Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia
Phase: NA
Conditions: Labour Pain
Sponsor: Chelsea and Westminster NHS Foundation Trust

 
 
Clinical Research Protocol Template Version 1.0  
IRAS: 351150           
  CI: Dr Charles Prior   
 
 
 
 
 
CONFIDENTIAL 
Chelsea and Westminster Hospital NHS Foundation Trust, 2025 
 
 
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Short Title/Acronym:  
Spoken animation for labour epidural (SAFE) 
Ethics Ref: TBC 
Date and Version No: 12/03/25 Version 2 
Title: Evaluation of spoken animation as a tool for imparting information about 
epidural labour analgesia  
 
 
Chief Investigator: 
Charles Prior, Consultant Anaesthetist, Chelsea & Westminster NHS 
Trust, West Middlesex site (charles.prior@nhs.net, 07727031670) 
Investigators:  
Philip Barclay, Consultant Anaesthetist, Chelsea & Westminster NHS 
Trust, West Middlesex site (Philip.barclay@nhs.net, 07947611628) 
Andrii Harha, Anaesthetics ST4, Chelsea & Westminster NHS Trust, West 
Middlesex site (andrii.harha@nhs.net, 07464404338) 
Nayyaamat Sandhu, Anaesthetics ST4, Chelsea & Westminster NHS 
Trust, West Middlesex site (nayyaamat.sandhu1@nhs.net) 
Robert McCutcheon, Associate Professor, Department of Psychiatry, 
University of Oxford (Robert.mccutcheon@psych.ox.ac.uk) 
 
Sponsor:  
Chelsea and Westminster Hospital NHS Foundation Trust 
Damon Foster, Research Operations Manager, Chelsea and Westminster 
damon.foster2@nhs.net     020 3315 6825 
Funder: 
Joint Research Committee  

 
 
Clinical Research Protocol Template Version 1.0  
IRAS: 351150           
  CI: Dr Charles Prior   
 
 
 
 
 
CONFIDENTIAL 
Chelsea and Westminster Hospital NHS Foundation Trust, 2025 
 
 
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Chief Investigator Signature:   
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so.  
 

 
 
Clinical Research Protocol Template Version 1.0  
IRAS: 351150           
  CI: Dr Charles Prior   
 
 
 
 
 
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Chelsea and Westminster Hospital NHS Foundation Trust, 2025 
 
 
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TABLE OF CONTENTS  
1. SYNOPSIS…………………………………………………………………………………………………………………….….4 
2. ABBREVIATIONS…………………………………………………………………………………………………...………..4 
3. BACKGROUND AND RATIONALE…………………………………………………………………………….…..…..5 
4. OBJECTIVES ABD OUTCOME MEASURES/ENDPOINTS……………………………………….…….………5 
5. STUDY DESIGN………………………………………………………………………………………………….……..……..6 
6. PARTICIPANT IDENTIFICATION………………………………………………………………………...……………..7 
6.1 Study participants…………………………………………………………………………….…….…………..7 
6.2 Inclusion criteria…………………………………………………………………………….…….……………..7 
6.3 Exclusion criteria……………………………………………………………………………….………………..7 
7. STUDY PROCEDURES…………………………………………………………………………………..……..…………..7 
7.1 Recruitment………………………………………………………………………………………………………..7 
7.2 Informed Consent……………………………………………………………….………..……………..……..7 
7.3 Potential risks and benefits……………………….………………………………………………………..7 
7.4 Screening and Eligibility Assessment………………………………….…………………….………….8 
7.5 Randomisation/Withdrawal of Participants form Study…………………….……….……….8 
7.6 Baseline Assessments………………………………………….………………………….………….……….8 
7.7 Subsequent Assessment……………………………………………………………….……..….………….8 
7.8 Discontinuation/Withdrawal of Participants from Study………………….………………....8 
7.9 Definition of End of Study……………………………………………………………….…………………..9 
8. INTERVENTIONS……………………………………………………………………………………….……………………..9 
9. STATISTICA AND ANALYSIS……………………………………………………………………….……………………..9 
9.1 Description of Statistical Methods………………………………………………….………….………..9 
9.2 The Number of Participants…………………………………………………………………..………….10 
9.3 Analysis of Outcome measures/Endpoints………………………………………………………..10 
10. DATA MANAGEMENT……………………………………………………………………………………………………10 
10.1 
Access to Data……………………………………………….………………………………………10 
10.2 
Data Recording and Record Keeping……..…………………………….…..……………10 
11 ETHICAL AND REGULATORY CONSIDERATIONS…………………………………………….……………….…..10 
11.1 
Declaration of Helsinki…………………………………………………….………………..…..10 
11.2 
ICH Guidelines for Good Clinical Practice……………………….…………………..….11 
11.3 
Approvals…………………………………………………………………….…………………………11 
11.4 
Reporting………………………….…………………………………………..……………………….11 
11.5 
Participant Confidentiality………………………………………….………………………….11 
12 FINANCE AND INSURANCE……………………………………………………………………….………………………..11 
12.1 
Funding……………………………………………………………………..…………………………..11 
12.2 
Insurance…………………………………………………………………..…………………………..11 
13 PUBLICATION POLICY…………………………………………………………………………….………………….……….11 
14 REFERENCES………………………………………………………………………………………….…………………………..12 
15 AMENDMENT HISTORY………………………………………………………………………….…………………….…….13 

 
 
Clinical Research Protocol Template Version 1.0  
IRAS: 351150           
  CI: Dr Charles Prior   
 
 
 
 
 
CONFIDENTIAL 
Chelsea and Westminster Hospital NHS Foundation Trust, 2025 
 
 
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1. SYNOPSIS 
 
Study Title 
Evaluation of spoken animation as a tool for imparting information about 
epidural labour analgesia  
Short Title/Acronym 
Spoken animation for labour epidural (SALE) 
Study Design 
Prospective, randomised controlled trial with a pre-post design, as well as a 
qualitative analysis of user acceptability  
Study Participants 
Primiparous women presenting for planned induction of labour at The 
Queen Mary Maternity Unit (QMMU), West Middlesex University Hospital  
Planned Sample Size 
60 in control group, 60 in intervention group (120 in total) 
Planned Study Period 
6 months  
 
Objectives 
Endpoints 
Primary 
 
To evaluate the efficacy of a novel 
animated information film designed to 
improve uptake of information 
regarding labour epidural to expectant 
people  
Change in decisional conflict score 
regarding choice of epidural 
analgesia before and after 
exposure to the animated film, as 
well as change in subjective 
anxiety and satisfaction rating.  
 
2. ABBREVIATIONS 
 
CI 
Chief Investigator 
CRF 
Case Report Form 
CWFT 
Chelsea and Westminster Hospital Foundation Trust 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
ICF 
Informed Consent Form 
NHS 
National Health Service 
NRES 
National Research Ethics Service 
PI 
Principal Investigator 
PIS 
Participant/ Patient Information Sheet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 
 
 

 
 
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3. BACKGROUND AND RATIONALE 
 
Informed consent for labour epidural at the time of delivery is often challenging, particularly when 
language and cultural barriers are present. A recent survey of 28 maternity units across Greater London 
revealed that, many women cannot recall being adequately informed prior to receiving an epidural [1]. 
With support from CW+ charity, we recently produced a short, animated film titled “An Introduction to 
Epidural Pain Relief” with the aim of improving basic understanding and enhancing the decision-making 
process regarding labour analgesia.   
Having produced the film, we wish to carry out this research for the following reasons:  
• 
To justify and inform larger scale research on the impact of spoken animation on uptake of 
epidural and other outcomes.  
• 
To potentially support uptake of the film more widely throughout NHS maternity services. 
• 
Evaluate efficacy and user acceptance of the animated film within our Maternity Unit. 
• 
To inform any editing or modification to the film that may be necessary. 
• 
To identify any particular benefits in groups of specific demographic, cultural or ethnic 
characteristics.  
4. OBJECTIVES AND OUTCOME MEASURES/ENDPOINTS 
 
Objectives 
Outcome Measures/Endpoints  
Primary Objective 
 
Primary outcome: change in total Decisional Conflict 
Score (DCS) regarding labour epidural, before and after 
exposure to information material. 
Secondary Objectives 
 
Change in the following DCS subscore categories: 
uncertainty, informed, values clarity, support, effective 
decision.  
Self-reported Likert scale outcomes for understanding of 
the epidural procedure, associated anxiety and overall 
satisfaction with information received.  
Tertiary Objectives 
 
Focussed qualitative interviews involving a smaller 
patient group - to assess acceptability and specific 
feedback for the animated film itself.  
 
 
 

 
 
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5. STUDY DESIGN 
 
Amend as necessary – insert all steps which participants will go through. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* OAA leaflet – validated written information card produced by the Obstetric Anaesthetists’ Association 
** “Introduction to Epidural Pain Relief” animation produced by our group with support from CW+  
Participants provide informed consent 
to participate 
Participants complete baseline survey   
Group 1: (Control) 
Patient reads Obstetric 
Anaesthetists’ Association (OAA) 
epidural information leaflet* only 
All patients complete 
post intervention survey 
Group 2: (Intervention) 
Patient watches “Introduction to 
Epidural” Animation** 
Patient then reads OAA epidural 
information leaflet   
Patients in group 2 offered opportunity 
to participate in focussed interview 
regarding the animated film  
Randomised into one of two groups  
Participants complete their 
participation in the study 
Study information sheet given to 
patients following admission, prior to  
induction of labour  
Patients decline to 
participate 

 
 
Clinical Research Protocol Template Version 1.0  
IRAS: 351150           
  CI: Dr Charles Prior   
 
 
 
 
 
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Chelsea and Westminster Hospital NHS Foundation Trust, 2025 
 
 
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6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
Study participants will be identified from booking records for Induction of Labour on the Queen Mary 
Maternity Unit, West Middlesex Hospital, antenatal ward.  
6.2. Inclusion Criteria 
• 
Primiparous birthing people presenting for induction of labour at QMMU 
6.3. Exclusion Criteria 
The participant may not enter the study if any of the following apply: 
• 
Patient refusal  
• 
Unable to speak English or any of the seven language translations provided 
• 
Epidural contraindicated 
• 
Previous Epidural for any reason 
• 
Any significant health concerns  
7. STUDY PROCEDURES 
7.1. Recruitment 
Potential participants will be identified on the day of admission to the antenatal ward and approached by 
one of the research team, whom will check their eligibility criteria and explain the study, as well as 
providing the PIS, before taking informed consent. 
7.2. Informed Consent 
Participants will personally sign and date the ICF, before any study specific procedures are performed. 
Written and verbal versions of the PIS and ICF will be presented to the participants detailing the exact 
nature of the study and what it will involve for the participant. It will be clearly stated that the 
participant is free to withdraw from the study at any time for any reason without prejudice to future 
care, and with no obligation to give the reason for withdrawal. A copy of the signed ICF will be given to 
the participant, and a copy of the signed ICF will be placed in the patient’s medical notes. The original 
signed form will be retained at the study site in the Investigator Site File. The participant will be allowed 
as long as necessary, but at least prior to commencing induction of labour, to consider the information, 
and the opportunity to ask questions to decide whether they will participate in the study. 
7.3. Potential risks and benefits 
No material risk to patient as standard information is being presented in a new animated format, 
alongside traditional written information.  

 
 
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Those in the intervention group may benefit from clearer and more digestible information regarding the 
fundamental aspects of labour epidural, in an animated format.  
7.4. Screening and Eligibility Assessment 
Participants will be asked the eligibility questions prior to obtaining informed consent and complete a 
checklist for each participant, which will be attached to the consent form in the study folder. 
7.5. Randomisation, blinding and code-breaking 
Randomisation to the intervention or control group will be carried out with block randomisation using a 
sealed envelope method. Randomisation will be stratified by ethnicity to ensure an even distribution of 
ethnic groups.  
7.6. Baseline Assessments 
Participants will be asked to: 
1.  Complete the pre-intervention survey  
7.7. Subsequent Assessment 
2.  Watch animation (intervention group only)  
3.  Read OAA information card 
4.  Complete post-intervention survey  
5.  If in intervention group, to be offered the opportunity to participate in short, structured 
interview about the animation (depending on timing of induction of labour)  
7.8. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the Investigator may 
discontinue a participant from the study at any time if the Investigator considers it necessary for any 
reason including: 
• 
Ineligibility (either arising during the study or retrospectively having been overlooked at screening) 
• 
Significant non-compliance with study requirements  
• 
Withdrawal of consent 
• 
Expedition of induction of labour not allowing enough time for participation in study 
• 
Any significant change in clinical circumstances preceding induction of labour that interrupt the 
study process or may cause distress to the participant, as judged by the Investigators.  
 
If a participant withdraws from the study, data already collected with consent will be retained and used 
in the study. But no further data will be collected or any other research procedures carried out on or in 
relation to the participant. The reason for withdrawal will be recorded in the CRF. 

 
 
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  CI: Dr Charles Prior   
 
 
 
 
 
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7.9. Definition of End of Study 
The end of the study will be when the planned number of participants have been recruited and data 
collected.  
8. INTERVENTIONS  
 
The intervention in this study involves the provision of information regarding labour analgesia options, 
specifically epidural, prior to induction of labour.  
Control group: Information provided in the form of the gold standard, validated OAA written information 
card. 
Intervention group: Information provided in the form of novel CW+ “Introduction to epidural pain relief” 
animation, followed by the OAA written information card.  
9. STATISTICS AND ANALYSIS 
 
9.1 Description of Statistical Methods 
The primary analysis population will include all eligible participants for whom data is available. 
Participants will be analysed according to their randomised group assignment irrespective of the 
intervention they actually received. Every effort will be made to follow up all participants in both arms 
for research assessments. All type 1 error rates will be fixed at two-sided 5% level. There are no planned 
interim analyses. 
Analyses will be conducted in Stata, and/or R, and/or Python. Descriptive statistics within each 
randomised group will be presented for baseline DCS score values. These will include counts and 
percentages for binary and categorical variables, and means and standard deviations, or medians with 
lower and upper quartiles, for continuous variables, along with minimum and maximum values and 
counts of missing values. There will be no tests of statistical significance or confidence intervals for 
differences between randomised groups on any baseline variable. 
Pre- and post- test Likert scale data for perceived understanding, anxiety and satisfaction will be 
visualised using histograms. 
Primary and secondary endpoints in treatment period: 
Treatment effects on primary and secondary outcomes will be estimated using generalised linear mixed 
models. Fixed effects will be baseline assessment for the outcome under investigation, randomisation, 
timepoint (pre- or post- intervention), and timepoint*randomisation group interactions.  Participants will 
be included as random intercepts. Marginal treatment effects will be estimated for outcomes at each 
time point, and reported separately as adjusted mean differences in scores between the groups with 
95% confidence intervals and 2-sided p-values. 
The primary outcome is the change in DCS score from pre- to post- intervention, and the difference 
between the two groups will be estimated from a linear mixed model as described above. For all 

 
 
Clinical Research Protocol Template Version 1.0  
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  CI: Dr Charles Prior   
 
 
 
 
 
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continuous secondary outcomes in the treatment period (DCS sub-scores), the same analysis will be 
employed. The random effect structure of the main analysis will account for repeated measures. Missing 
data on individual measures will be pro-rated if more than 80-90% of the items are completed; otherwise 
the measure will be considered as missing. 
As soon as the last patient visit has been completed, data will be cleaned and locked. 
  
9.2  Sample Size Determination 
Assuming a baseline-endpoint correlation of 0.5 and two-sided type 1 error rate of 0.05, to detect a 
standardised between group effect size of 0.51 with 80% power requires 60 participants per group (120 
in total). 
 For structured interviews regarding animation content and acceptability, we will aim for 20 participants.  
 
9.3 Analysis Populations 
For the primary and secondary analyses, the population will include all eligible participants for whom 
data is available. Participants will be analysed according to their randomised group assignment 
irrespective of the intervention they actually received. 
 
10. DATA MANAGEMENT 
10.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor or host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. The study may be 
monitored, or audited in accordance with the current approved protocol, ICH GCP, relevant regulations 
and standard operating procedures. 
10.2. 
Data Recording and Record Keeping 
Data will be stored on secure computers at the Queen Mary Maternity Unit, Chelsea & Westminster NHS 
Trust.  
 
11. ETHICAL AND REGULATORY CONSIDERATIONS 
11.1. 
Declaration of Helsinki 

 
 
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The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
11.2. 
ICH Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in full conformity with relevant regulations and 
with the ICH Guidelines for Good Clinical Practice. 
11.3. 
Approvals 
All relevant documentation will be submitted to the NHS Research Ethics Committee (REC), and host 
institution R&D departments. The Investigator will submit and, where necessary, obtain approval from 
the above parties for all substantial amendments to the original approved documents. 
11.4. 
Reporting 
An End of Study notification and final report will be submitted to the same parties. Study will be 
registered to clinicaltrials.gov.  
11.5. 
Participant Confidentiality 
The acquired data will be stored on a computer that is password protected. Data will be held in the NHS 
database of the host institution. Data will be kept for 3 years. 
All paperwork will be stored in a locked clinical office within the Department of Anaesthesia of the host 
institution. 
A unique patient/volunteer identification number will be used to prevent identification of subjects involved 
in the study. 
12. FINANCE AND INSURANCE 
12.1. 
Funding 
Joint Research Committee, Chelsea & Westminster Hospital NHS Foundation Trust. 
12.2. 
Insurance 
Chelsea and Westminster Hospital NHS Foundation Trust has appropriate indemnity arrangements in 
place. 
13. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authorship will be determined in accordance with the 
ICMJE guidelines and other contributors will be acknowledged. 
 
 

 
 
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14. REFERENCES 
 
1. 
Brinkler R, Edwards Z, Abid S, Oliver C, Lo Q, Stewart A, et al. A survey of antenatal and 
peripartum provision of information on analgesia and anaesthesia. Anaesthesia. 2019;74(9):1101-11. 
 
2. 
Eley VA, Donovan K, Walters E, Brijball R, Eley DS. The effect of antenatal anaesthetic 
consultation on maternal decision-making, anxiety level and risk perception in obese pregnant women. 
International Journal of Obstetric Anesthesia. 2014;23(2):118-24. 
3.  
Kohn MA, Senyak J. Sample Size Calculators [website]. UCSF CTSI. 28 September 2024. Available 
at https://www.sample-size.net/ [Accessed 30 September 2024] 
 
 
 
 

 
 
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  CI: Dr Charles Prior   
 
 
 
 
 
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15. AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made