CA. 
2. Wyatt S, Jones D, Peach M et al.  Anxiety in patients having a caesarean 
section under regional anaesthesia: a questionnaire and pilot study.  Int J 
Obstet Anesth. 2001; 10: 278-283. 
3. Hepp P, Hagenbeck C, Burghardt B et al.  Measuring the course of anxiety in 
women giving birth by caesarean section: a prospective study.  BMC 
Pregnancy Childbirth.  2016;  16:113-120. 
4. Schaal NK,  Fehm T, Wolf OT et al. Comparing the course of anxiety in women 
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