PIVOT: Patient Information Videos on Operations Trial. Patient Information Delivery for the Elective Preoperative Patient; A Single Blinded Randomised Controlled Trial
Phase: NA
Conditions: Patient Education
Sponsor: Royal Devon and Exeter NHS Foundation Trust

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PROTOCOL FOR PIVOT PILOT STUDY: 
PATIENT INFORMATION VIDEOS ON OPERATIONS TRIAL
SUMMARY
Patient education is an important part of preparing patients for surgical procedures. This 
pilot project aims to determine the use of two educational videos created by specialists for 
patients due to have either an elective caesarean section or a trans-vaginal tape / trans-
obturator tape. This pilot study aims to gather the information required to undertake a 
larger scale study which will  assess whether there is a relationship between preoperative 
anxiety levels and education on the procedure when the educational video is used as an 
information giving tool alongside existing resources. A total of 120 patients will be enrolled 
(60  per  group)  and  randomised  to  either  watch  the  video  or  not  watch  the  video. 
Assessment will be done by means of a questionnaire, and results will be collected over 
the  course  of  eight  months.  It  is  expected  that  the  video  may  reduce  anxiety  in 
preoperative patients and that they may feel better informed about the reason for the 
operation, the procedure and the post-operative period. 
RESEARCH QUESTION
Does the additional use of multimedia provide a more effective means of educating the 
patient on risks and benefits of a common elective surgical procedure as well as reduce 
overall pre-operative anxiety?
RATIONALE & BACKGROUND INCLUDING LITERATURE REVIEW
While patients are always explained the key risks and complications of any elective 
surgical  intervention,  they  often  feel  unprepared  for  both  the  hospital  stay  and  the 
postoperative period.1,2 Multimedia has already been used in randomised trials as a means 
of delivering information to patients preoperatively to reduce overall anxiety regarding the
procedure.2,3,4
Currently  in  the  NHS  patient  information  regarding  surgical  procedures  is  delivered 
through tools such as leaflets in combination with consultations where the patient is able to 
ask questions. A video is a concise learning tool which the patient would be able to access 
24/7 and also show their relatives. This would not only allow them enough time to think 
through the possible complications but also to inform them of accurate and up to date 
information which is included in the consent forms they are presented pre-operatively. 
A learning needs assessment where patients were approached post-operatively in Royal 
Devon  and  Exeter  Trust,  Wonford  Hospital  and  asked  to  complete  a  questionnaire 
regarding pre-operative knowledge and anxiety highlighted certain points which patients 
felt they would have liked to have been informed of sooner. For example patients who had 
undergone a C-section commented that side effects of the anaesthetic were not fully 
explained and therefore not expected, and this was subsequently included in the video for 
this patient group. Other comments from the TVT/TOT post-operative patients involved a 
request for a detailed explanation of urinary incontinence and treatment options, including 
recovery time. Every effort was made to include the feedback from patients as points to 
cover in the educational videos created.
This study aims to highlight the benefit of provision of a cheap and accurate information 
tool in the form of a video designed to complement existing methods of preparing patients 
for elective surgical admissions. The ultimate goal is to prepare a database of a selection 
of videos accessible to  patients in their own home at any time. The videos will be 

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monitored and updated, and any videos submitted to the website will be assessed by two 
specialist consultants for accuracy prior to being added to the database.
AIMS AND OBJECTIVES
Aim: Determine whether educational videos are of use as an additional learning resource 
for pre-operative patients. 
Objectives: 
1- Quantify the change between baseline patient anxiety and operative knowledge at 
preoperative assessment, compared to immediately pre-operatively in intervention and 
control group.
2- Record the relative change in anxiety level of pre-operative consented patients who 
have seen the video to those who have not using a ten point visual analogue scale and the 
State Trait Anxiety Inventory.
3- Record the relative change in knowledge base of pre-operative consented patients who 
have seen the video to those who have not. Specifically these headings will be assessed:
–
The condition
–
The operation
–
The risks and complications
–
The post-operative period
Secondary Objectives:
1- Receive verbal and written feedback on the videos in order to improve them
2- Test data collection methods, especially questionnaires.
3- Assess recruitment rate
4- Test the delivery of the video
5- Get an estimate of standard deviation of the outcome measures.
6- Get an estimate of required resources for a full randomised control study.
PLAN OF INVESTIGATION
General research design: A pilot randomised controlled study
Randomisation will be secured through the use of opaque envelopes for allocation to study 
arm. Block randomisation of 10 participants will be used  in order to keep the sizes of 
treatment groups similar. The co-investigator will organise the blocks of envelopes and 
distribute these to the sub-investigators. 
The questionnaires for knowledge will contain a linear scale representing two extremes 
with patients deciding where they lie on the scale by choosing a numerical value, and the 
answers will be allocated to a point scoring system for quantitative analysis.
The assessor will be blinded to the allocation during data input.
The study analysis will be performed by a member of the team who will be blinded to 
patient allocation.
Study Population
Target population: Stage 1 (baseline anxiety and knowledge): Preoperative assessment 
patients who have been consented for the study. Stage 2: Pre-operative patients who have 
been consented for their operation and for the study, in the Royal Devon and Exeter Trust, 
Wonford Hospital
Operations: Elective Caesarean Section, Trans-Vaginal/Trans-Obturator Tape

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Age range: Minimum 18 years of age. No maximum age
Ethnicity: Any
Inclusion criteria:
–
Patients  due  to  have  one  of  the  following  operations:  Elective  Caesarean 
Section, Trans-Vaginal / Trans-Obturator Tape
–
Patients must be consented for the operation before participating in stage 2 of 
the study.
–
English speaking
Exclusion criteria:
–
Any  conditions  which  may  affect  capacity:  eg  dementia,  previous  CVE  or 
reduced cognitive ability
Mechanism of Selection and Recruitment:
Eligible patients will be approached by their clinician or nurse within the direct care team 
during consultation and the project will be explained to them. Verbal consent will be 
obtained to provide the patient with a Patient Information Sheet (see appendices)
Three  weeks  before  the  operation,  either  a  research  nurse  or research  midwife  will 
telephone the patient and obtain verbal consent for participation in the study, explaining 
the project and answering any questions. This will be recorded in the notes. If consent is 
not obtained, it will be recorded in the notes that the project was explained and the patient 
is not willing to take part. If consent is gained, the patient will be seen during preoperative 
assessment by the research nurse or midwife to obtain written consent. Two copies of the 
completed consent form will be made (1 (original copy): to be filed for study data, 2: to be 
given to the patient, 3: to be inserted into medical notes). The patient will then be asked to 
complete Questionnaire 1.
On the day the patient is admitted to hospital for their operation, the patient will be 
approached by the research nurse or research midwife, who will confirm the patient is still 
happy to take part in the study. If the patient gives continued consent, the patient will then 
be allocated the intervention or control group as per opaque envelope allocation. This will 
then be marked  on the  consent form appropriately. The research nurse  or research 
midwife will then double check the allocation number matches on each of the following 
forms: Consent form, Questionnaire 1, Questionnaire 2. 
If the patient is allocated the intervention group, the video will be shown through use of a 
laptop or ipad, with earphones or in a private room. The patient will then be asked to 
complete Questionnaire 2. If control group is allocated, then no video will be shown, and 
the patient will be asked to complete Questionnaire 2. 
No questions regarding the video or operation will be answered by the research nurse or 
research midwife until after completion of Questionnaire 2 during phase 2 of the study. 
Potentially eligible patients within 8 months: 
–
Elective Caesarean section: 120 (4 patients per week with no recruitment during 
holiday periods). 60 patients per arm could potentially be approached.
–
TVT/TOT: 150 (5 patients per week with no recruitment during holiday periods). 75 
patients per arm could potentially be approached.
Of these, an estimated 3/10 will not accept to take part, or will be lost to follow up (drop out 
at stage 2 of the project). Sub-investigators may not be available for each of the operating 

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lists.
Target number of total patients to enrol in pilot study:
–
Elective Caesarean section: 60 in total. 30 patients per arm
–
TVT/TOT: 60 in total. 30 patients per arm.
Interventions
–
Elective Caesarean section: 
Intervention: 'C-Section Video' shown on a laptop. It will run through once only.
Control: No video
–
TVT/TOT: 
Intervention: 'TVT/TOT Video' shown on a laptop.  It will run through once only.
Control: No video
Adverse events/patient safety
No issues of patient safety should arise. An adverse event would be if the video caused 
undue additional anxiety due to a question the patient may have after watching it.
–
The videos will be presented to the communications manager of the RD&E trust 
for approval prior to showing them to the patients.
–
Should the patient have any further questions due to watching the video, having 
completed the questionnaires, it will be ensured that either a nurse or a doctor 
can answer these before the operation.
Any adverse  event will  be appropriately logged  and  submitted  to  the  Research  and 
Development department quarterly, if required.
Data collection and outcome measures:
Data will be collected by two delegates (sub-investigators: research nurse or research 
midwife).  
The data will be collected in the form of written questionnaires – see appendices for drafts.
Stage 1: Gaining consent and Baseline assessment:
1) Consent  forms  and  questionnaires  will  be  grouped  according  to  operative 
procedure, and numbered consecutively: 001-120. 
(001-060: TVT/TOT, 061-120: ELECTIVE CAESAREAN SECTION)
2) Potential patients will be given the Patient Information sheet by a member of their 
direct care team during clinic.
3) Three weeks before their operation, the patient will be telephoned by the research 
nurse or midwife, the project explained to them, and verbal consent will be gained 
for study participation.
4) Patients  who  have  given  verbal  consent  for  participation  will  be  seen  during 
preassessment and the patient will be asked to complete the written consent form 
and questionnaire 1.
5) On arrival at the hospital for their operation, the patients will be approached by the 
research nurse or research midwife to confirm consent and continue with phase 2 of 
the study:
Stage 2: Allocation and re-assessment
6) When the patient arrives for her operation, the research nurse or midwife will 

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approach the patient, and verbally confirm that she is still happy to continue with the 
project.
7) The  research  nurse  will  ensure  allocation number  matches on  all  documents, 
including questionnaire 2.
8) The patient will be asked to complete the second consent form that will then be 
inserted into the medical notes.
9) The research nurse will open an opaque envelope to view allocation of patient
10)If intervention: 
a)
The research nurse will give the laptop to the patient with the 
video  to  play.  No  comments  are  made  regarding  the  operative 
procedure etc.
b)
The research nurse marks the intervention box on the consent 
form.
c)
The  research nurse ensures the  patient  name  matches the 
consent  form,  and  the  number on  the  consent  form matches  the 
number on  'Questionnaire 2'.
d)
Following the viewing of the video, the research nurse  presents 
'Questionnaire 2' to the patient.
e)
The questionnaire will be collected and filed into the wallet with 
other questionnaires for that operative procedure group.
     10) If control: 
a) The research nurse marks the control box on the consent form.
b) The research nurse ensures the patient name matches the consent 
form, and the number on the consent form matches the number on 
'Questionnaire 2'.
c) The research nurse  presents the 'Questionnaire 2' to the patient. 
d) The questionnaires will be collected and filed into the wallet with other 
questionnaires for that operative procedure group.
Stage 3: Data Analysis
1. Data analysis:
The  co-investigator  will  be  given  the  wallets  with  the 
questionnaires and assimilate the data in an excel sheet, recording the participant 
number alongside the results.
2. Once all the data has been entered, the co-investigator will send the Excel sheet to 
the chief investigator as the initial stage of analysis, and date and sign it.
3. Then the co-investigator will open the wallet containing the consent forms and 
record the allocation next to the participant number, and regroup the data.
4. The data will then be sent to the statistician in order to proceed to statistical 
analysis.
Note on Blinding:
As the participant number and the subsequent allocation will be completely random as per 
point 8), the initial stage of the data assimilation onto the Excel sheet will be performed 
blindly as the co-investigator will not know which participant number corresponds to which 
study arm. As this document will then be sent to the chief investigator this prevents the 
data from being altered once the allocation is viewed in the second stage (Stage 3, point 
1,2).
Data management and statistical analysis
Patient consent forms and questionnaires will be filed securely in a padlock protected 

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locker at the Research and Development Building, Wonford.
No patient identifiers will be recorded on home laptops or home computers. 
The data will be assimilated in an Excel Sheet and stored on a password protected 
computer/laptop.
Consent forms will be held for 3-6 months and then destroyed.
Additional data will be held for 5 years.
All  Data  Protection  guidelines  and  the  Data  Protection  act  will  be  adhered  to  for 
confidentiality purposes.
The  trust statistician  will  be approached  for advice  on  randomisation  of the  opaque 
envelopes.
The person who undertakes the role of randomisation will be recorded in the research 
study log.
Descriptive statistics of baseline characteristics will be compared between study groups to 
demonstrate the effectiveness of randomisation. Categorical data will be summarised as 
proportions and  percentages as appropriate with associated  confidence  intervals. No 
attempt will be made at this stage to make formal comparisons of outcome measures – 
this  will  be  done  in  the  eventual  definitive  study.  Summaries  of  secondary  outcome 
measures will also be produced in a similar manner to the above.
PROJECT MANAGEMENT
Personnel
Producing the video:
Animator: Consultant Anaesthetist
Producer and Voiceover: Consultant Obstetrician & Gynaecologist
Camerawoman and Editor: Communications and Corporate Affairs Officer
Writer,  Director  and  Researcher,  Creation  of  Storyboards:  Year  5  Intercalating 
Medical Student (2011/12)
Quality Control: Trust Communications Manager
The Study
There will be four delegates: 
Chief Investigator: Consultant Obstetrician & Gynaecologist.
Co-Investigator: Foundation Year 1 Doctor, RD&E (2013-14)
2x Sub-Investigators: 
Until  December  2012:  Clinical  Medical  Student  and 
Foundation doctor 
From July 2013: Research nurse and research midwife
Statistician: Hospital Trust Statistician
Project Responsibilities:
Data storage/monitoring: Sub-Investigators 
Consenting:  Sub-Investigators
Recruitment:  Sub-Investigators
Statistical advice: Hospital Trust Statistician
Data analysis: Co-investigator
Write-up: Co-investigator and Chief Investigator
Additional Training Required: For the Sub-Investigators, if not already obtained, GCP 
Training will be required.
First Main Contact for the Study: Eleanor Zimmermann, Foundation Year 1 Doctor, RD&E.  
efzimmermann@doctors.org.uk, 07845508419

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Time-schedule
Start date: 31st August 2011 
Month
1 
(Sep)
2
3
4
5 
(Jan)
2012
6
7
April 2012 – 
June 2013 
Recruitment 
delay and re-
evaluation 
11 
(Jul)
2013
12
13
14
15
16
17
(Jan 
2014)
18
19
20
21
22
23
24
(Aug 
2014)
Create 
Videos
X
X
Protocol 
Submission
X
X
Ethics 
Submission
X
Delegate 
recruitment
X
Patient 
Enrolment* 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Research 
staff 
recruitmend
X
Data Entry
X
X
X
X
X
X
X
Data 
Analysis 
and write-up
X
X
X
*Should the necessary minimum number of patients required be recruited before month 13 
then patient enrolment will cease accordingly.
Day-to-day study management
Day to day management will be ensured by the Co-investigator, Foundation Year 1 Doctor.
Additional  delegates  recruited,  if  not  GCP  trained,  will  be  notified  to  the  Research 
department and be registered for a training day.
ETHICAL CONSIDERATIONS
An Integrated Research Application System Form is being completed for ethics approval.
Written consent will be gained from patients for participation. See appendices
Confidentiality: 
•
Questionnaires  will  not  contain  any  patient  details  other  than  demographic 
information. 
•
Questionnaires will  record  participant  number,  which  will  be  recorded  with the 
consent form. 
•
One original consent form will be collected and two copies of the complete form will 
be made. One will be filed securely with co-investigator, one will be given to the 
patient, and the other inserted into medical notes. 
•
Documents containing patient identifiers will be held for 3-6 months from study end 
and then shredded.
•
All other documentation will be held for 5 years.
Any queries patients may have regarding the study will be answered by the research team 
(Delegate A or B) prior to obtaining consent during Stage 1 of the study.
Participants willing to receive a copy of the study findings will indicate this in the consent 
form. These patients will be sent the information within 6 months of study end.

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BUDGET SUMMARY AND COSTINGS
Please see separate budget listing.
Funding of £250 has been obtained through the May Sullivan Research Prize towards 
costs of the project. 
A small grants application (R&D) will be made once protocol has been accepted.
POSSIBLE IMPLICATIONS OF STUDY
The results from the study will be entered into the following:
1)Conferences for presentation:
•
International Forum on Quality and Safety in Healthcare 
•
Annual Academic Meeting and William Blair Memorial Lecture
•
RCSEd Student Research Symposium
•
Association of Surgeons in Training
2) 
 
 Prizes
 
 
•
The Blair Bell Research Prize
3) Publications
•
The aim will be to publish the results in an educational peer reviewed journal
The videos created will be copyright protected by the Royal Devon and Exeter NHS 
Foundation Trust.
REFERENCES
1. Rankinen  S.  Salantera  S,  Heikkinen  K,  Johansson  K  et  al.  Expectations  and 
received knowledge by surgical patients. Int J Qual Health Care. 2007;19(2):113-
119
2.
Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative 
multimedia information on perioperative anxiety in patients undergoing procedures 
under regional anaesthesia. Br J Anaesth. 2010;104(3):369-374
3.
Doering S, Kaltzberger F, Rumpold G et al. Videotape preparation of patients before 
hip replacement surgery reduces stress. Psychosom Med. 2000;62:365-73
4. Shaw M, Beebe T, Tomshine P, Adlis S, Cass O. A randomized, controlled trial of 
interactive,  multimedia  software  for  patient  colonoscopy  education.  J  Clin 
Gastronter. 2001;32(2):142-147
APPENDICES/ANNEXES Study questionnaires and consent forms

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PIVOT: Patient Information Videos on Operations Trial
Patient Information Sheet
Patient Education on Common Surgical Procedures:
Using Rapid Sequence Animation Videos
Dear Patient,
Before you have your operation at the Royal Devon and Exeter NHS Trust, Wonford 
Hospital, we would like to ask you if you would consider taking part in a small research 
project for an educational resource. Please read the following information in order to gain a 
better understanding of what the project involves, and what the study aims to achieve.
We have created two short animation videos which aim to help patients prepare for their 
stay in hospital for common surgical procedures. In particular the videos cover the elective 
caesarian section and trans-vaginal/trans-obturator tape procedure, and this is why you 
are eligible to participate in the study. 
Our goal is to determine their benefit in helping patients prepare for their operation, as well 
as seeing whether they reduce anxiety before the procedure. We are looking to recruit a 
total of 120 patients. The study has been approved by the Southwest Ethics Committee by 
proportionate review and is sponsored by the Royal Devon and Exeter NHS Foundation 
Trust.
Three weeks before your operation, you will be called by our research nurse or midwife 
who will ask you if you would like to participate in the study. If you decide to take part in the 
project, when you come into hospital for your preoperative assessment, you will be asked 
to fill in a written consent form and questionnaire about how you feel and how well 
prepared you feel for your operation. This should take about 20 minutes. Then, you will be 
seen by the research nurse or midwife when you come into hospital for your operation, 
and will either be shown the video about your operation, or not shown it. (This is to help 
the results be more accurate when analysing them)  We will then ask you to complete the 
same questionnaire. 
This project will help us assess the overall benefit of these videos as an education tool 
which would be accessible to patients at home, and would complement their hospital stay. 
If they are found to be of use to patients, they would be used together with current means 
of giving information, such as leaflets, and this could also offer the opportunity to produce 
more videos to cover other common surgical procedures as well.
The questionnaires will be collected anonymously, and no patient identifiers will be used. 
You will be allocated a unique identification number ensuring privacy and respecting your 
right to confidentiality. At all times your data will remain anonymous and your name will not 
appear on any of the results. As this study is entirely voluntary, you will be free to withdraw 
at any time, without providing a reason. If you do decide to withdraw it will not affect the 
standard of your routine clinical care and we will safely destroy any questionnaires or 

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consent forms you may have completed.
If you decide to take part, you will be able to choose whether you would like to be informed 
of the study results, in which case we will keep your consent form for a maximum of six 
months before safely destroying it so we can post the summary of our findings to you. 
Otherwise, your consent form will be destroyed three months after study completion, which 
is estimated to be in November 2014. 
If you have any questions you would like to ask before you come into hospital, or before 
our research staff call you, please don't hesitate to ask. You can contact me by email or by 
phone, as below.
Please take your time to consider participation in this study and feel free to discuss it with 
others.
Many thanks for taking the time to read this letter,
Dr Eleanor Zimmermann BSc BMBS
Co-Investigator for PIVOT Study
efzimmermann@doctors.org.uk
07845508419

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PIVOT: Patient Information Videos on Operations Trial
Operation: TRANS-VAGINAL TAPE / TRANS-OBTURATOR TAPE
Affix Patient Sticker here:
Participant Number:
Allocation*: (delete as appropriate)
*To be completed at Stage 2 of study
INTERVENTION / CONTROL*
CONSENT FORM
To be completed before allocation.
I hereby give my consent to participate in the pilot project entitled “PIVOT: Patient 
Information Videos on Operations Trial”. 
  
  INITIALS
•
I have read the information sheet dated  ………..…....   and have been given a 
copy to keep. I have had the opportunity to consider the information, ask 
questions and have had these answered satisfactorily.
•
I  understand  that  may  be  presented  with  an  educational  video  about  my 
surgical procedure, or may not, depending on my allocation.
•
I  understand  that  should  I  have  any  questions  about  my  operation  after 
watching the video, every effort will be made to ensure they get answered.
•
I understand that the questionnaire is anonymous, and that every effort will be 
made to keep my details confidential.
•
I understand that the information I give in the questionnaires will be entered 
onto a study database. This database will hold anonymised data and may be 
accessed by members of the Research team regulatory authorities or from the 
NHS Trust, where it is relevant to my taking part in this research. 
•
I understand that my participation is voluntary and that I am free to withdraw at 
any time without giving any reason, without my medical care or legal rights 
being affected.
•
I understand that copies of this consent form will be made where necessary, 
and a copy will be retained in my medical notes, and the original will be filed 
securely until up to six months after study end, when it will be shredded to 
ensure data protection.
I would like to / would not like to receive a summary of the study findings in the post after study end 
(please delete as appropriate) 
PRINTED NAME (PATIENT)
PRINTED NAME (RESEARCHER)
…..............................................................
….................................................................
SIGNATURE and DATE
SIGNATURE and DATE
….........................................................
…..........................................................
When completed: 1 for participant; 1 for researcher site file (original); 1 to be kept in medical notes.

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PIVOT: Patient Information Videos on Operations Trial
Operation: ELECTIVE CAESAREAN SECTION
Affix Patient Sticker here:
Participant Number:
Allocation*: (delete as appropriate)
*To be completed at Stage 2 of study
INTERVENTION / CONTROL*
CONSENT FORM
To be completed before allocation.
I hereby give my consent to participate in the pilot project entitled “PIVOT: Patient 
Information Videos on Operations Trial”. 
  
  INITIALS
•
I have read the information sheet dated  ………..…....   and have been given a 
copy to keep. I have had the opportunity to consider the information, ask 
questions and have had these answered satisfactorily.
•
I understand that  I may be presented with an educational video about my 
surgical procedure, or may not, depending on my allocation.
•
I  understand  that  should  I  have  any  questions  about  my  operation  after 
watching the video, every effort will be made to ensure they get answered.
•
The questionnaire is anonymous, and that every effort will be made to keep my 
details confidential.
•
I understand that the information I give in the questionnaires will be entered 
onto a study database. This database will hold anonymised data and may be 
accessed by members of the Research team regulatory authorities or from the 
NHS Trust, where it is relevant to my taking part in this research. 
•
I understand that my participation is voluntary and that I am free to withdraw at 
any time without giving any reason, without my medical care or legal rights 
being affected.
•
I understand that copies of this consent form will be made where necessary, 
and a copy will be retained in my medical notes, and the original will be filed 
securely until up to six months after study end, when it will be shredded to 
ensure data protection.
I would like to / would not like to receive a summary of the study findings in the post after study end 
(please delete as appropriate) 
PRINTED NAME (PATIENT)
PRINTED NAME (RESEARCHER)
…..............................................................
….................................................................
SIGNATURE and DATE
SIGNATURE and DATE
….........................................................
…..........................................................
When completed: 1 for participant; 1 for researcher site file (original); 1 to be kept in medical notes.

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PIVOT: Patient Information Videos on Operations Trial
Patient Education on Common Surgical Procedures:
Using Rapid Sequence Animation Videos
QUESTIONNAIRE 1 :  to be completed by the patient after verbal consent gained by 
research nurse, approximately three weeks before the operation (stage 1)
Operation: TRANS-VAGINAL / TRANS-OBTURATOR TAPE
Participant Number:
001
ABOUT YOU
1- Please select the appropriate box for each category:
Age
<24
25-29
30-39
40-49
50-59
60-69
70-79
>80
Education Level
Secondary 
school
GCSEs
College / A - levels
Diploma
Undergraduate 
degree
Postgraduate 
degree
Employment status 
Unemployed
Employed 
Student
Retired
Other
Do you / did you work in healthcare?  
Yes
No
Have you had this operation before?
Yes
No

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QUESTIONNAIRE
A- PREOPERATIVE ANXIETY
1- Please rate your anxiety regarding your procedure below, with 0 being not anxious, and 
10 being extremely anxious, by putting an X on the line below:
0
1
2
3
4
5
6
7
8
9
10
Not anxious
Moderately anxious
       Extremely anxious
State Trait Anxiety Inventory
2- Please read each statement and select the appropriate response to indicate how you 
feel right now, that is, at this very moment. There are no right or wrong answers. Do not 
spend too much time on any one statement but give the answer which seems to describe 
your present feelings best.
1
2
    3
4
Not at all 
A little 
Somewhat 
Very Much So 
1.
I feel calm 
1
2
3
4
2.
I feel secure 
1
2
3
4
3.
I feel tense 
1
2
3
4
4.
I feel strained 
1
2
3
4
5.
I feel at ease 
1
2
3
4
6.
I feel upset 
1
2
3
4
7.
I am presently worrying 
over possible misfortunes                  
1
2
3
4
8.
I feel satisfied 
1
2
3
4
9.
I feel frightened 
1
2
3
4
10.
I feel uncomfortable 
1
2
3
4
11.
I feel self confident 
1
2
3
4
12.
I feel nervous 
1
2
3
4
13.
I feel jittery 
1
2
3
4
14.
I feel indecisive 
1
2
3
4
15.
I am relaxed 
1
2
3
4
16.
I feel content 
1
2
3
4
17.
I am worried 
1
2
3
4
18.
I feel confused 
1
2
3
4
19.
I feel steady 
1
2
3
4
20.
I feel pleasant 
1
2
3
4
TOTAL SCORE 
(to be filled in by research nurse):
          /80
Verified by co-investigator?
(initials)

Version 4.0
08/07/2013
B- PREOPERATIVE KNOWLEDGE
How informed do you feel about your condition?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How informed do you feel about the reasons why this operation has been offered to 
you?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately informed
      
      Extremely Well Informed
Do you feel ready for the operation?
1
2
3
4
5
6
7
8
9
10
Not at all ready
         
Moderately ready
      
      
      Extremely ready
Do you feel you know what to expect in the operating theatre?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
      Moderate
      
      
         Extremely Well 
Do you feel you understand what the surgeon will do in the operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately informed
      
      Extremely Well Informed
Do you know how your anaesthetic will be given to you?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How  well  do  you  think  you  have  been  informed  of  the  side  effects  of  the 
anaesthetic?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Are you aware of the possible complications and risks involved in your operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you know how long you are likely to stay in hospital?

Version 4.0
08/07/2013
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
How well do you feel you have been explained the benefit and success rate of the 
operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
     Moderately 
      
      
     
         Extremely well
How well informed do you feel about your recovery period after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel you have questions you would have liked to have asked that have not 
been answered?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Some questions
      
      
     A lot of questions
Many thanks for your time and honesty. This completes the questionnaire, and we look 
forward to seeing you again soon, to complete the second stage of the project.
Best wishes,
Dr Eleanor Zimmermann
Co-Investigator for PIVOT Study

Version 4.0
08/07/2013
PIVOT: Patient Information Videos on Operations Trial
Patient Education on Common Surgical Procedures:
Using Rapid Sequence Animation Videos
QUESTIONNAIRE 1 :  to be completed by the patient after verbal consent gained by 
research midwife, approximately three weeks before the operation (stage 1)
Operation: ELECTIVE CAESAREAN SECTION
Participant Number:
061
ABOUT YOU
1- Please select the appropriate box for each category:
Age
<24
25-29
30-39
40-49
>50
Education Level
Secondary 
school
GCSEs
College / A - levels
Diploma
Undergraduate 
degree
Postgraduate 
degree
Employment status (when not on maternity leave)
Unemployed
Employed 
Student
Other
Do you work in healthcare?  
Yes
No
Have you had this operation before?
Yes
No

Version 4.0
08/07/2013
QUESTIONNAIRE
A- PREOPERATIVE ANXIETY
1- Please rate your anxiety regarding your procedure below, with 0 being not anxious, and 
10 being extremely anxious, by putting an X on the line below:
0
1
2
3
4
5
6
7
8
9
10
Not anxious
Moderately anxious
       Extremely anxious
State Trait Anxiety Inventory
2- Please read each statement and select the appropriate response to indicate how you 
feel right now, that is, at this very moment. There are no right or wrong answers. Do not 
spend too much time on any one statement but give the answer which seems to describe 
your present feelings best.
1
2
    3
4
Not at all 
A little 
Somewhat 
Very Much So 
21.
I feel calm 
1
2
3
4
22.
I feel secure 
1
2
3
4
23.
I feel tense 
1
2
3
4
24.
I feel strained 
1
2
3
4
25.
I feel at ease 
1
2
3
4
26.
I feel upset 
1
2
3
4
27.
I am presently worrying 
over possible misfortunes                  
1
2
3
4
28.
I feel satisfied 
1
2
3
4
29.
I feel frightened 
1
2
3
4
30.
I feel uncomfortable 
1
2
3
4
31.
I feel self confident 
1
2
3
4
32.
I feel nervous 
1
2
3
4
33.
I feel jittery 
1
2
3
4
34.
I feel indecisive 
1
2
3
4
35.
I am relaxed 
1
2
3
4
36.
I feel content 
1
2
3
4
37.
I am worried 
1
2
3
4
38.
I feel confused 
1
2
3
4
39.
I feel steady 
1
2
3
4
40.
I feel pleasant 
1
2
3
4
TOTAL SCORE 
(to be filled in by research nurse):
          /80
Verified by co-investigator?
(initials)
B- PREOPERATIVE KNOWLEDGE

Version 4.0
08/07/2013
How informed do you feel about the reasons for your having a caesarean section?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel ready for the operation?
1
2
3
4
5
6
7
8
9
10
Not at all ready
         
Moderately ready
      
      
      Extremely ready
Do you feel you know what to expect in the operating theatre?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
      Moderate
      
      
         Extremely Well 
Do you feel you understand what the surgeon will do in the operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         Moderately informed
      
      Extremely Well Informed
Do you know how your anaesthetic will be given to you?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How  well  do  you  think  you  have  been  informed  of  the  side  effects  of  the 
anaesthetic?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Are you aware of the possible complications and risks involved in your operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you know where you and your baby will go after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you know when you can start breastfeeding your baby?

Version 4.0
08/07/2013
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How aware are you of the long term implications of having a c-section?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
Do you know how long you are likely to stay in hospital?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
How well informed do you feel about your recovery period after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel you have questions you would have liked to have asked that have not 
been answered?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Some questions
      
      
     A lot of questions
Many thanks for your time and honesty. This completes the questionnaire, and we hope 
you have a quick recovery from your operation! 
Best wishes,
Dr Eleanor Zimmermann
Co-Investigator for PIVOT Study

Version 4.0
08/07/2013
PIVOT: Patient Information Videos on Operations Trial
Patient Education on Common Surgical Procedures:
Using Rapid Sequence Animation Videos
QUESTIONNAIRE 2 : to be completed on the day of the operation (Stage 2)
Operation: TRANS-VAGINAL / TRANS-OBTURATOR TAPE
Participant Number:
001
The questionnaire is three pages long, and should take approximately 15 minutes to 
complete.
Please turn over to start the questionnaire.

Version 4.0
08/07/2013
QUESTIONNAIRE 2
A- PREOPERATIVE ANXIETY
1- Please rate your anxiety regarding your procedure below, with 0 being not anxious, and 
10 being extremely anxious, by putting an X on the line below:
0
1
2
3
4
5
6
7
8
9
10
Not anxious
Moderately anxious
       Extremely anxious
State Trait Anxiety Inventory
2- Please read each statement and select the appropriate response to indicate how you 
feel right now, that is, at this very moment. There are no right or wrong answers. Do not 
spend too much time on any one statement but give the answer which seems to describe 
your present feelings best.
1
2
    3
4
Not at all 
A little 
Somewhat 
Very Much So 
41.
I feel calm 
1
2
3
4
42.
I feel secure 
1
2
3
4
43.
I feel tense 
1
2
3
4
44.
I feel strained 
1
2
3
4
45.
I feel at ease 
1
2
3
4
46.
I feel upset 
1
2
3
4
47.
I am presently worrying 
over possible misfortunes                  
1
2
3
4
48.
I feel satisfied 
1
2
3
4
49.
I feel frightened 
1
2
3
4
I feel uncomfortable 
1
2
3
4
50.
I feel self confident 
1
2
3
4
51.
I feel nervous 
1
2
3
4
52.
I feel jittery 
1
2
3
4
53.
I feel indecisive 
1
2
3
4
54.
I am relaxed 
1
2
3
4
55.
I feel content 
1
2
3
4
56.
I am worried 
1
2
3
4
57.
I feel confused 
1
2
3
4
58.
I feel steady 
1
2
3
4
59.
I feel pleasant 
1
2
3
4
TOTAL SCORE 
(to be filled in by sub-investigator):
          /80
Verified by co-investigator?
(initials)

Version 4.0
08/07/2013
B- PREOPERATIVE KNOWLEDGE
How informed do you feel about your condition?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How informed do you feel about the reasons why this operation has been offered to 
you?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately informed
      
      Extremely Well Informed
Do you feel ready for the operation?
1
2
3
4
5
6
7
8
9
10
Not at all ready
         
Moderately ready
      
      
      Extremely ready
Do you feel you know what to expect in the operating theatre?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
      Moderate
      
      
         Extremely Well 
Do you feel you understand what the surgeon will do in the operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately informed
      
      Extremely Well Informed
Do you know how your anaesthetic will be given to you?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How  well  do  you  think  you  have  been  informed  of  the  side  effects  of  the 
anaesthetic?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Are you aware of the possible complications and risks involved in your operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed

Version 4.0
08/07/2013
Do you know how long you are likely to stay in hospital?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
How well do you feel you have been explained the benefit and success rate of the 
operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
     Moderately 
      
      
     
         Extremely well
How well informed do you feel about your recovery period after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel you have questions you would have liked to have asked that have not 
been answered?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Some questions
      
      
     A lot of questions
Many thanks for your time and honesty. This completes the questionnaire, and we look 
forward to seeing you again soon, to complete the second stage of the project.
Best wishes,
Dr Eleanor Zimmermann
Co-Investigator for PIVOT Study

Version 4.0
08/07/2013
PIVOT: Patient Information Videos on Operations Trial
Patient Education on Common Surgical Procedures:
Using Rapid Sequence Animation Videos
QUESTIONNAIRE 2 : to be completed on the day of the operation (Stage 2)
Operation: ELECTIVE CAESAREAN SECTION
Participant Number:
061
The questionnaire is three pages long, and should take approximately 15 minutes to 
complete.
Please turn over to start the questionnaire.

Version 4.0
08/07/2013
QUESTIONNAIRE 2
A- PREOPERATIVE ANXIETY
1- Please rate your anxiety regarding your procedure below, with 0 being not anxious, and 
10 being extremely anxious, by putting an X on the line below:
0
1
2
3
4
5
6
7
8
9
10
Not anxious
Moderately anxious
       Extremely anxious
State Trait Anxiety Inventory
2- Please read each statement and select the appropriate response to indicate how you 
feel right now, that is, at this very moment. There are no right or wrong answers. Do not 
spend too much time on any one statement but give the answer which seems to describe 
your present feelings best.
1
2
    3
4
Not at all 
A little 
Somewhat 
Very Much So 
60.
I feel calm 
1
2
3
4
61.
I feel secure 
1
2
3
4
62.
I feel tense 
1
2
3
4
63.
I feel strained 
1
2
3
4
64.
I feel at ease 
1
2
3
4
65.
I feel upset 
1
2
3
4
66.
I am presently worrying 
over possible misfortunes                  
1
2
3
4
67.
I feel satisfied 
1
2
3
4
68.
I feel frightened 
1
2
3
4
69.
I feel uncomfortable 
1
2
3
4
70.
I feel self confident 
1
2
3
4
71.
I feel nervous 
1
2
3
4
72.
I feel jittery 
1
2
3
4
73.
I feel indecisive 
1
2
3
4
74.
I am relaxed 
1
2
3
4
75.
I feel content 
1
2
3
4
76.
I am worried 
1
2
3
4
77.
I feel confused 
1
2
3
4
78.
I feel steady 
1
2
3
4
79.
I feel pleasant 
1
2
3
4
TOTAL SCORE 
(to be filled in by research nurse):
          /80
Verified by co-investigator?
(initials)
B- PREOPERATIVE KNOWLEDGE

Version 4.0
08/07/2013
How informed do you feel about the reasons for your having a caesarean section?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel ready for the operation?
1
2
3
4
5
6
7
8
9
10
Not at all ready
         
Moderately ready
      
      
      Extremely ready
Do you feel you know what to expect in the operating theatre?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
      Moderate
      
      
         Extremely Well 
Do you feel you understand what the surgeon will do in the operation?
1
2
3
4
5
6
7
8
9
10
Not at all 
         Moderately informed
      
      Extremely Well Informed
Do you know how your anaesthetic will be given to you?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How  well  do  you  think  you  have  been  informed  of  the  side  effects  of  the 
anaesthetic?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Are you aware of the possible complications and risks involved in your operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you know where you and your baby will go after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed

Version 4.0
08/07/2013
Do you know when you can start breastfeeding your baby?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
How aware are you of the long term implications of having a c-section?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
Do you know how long you are likely to stay in hospital?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Moderately aware
      
      
      Extremely aware
How well informed do you feel about your recovery period after the operation?
1
2
3
4
5
6
7
8
9
10
Not at all informed
         Moderately informed
      
      Extremely Well Informed
Do you feel you have questions you would have liked to have asked that have not 
been answered?
1
2
3
4
5
6
7
8
9
10
Not at all 
         
Some questions
      
      
     A lot of questions
Many thanks for your time and honesty. This completes the questionnaire, and we hope 
you have a quick recovery from your operation! 
Best wishes,
Dr Eleanor Zimmermann
Co-Investigator for PIVOT Study