A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
Phase: NA
Conditions: Facial Palsy
Sponsor: Oxford University Hospitals NHS Trust

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Study Title:  A pilot study evaluating the effectiveness of information and therapy guides for improving the 
psychosocial wellbeing of people with facial palsy. 
 
Ethics Ref: 19/SC/0288 
Date and Version No: 15th June 2020 – Version 4 
 
Chief Investigator: 
Dr Matthew Hotton, Clinical Psychologist, The Oxford Facial Palsy 
Service, John Radcliffe Hospital, Oxford 
Matthew.Hotton@nhs.net, 01865 234714 
Investigators:  
Dr Louise Dalton, Consultant Clinical Psychologist, The Oxford Facial 
Palsy Service, John Radcliffe Hospital 
Esme Huggons, Honorary Assistant Psychologist, The Oxford Facial Palsy 
Service, John Radcliffe Hospital 
Sponsor:  
Oxford University Hospitals NHS Foundation Trust  
Funder: 
The VTCT Foundation 
92 Dynevor Road 
London 
N16 0HA 
Chief Investigator Signature:   
 
There are no potential conflicts of interest 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, HRA, host organisation, and members of the Research Ethics Committee, 
unless authorised to do so. 
 

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TABLE OF CONTENTS 
To update table of contents (TOC), hover cursor over the table and ‘right click’.  Choose ‘update field’, 
then ‘update entire table’. 
 
1. 
SYNOPSIS ............................................................................................................................................... 4 
2. 
ABBREVIATIONS ..................................................................................................................................... 4 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 5 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................... 6 
5. 
STUDY DESIGN ....................................................................................................................................... 7 
6. 
PARTICIPANT IDENTIFICATION .............................................................................................................. 9 
6.1. 
Study Participants .......................................................................................................................... 9 
6.2. 
Inclusion Criteria ............................................................................................................................ 9 
6.3. 
Exclusion Criteria ........................................................................................................................... 9 
7. 
STUDY PROCEDURES ........................................................................................................................... 10 
7.1. 
Recruitment ................................................................................................................................. 10 
7.2. 
Screening and Eligibility Assessment ........................................................................................... 11 
7.3. 
Informed Consent ........................................................................................................................ 13 
7.4. 
Baseline Assessments .................................................................................................................. 13 
7.5. 
Subsequent Visits ........................................................................................................................ 15 
7.6. 
Discontinuation/Withdrawal of Participants from Study ............................................................ 15 
7.7. 
Definition of End of Study ........................................................................................................... 16 
8. 
INTERVENTIONS ................................................................................................................................... 16 
9. 
STATISTICS AND ANALYSIS ................................................................................................................... 17 
9.1. 
Description of Statistical Methods .............................................................................................. 17 
9.2. 
The Number of Participants ........................................................................................................ 17 
9.3. 
Analysis of Outcome Measures ................................................................................................... 17 
10. 
DATA MANAGEMENT ...................................................................................................................... 17 
10.1. 
Access to Data ......................................................................................................................... 18 
10.2. 
Data Recording and Record Keeping ....................................................................................... 18 
11. 
QUALITY ASSURANCE PROCEDURES ............................................................................................... 18 
12. 
ETHICAL AND REGULATORY CONSIDERATIONS ............................................................................... 18 
12.1. 
Declaration of Helsinki............................................................................................................. 18 
12.2. 
Guidelines for Good Clinical Practice ...................................................................................... 19 
12.3. 
Approvals ................................................................................................................................. 19 

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12.4. 
Reporting ................................................................................................................................. 19 
12.5. 
Participant Confidentiality ....................................................................................................... 19 
12.6. 
Expenses and Benefits ............................................................................................................. 19 
12.7. 
Other Ethical Considerations ................................................................................................... 19 
13. 
FINANCE AND INSURANCE .............................................................................................................. 20 
13.1. 
Funding .................................................................................................................................... 20 
13.2. 
Insurance ................................................................................................................................. 20 
14. 
PUBLICATION POLICY ....................................................................................................................... 20 
15. 
REFERENCES .................................................................................................................................... 21 
16. 
APPENDIX A:  AMENDMENT HISTORY ............................................................................................. 23 
17. 
APPENDIX B: FLOW CHART…………………………………………………………………………………………………………24 
 
 
 

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1. SYNOPSIS 
 
Study Title 
A pilot study evaluating the effectiveness of information and therapy guides for 
improving the psychosocial wellbeing of people with facial palsy. 
Study Design 
Feasibility/pilot study 
Study Participants 
Adults with a diagnosis of facial palsy and/or their friends and relatives 
Planned Sample Size 
140 participants 
Planned Study Period 
July 2019 – May 2021 
 
Objectives 
Outcome Measures 
Primary 
 
To evaluate the effectiveness of 
Information and Therapy guides (ITG) 
at improving the psychosocial 
wellbeing of people with a diagnosis 
of facial palsy  
Hospital Anxiety and Depression 
Scale 
Face-Q – Social function 
Face-Q – Psychological function 
Face-Q – Appearance-related 
psychosocial distress 
Facial Disability Index 
 
Secondary 
 
To evaluate the effectiveness of 
Information and Therapy guides at 
improving the psychosocial welling of 
family and friends of people with a 
diagnosis of facial palsy 
Hospital Anxiety and Depression 
Scale 
Adult Carer Quality of Life  
Questionnaire 
 
Tertiary 
To evaluate the acceptability and 
usability of Information and Therapy 
guides for people with facial palsy 
and/or their family and friends 
Patient satisfaction questionnaire 
 
2. ABBREVIATIONS 
 
ANCOVA 
Analysis of Covariance 
CBT 
Cognitive Behavioural Therapy 
CI 
Chief Investigator 
CRF 
Case Report Form 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
HRA 
Health Research Authority 
ICF 
Informed Consent Form 

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ITG 
Information & Therapy Guide 
NHS 
National Health Service 
NRES 
National Research Ethics Service 
OXTREC 
Oxford Tropical Research Ethics Committee 
PI 
Principal Investigator 
PIL 
Participant/ Patient Information Leaflet 
R&D 
NHS Trust R&D Department 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedure 
 
3. BACKGROUND AND RATIONALE 
 
Facial palsy is characterised by facial muscle weakness, typically due to facial nerve damage, and affects 
between 23 to 35 people per 100 000 (1). By far the most common cause of facial palsy is Bell’s palsy, 
which affects approximately 20.2 people per 100 000 and is likely to have a herpetic trigger. Although up 
to 70% of people with Bell’s palsy will make a full recovery, facial palsy is a condition with a 
heterogeneous presentation, with some people experiencing temporary unilateral weakness, with others 
having permanent, bilateral facial paralysis (2). 
Some of the physical sequelae of facial palsy include difficulties with: eating, drinking, speaking, eyelid 
closure, pain, taste, muscle atrophy and synkinesis (3). Current management options include: injections 
of Botulinum Toxin A; facial therapy; facial reanimation surgery and surgery to the eyelid and/or tear 
duct (4). However, it is also important to note that it is not known how many patients with facial palsy 
have made a spontaneous recovery without treatment, as they are unlikely to present to facial palsy 
services. 
Although there is no direct relationship between the degree of appearance change and reported distress 
(5), people with facial palsy typically experience higher levels of distress, compared to other forms of 
visible facial difference (6). This is believed to be due to the impact that facial palsy has on the face’s 
ability to express emotions, which is a crucial aspect of face-to-face communication (7). This lack of facial 
expression of emotion can be interpreted by others as an indicator of boredom, hostility or disinterest, 
resulting in a higher number of negative social interactions (6). Indeed, impairment in smiling has been 
shown to be a significant predictor of anxiety and depression in individuals with facial palsy (8). 
In a sample of 103 patients with facial palsy in the United Kingdom, 32.7% had significant levels of 
anxiety and 31.3% had significant levels of depression (5). This is compared to an estimated 8.33% for 
the general UK population (9). Furthermore, low self-esteem has been shown to be one of the strongest 
predictors of distress among people with facial palsy (10), indicating that difficulties with anxiety, 
depression and self-esteem are all significant factors which can affect the wellbeing of individuals with 
facial palsy. 

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Facial palsy can not only have an impact on the individual with facial palsy, but also on the physical and 
psychological wellbeing of friends, family members and carers. Indeed, the impact of caregiving on 
physical and psychosocial outcomes is well documented (11) and highlights the importance of focusing 
on not only the wellbeing of patients with facial palsy, but also their family members or carers. 
The difficulties that patients across the United Kingdom experience accessing facial palsy services is well 
documented, with a freedom of information request in 2012 revealing that only 13% of Clinical 
Commissioning Groups routinely fund all types of facial palsy treatments, without requiring  specialist 
funding approval (12). This means that patients often travel a long distance in order to access specialist 
multidisciplinary services, such as the Oxford Facial Palsy Service and may go some time without 
accessing support during the early stages of their condition. 
Despite the significant impact of facial palsy on the psychosocial wellbeing of people with facial palsy, 
there is no research investigating the effectiveness of psychological interventions for people with this 
condition. As a result, a recent consensus document following a Delphi survey of patients, carers, 
clinicians and researchers highlighted research into identifying the types of psychological intervention 
that are most effective for people with facial palsy as being one of the key research priorities (13). 
Although not researched yet in a facial palsy population, one type of psychological intervention that has 
been found to be effective at improving the psychosocial wellbeing of people with visible differences has 
been psychological self-help, including online or booklet-based self-guided cognitive behavioural therapy 
(CBT; see 14 for a review). With this in mind, the Oxford Facial Palsy Service secured funding from the 
charity “VTCT Foundation” to develop seven self-guided information and therapy guides (ITGs), for 
people with facial palsy and/or their friends or relatives, using evidence-based interventions such as 
cognitive behavioural therapy, social skills training and acceptance and commitment therapy. 
This current study aims to pilot the use of these guides in order to assess their effectiveness at improving 
the psychosocial wellbeing of people with facial palsy and their friends and family. Eligible participants 
will complete a set of baseline measures prior to trialling the use of a relevant ITG over a period of four-
to-six weeks. After the four-to-six weeks, participants will re-complete the measures completed at 
baseline, along with a questionnaire assessing the usability and acceptability of the ITGs. 
4. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Timepoint(s) 
of 
evaluation of this 
outcome measure 
(if applicable) 
Primary Objective 
To evaluate the effectiveness of 
Information and Therapy guides at 
improving the psychosocial 
wellbeing of people with a diagnosis 
of facial palsy 
Hospital Anxiety and Depression Scale 
Face-Q – Social function 
Face-Q – Psychological function 
Face-Q – Appearance-related psychosocial 
distress 
1) Prior to 
participant using 
ITG 
2) After participant 
has used ITG for 4-6 

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Facial Disability Index 
 
weeks 
Secondary Objectives 
To evaluate the effectiveness of 
Information and Therapy guides at 
improving the psychosocial welling 
of friends and relatives of people 
with a diagnosis of facial palsy 
Hospital Anxiety and Depression Scale 
Adult Carer Quality of Life  Questionnaire 
 
1) Prior to 
participant using 
ITG 
2) After participant 
has used ITG for 4-6 
weeks 
Tertiary Objectives 
To evaluate the acceptability and 
usability of Information and Therapy 
guides for people with facial palsy 
and/or their friends and relatives 
Participant satisfaction questionnaire 
1) After participant 
has used ITG for 2-3 
weeks 
2) After participant 
has used ITG for 4-6 
weeks 
 
5. STUDY DESIGN 
Given that this study represents an initial pilot of the use of ITGs for people with facial palsy (and/or their 
friends and relatives), all eligible participants will receive the intervention (i.e. there will be no control 
group). As a result, this study will have a repeated-measures design. 
Eligible participants will be recruited by one of two means: 
1) Face-to-face of recruitment of OUH NHS patients during clinics at the Oxford Facial Palsy Service 
2) Recruitment of people with facial palsy, not under the care of the Oxford Facial Palsy Service, 
through relevant web and social media pages (e.g. the Facial Palsy UK Facebook page) 
Potential participants who have expressed an interest in the study will be provided with an information 
sheet and if still interested they will be invited to provide written consent (via an online consent form; 
Survey Hero). They will then be screened for eligibility using an online screening questionnaire (also 
Survey Hero). Participants recruited in Oxford Facial Palsy Service clinics will complete the screening 
questionnaire on the researcher’s laptop during clinic or online at a later date if they wish to have more 
time to consider their participation in the study. Participants recruited on social media will be emailed a 
link to the screening questionnaire. Participants will have provided written consent for their email 
address to be shared with the research team. 
Eligible participants will then be invited to complete baseline questionnaires: 
People with facial palsy: Hospital Anxiety and Depression Scale; FACE-Q Satisfaction with appearance; 
FACE-Q Psychological function; FACE-Q Social function and Facial Disability Index. 
Friends, relatives or partners: Hospital Anxiety and Depression Scale and Adult Carer Quality of Life 
Questionnaire. 

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Like the consent forms and screening questionnaires, baseline questionnaires will be completed online 
via Survey Hero. 
Eligible participants will then be administered the relevant ITG. For eligible carers/relatives this will be 
the ITG entitled “Facial palsy: Advice for friends, family and partners”. For eligible participants with facial 
palsy, this will be determined by their score on the screening questionnaire. This process is outlined 
further in Section 7.2 ‘Screening and Eligibility Assessment’.  Participants will then utilise the ITG over a 
period of four-to-six weeks. Half-way through the intervention period (after 2-3 weeks), they will receive 
an email reminding them to complete the ITG and will be provided a web-link to complete a 
questionnaire designed for the purpose of the current study measuring the participants’ ratings of 
acceptability and usability of the ITGs (participant satisfaction questionnaire) on Survey Hero. 
At the end of the four-to-six week period, participants will be re-administered the baseline 
questionnaires (via web-link to Survey Hero), along with a questionnaire designed for the purpose of the 
current study measuring the participants’ ratings of acceptability and usability of the ITGs (participant 
satisfaction questionnaire). Participants will have a 2 week window to complete the final questionnaires 
after they have been sent to them at the end of the ITG trial period. If they do not complete the 
questionnaires in this window, they will be withdrawn from the study.  Participants with facial palsy will 
also be re-administered the initial screening questionnaire. This will indicate whether the participant is 
eligible to complete a further ITG. If this is the case, then their post-intervention questionnaires will 
serve as a new baseline and the participant will be invited to complete the new ITG over a second four-
to-six week period (followed by the same follow-up assessments as followed the first ITG). This process 
will occur up to a maximum of six times (reflecting the potential for a participant to trial all six ITGs). If 
they do not wish to complete further ITGs then the participant will be thanked for their involvement in 
the study and their involvement will be registered as ‘complete’. All participants will be provided with a 
separate email link to complete the relevant questionnaires at each stage (e.g. screening, baseline, 2-3 
week satisfaction, 4-6 week final questionnaires). The email will also remind them of their unique ID 
number, for them to enter at the start of the questionnaires. This will help their responses to be 
matched with their previous responses. 
We aim to trial the ITGs over a period of one year (July 2019 – May 2020). This will lead to the predicted 
sample sizes of 140 participants (120 with facial palsy, 20 per each of the 6 guides; 20 friends and family). 
This target is based on there being approximately 3000 people who have access to the Facial Palsy UK 
website. Given that approximately 1/3 people with facial palsy experience a significant level of distress 
(5); we hope that our ITGs would be relevant to, and accessible by, around 1000 people. 140 is therefore 
a conservative estimate of the number of participants that we will be able to recruit. Recruitment and 
completion will be monitored in case recruitment should be extended. 
Participants recruited from OUH NHS Foundation trust will be provided with an information sheet during 
their clinic appointment with the Oxford Facial Palsy Service. Potential participants will then be given the 
option to either provide written consent in clinic using Survey Hero on the researcher’s laptop, or at a 
later stage (via weblink to Survey Hero consent form).  
Participants recruited from social media will be provided with an information sheet via email and will 
provide written consent online using Survey Hero. Both people with facial palsy and their family 
members, friends and partners have access to Facial Palsy UK social media. Therefore both groups of 
participants can be recruited through this means. 

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6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
Participants with a diagnosis of facial palsy, of any severity and aetiology or friends/relatives/partners of 
a person with facial palsy. In all instances participants will be aged 18 years or older. 
 
6.2. Inclusion Criteria 
Participant with Facial Palsy: 
 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
Aged 18 years or above. 
• 
Current diagnosis of facial palsy, of any severity or aetiology. 
• 
Participants experience one or more psychosocial difficulties related to facial palsy ‘all the time’ 
or ‘a lot of the time’, as assessed by a screening questionnaire (outlined in further detail in 
Section 7.2) 
 
Participant who is a friend, family member or partner of someone with facial palsy: 
 
• 
Participant is willing and able to give informed consent for participation in the study. 
• 
Aged 18 years or above. 
• 
Is a friend, family member or partner of an adult with facial palsy, of any severity or aetiology. 
• 
Participants experience psychosocial difficulties related to supporting someone with facial palsy, 
as assessed by participant responding ‘all the time’ or ‘a lot of the time’ to one or more 
questions on a screening questionnaire (outlined in further detail in Section 7.2) 
6.3. Exclusion Criteria 
The participant may not enter the study if ANY of the following apply: 
Participant with Facial Palsy: 
• 
The participant is not in within the target age range (e.g. under the age of 18 years). 
• 
They are not an individual with a current diagnosis of facial palsy. 
• 
They do not speak enough English to understand the questionnaires or ITGs. 

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• 
They do not meet eligibility on the screening questionnaire (i.e. they 'never' or 'only occasionally' 
experience psychosocial difficulties associated with facial palsy (see section 7.2 Screening and 
Eligibility Assessment). 
 
Participant who is a friend, family member or partner of someone with facial palsy: 
• 
The participant is not in within the target age range (e.g. under the age of 18 years). 
• 
They are not a friend, family member or partner of an adult with a current diagnosis of facial 
palsy. 
• 
They do not speak enough English to understand the questionnaires or ITG. 
• 
They do not meet eligibility on the screening questionnaire (i.e. they 'never' or 'only occasionally' 
experience psychosocial difficulties associated with supporting someone with facial palsy (see 
section 7.2 Screening and Eligibility Assessment). 
 
Because participants will be using a unique ID number, it will not be possible for them to complete the 
screening questionnaire again, if their initial results indicate that they are ineligible. This is in order to 
prevent people from attempting screening multiple times to attempt to meet eligibility criteria. 
 
Participants with facial palsy will not be matched with participants who are friends, family or a partner. 
Therefore, participants with facial will be eligible to participate, even if a friend, family member or 
partner does not participate. Likewise, a friend, family member or partner will be eligible to participate 
even if the person with facial palsy does not participate. 
7. STUDY PROCEDURES 
7.1. Recruitment 
The participants in this study will be individuals with facial palsy and/or their family members/carers. 
They will be recruited by two means: 
1) Recruitment at Oxford Facial Palsy Service clinic appointments. A member of the research 
team, who will also be a member of the care team, will approach eligible patients and/or friends 
or relatives during their clinic appointment. Given that all patients with facial palsy are eligible to 
take part in the study, it will not be necessary to review medical records prior to clinic to identify 
eligible participants. All potential participants will be provided with an information sheet, and 
opportunity to ask questions about the information sheet, at their clinic appointment.  
 
Interested participants will provide written consent via completion of an online Consent Form 
(via Survey Hero). This will either be done in clinic on the researcher’s laptop, or if patients would 
like more time consider their involvement this can be done remotely online via Survey Hero.  

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They will be given a signed copy of their completed consent form.  Participants who have 
consented will then complete an online screening questionnaire (again either in clinic or 
remotely). If eligible, participants will complete baseline questionnaires via Survey Hero. Upon 
completion of questionnaires they will be sent the relevant ITG.  
For potential participants who are the friend, family member or partner of someone under the 
care of the Oxford Facial Palsy service, the process will be the same as above, with participants 
who are a friend, family member or partner providing informed consent prior to completion of 
screening questionnaires.   
 
2) Online recruitment, including social media. The United Kingdom’s leading facial palsy charity, 
Facial Palsy UK, has agreed to support recruitment for the current study through their platforms, 
including their Facebook page and research emailing lists. Advertisements will include the 
contact details for the lead researcher and interested participants will be invited to email the 
lead researcher for further information about the research project, including the information 
sheet. Once the participant has read the information sheet and indicated that they are keen to 
take part in the study they will be emailed a link on Survey Hero to complete an online consent 
form. They will be provided an electronic copy of their completed consent form. If they consent 
to take part they will then be sent a link to an online screening questionnaire. If eligible, they will 
then be sent a link to complete baseline questionnaires. Upon completion of questionnaires, 
they will be sent the relevant ITG. They will be sent either a physical copy in the post or an 
electronic copy via email (as indicated during completion of the relevant section of the Survey 
Hero baseline questionnaires). 
Advertisements will only directly target people with facial palsy themselves, rather than friends 
and relatives, with people with facial palsy being invited to take part and/or to nominate a friend 
or relative to take part. 
Researchers will only be recruiting participants from within the United Kingdom. 
7.2. Screening and Eligibility Assessment 
All interested participants recruited from the Oxford Facial Palsy Service will be given an information 
sheet during their clinic appointment. Participants recruited through social media will be sent the 
information sheet via email if they have contacted the lead researcher in response to advertisement. 
Once participants have provided consent (see section 7.3), a member of the research team will send 
interested participants a link to an online screening questionnaire. This will be completed remotely for 
participants recruited online and online on a laptop during clinic for participants attending the Oxford 
Facial Palsy Service clinic. Alternatively, if participants recruited in clinic wish to have more time to 
consider whether or not to participate, they will be able to complete online screening (and subsequent 
baseline assessments) remotely online. 
Screening: 
For potential participants who are friends or relatives of individuals with a diagnosis of facial palsy, this 
involves answering two questions in relation to supporting someone with facial palsy: 

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1) Supporting someone with facial palsy has an impact on my own wellbeing. 
2) I am having difficulties supporting someone with facial palsy. 
There are 5 potential responses to each question: all the time; a lot of the time; only occasionally; never 
or N/A. If a potential participant responds ‘only occasionally’, ‘all the time’ or ‘a lot of the time’ to one or 
both of the screening questions then they are eligible to complete the friends, family or partner ITG.  
For potential participants with a diagnosis of facial palsy, the ITG that participants first receive will be 
based on their response to six statements, each pertaining to a different ITG topic: 
1) I have developed facial palsy in the last six months and am having difficulties coping with the 
condition (ITG = Facial palsy: coping with the early stages) 
2) I have difficulties managing staring or comments and questions about my facial palsy (ITG = 
Facial palsy: coping with comments, questions and staring) 
3) My facial palsy makes it difficult for me to communicate as confidently as I’d like (ITG = Facial 
palsy: communicating with confidence) 
4) I feel anxious about having facial palsy (ITG = Facial palsy: managing anxiety) 
5) I feel low or miserable about having facial palsy (ITG = Facial palsy: managing your mood) 
6) Facial palsy affects how I feel about myself (self-esteem) (ITG = Facial palsy: building your self-
esteem) 
Participants are invited to rate each statement according to how frequently they experience each 
difficulty. There are 5 options: all the time; a lot of the time; only occasionally; never or N/A. Participants 
are eligible to complete ITGs if they have rated having difficulties relating to the topic of the ITG ‘all the 
time’ or ‘a lot of the time’. Participants will also be asked to rank the six statements in order of how 
much of a concern they are for them (1 = most important concern, 6 = least important concern). If 
participants are eligible to complete multiple ITGs (i.e. they rate experiencing difficulties ‘all the time’ or 
‘a lot of the time’ for multiple topics), then they will complete ITGs in order of how much of a concern 
that area is for the participant. . They will be informed that they may be able to complete the next ITG 
that they are eligible for, at the completion of the 4-6 week trial period for their initial ITG.  
At the completion of the 4-6 week trial period, participants will be invited to re-complete the original 
screening questionnaire and, if eligible (e.g. they still experience difficulties on one of the remaining 
topics ‘all the time’ or ‘a lot of the time’), will be invited to trial the next ITG. If they do not wish to 
complete further ITGs then the participant will be thanked for their involvement in the study and their 
involvement will be registered as ‘complete’ 
Participants who do not meet eligibility criteria will be thanked for their interest in the study and 
signposted to the Facial Palsy UK website for general information and advice for how to best manage 
facial palsy: 
Thank you for your interest in this study. Unfortunately you do not currently meet the inclusion criteria for 
this study. For further information and advice about managing facial palsy please visit facialpalsy.org.uk 
or contact your NHS facial palsy service. 
 

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The screening questionnaires will also ask potential participants to provide information about their (or 
their family member or relative’s) facial palsy diagnosis/type and date of onset.  
7.3. Informed Consent 
 
Participants must personally sign and date the latest approved version of the Informed Consent form 
before any study specific procedures are performed. As permitted by ‘eIDAS’ Regulation (EU) Number 
910/2014 framework for electronic signatures, this will be typewritten in Survey Hero (i.e. participants 
will type their name and select the day’s date to confirm consent). 
The consent process will identical for participants who are individuals with facial palsy and participants 
who are friends or relatives of someone with facial palsy.  
Written versions of the Participant Information Sheet (physical copy to patients recruited from the 
Oxford Facial Palsy Service and pdf copy sent via email to participants recruited from Facial Palsy UK) and 
Informed Consent (presented on Survey Hero) will be presented to the participants detailing no less 
than: the exact nature of the study; what it will involve for the participant; the implications and 
constraints of the protocol; the known side effects and any risks involved in taking part. 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, without affecting their legal rights, and with no obligation to give the reason for 
withdrawal. 
The participant will be allowed as much time as wished to consider the information, and the opportunity 
to question the Investigator, their GP or other independent parties to decide whether they will 
participate in the study. Written Informed Consent will then be obtained by means of participant dated 
signature and dated signature of the person who presented and obtained the Informed Consent. The 
person who obtained the consent must be suitably qualified and experienced, and have been authorised 
to do so by the Chief/Principal Investigator.  
The electronic copy of the signed Informed Consent will be exported to PDF, printed, signed and dated 
by the Principal investigator and then scanned/emailed to the participant. The original signed form will 
be retained at the study site. 
For participants recruited in OUH clinics a copy of the signed consent form will also go in the medical 
notes. 
7.4. Baseline Assessments 
The following questionnaires will be administered via Survey Hero once participants have read the 
information sheet and met eligibility criteria. This will be completed online remotely for participants 
recruited via Facial Palsy UK (social media, website and mailing list) and online on a laptop during clinic 
for participants attending the Oxford Facial Palsy Service clinic (or remotely via Survey Hero if this is their 
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Primary Objective 
To evaluate the effectiveness of Information and Therapy guides at improving the psychosocial wellbeing 
of people with a diagnosis of facial palsy 
This will be assessed by the change in an individual’s self-report questionnaires before and after a four-
to-six week intervention, using one of six information and therapy guides (the guide that they are given 
will be determined by their responses on a screening questionnaire). The questionnaires used will be: 
Hospital Anxiety and Depression Scale (15): A 14-item scale with two seven-item subscales looking at 
anxiety and depression. A score equal-to-or-lower-than 7 on a subscale falls below the clinical cut-off, a 
score of 8-10 indicates probably clinically significant anxiety or depression, while a score of 11 or more 
indicates clinically significant anxiety or depression. It is well validated in the physical health population, 
excluding somatic symptoms of anxiety and depression that may overlap with symptoms of a physical 
health condition (15). It has been shown to have good test-retest reliability (= .70 to .84; 16). 
FACE-Q Satisfaction with appearance (17): A nine-item scale assessing an individual’s concerns regarding 
their facial appearance. The higher the score, the greater the patient’s dissatisfaction with their 
appearance, with a highest possible score being 32. This measure has been demonstrated to have good 
reliability within a plastic surgery population (17). 
FACE-Q  Psychological function (18): This 11-item scale measures psychological wellbeing using a series 
of positively worded statements, with participants invited to rate how much they agree/disagree with 
each statement. A high score (maximum = 40) indicates greater psychological wellbeing. This measure 
has been validated within a clinical setting and has been shown to have a Cronbach alpha of .96, 
indicating very good internal consistency (18). 
FACE-Q Social functioning (18): Like the FACE-Q psychological function scale, participants are provided 
with a series of positively worded statements. In this scale there are 9 statements and they pertain to 
measuring social functioning. Just as with the psychological function scale, the social functioning scale 
has a Cronbach alpha of .96 and has been shown to have good convergent and discriminant construct 
validity. 
Facial Disability Index (19): A 10-item self-report measure of physical and social function in people with 
facial palsy. Both the physical (=.88) and social (=.83) subscales have been shown to have good internal 
consistency and construct validity (19). Each scale is scored out of 100 (100 = high function). 
This measure of facial function will allow the researchers to control for improvement or decline in facial 
palsy symptoms when assessing the impact of the ITG’s on psychological wellbeing. 
Note: the friends/relatives of participants with facial palsy are not required to complete questionnaires, 
unless they themselves are actively participating in the study (i.e. are trialling the family, friend or 
partner ITG) 
Secondary Objectives 
To evaluate the effectiveness of Information and Therapy guides at improving the psychosocial welling of 
friends and relatives of people with a diagnosis of facial palsy 

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This will be assessed by the change in friend’s/relative’s self-report questionnaires before and after a 
four-to-six week intervention using the information and therapy guide: Facial palsy: Advice for friends, 
relatives and partners of people with facial palsy. 
The outcome measures used will be the Hospital Anxiety and Depression Scale (described above), along 
with the Adult Carer Quality of Life Questionnaire (20). This is a 40-item self-report scale that measures 
the overall quality of life for adult carers. Subscale scores include: support for caring; caring choice; 
caring stress; money matters; personal growth; sense of value; ability to care and carer satisfaction. 
Scores fall on a 0-120 scale, with higher scores indicating better quality of life. 
 
7.5. Subsequent Visits 
 
Participants will be followed up at two different time points: 
After 2-3 weeks: 
Participants will be contacted via email to remind them to complete their current ITG. The will also be 
sent a link to an online questionnaire, pertaining to their ratings of acceptability and usability of the ITG 
(participant satisfaction questionnaire; in line with the Tertiary Objective: To evaluate the acceptability 
and usability of Information and Therapy guides for people with facial palsy and/or their friend or 
relative). 
After 4-6 weeks: 
Participants will be contacted via email to thank them for completing their current ITG. They will be sent 
a link to an online questionnaire, pertaining to their ratings of acceptability and usability of the ITG 
(participant satisfaction questionnaire; in line with the Tertiary Objective: To evaluate the acceptability 
and usability of Information and Therapy guides for people with facial palsy and/or their friend or 
relative). 
Participants will also be sent a web link to re-complete their baseline assessments (in line with the 
Primary and Secondary Objectives). 
Finally, participants with facial palsy will be invited to re-complete the initial ITG screening questionnaire, 
to determine whether they might be eligible to complete a further ITG. If eligible, consent will be sought 
again and the above process will repeat (up to a maximum of 6 times, once for each ITG). Since 
participants who are friends/relatives of people with facial palsy will only have one ITG available to them, 
they will not be provided with the opportunity to complete a further ITG. 
7.6. Discontinuation/Withdrawal of Participants from Study 
 

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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 protocol deviation 
• 
Withdrawal of Consent (withdrawn participants will be replaced and their data will be excluded 
from analysis) 
7.7. Definition of End of Study 
The end of study is the date of the completion of the last ITG (and associated questionnaires) of the last 
participant. 
8. INTERVENTIONS  
The intervention piloted in the current study will be the completion of Information and Therapy Guides.  
We have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy 
and/or their friends or relatives, using evidence-based interventions such as cognitive behavioural 
therapy, social skills training and acceptance and commitment therapy: 
1) Facial palsy: Coping with the early stages. Given the lack of surgical treatment/Botox available in 
the early stages of facial palsy, it was deemed important to produce an ITG focusing on helping 
patients to cope with the early stages of their condition. 
2) Facial palsy: Coping with comments, questions and staring. Due to research (e.g. 6) indicating 
the impact of facial palsy on people’s social skills we decided to produce two guides focussing on 
improving the social skills of this population. This first guide helps people to learn ways of 
managing challenging social situations and to explain their facial palsy to others in a confident 
way. 
3) Facial palsy: Communicating with confidence. The second of the guides focusing on improving 
social skills of people with facial palsy. Given the significant role of facial expression during social 
interactions, and the difficulties that people with facial palsy often having in producing facial 
emotional expressions, this guide helps people with facial palsy to identify ways in which they 
can use verbal and non-verbal communication to communicate in a confident way. 
4) Facial palsy: Managing anxiety. Facial palsy often has a significant impact on an individual’s 
levels of anxiety (5). This guide integrates CBT and acceptance and commitment therapy 
techniques to help patients with facial palsy to manage their anxiety, particularly with regards to 
their appearance and social situations. 
5) Facial palsy: Managing your mood. Nearly 1 in 3 people with facial palsy experience significant 
levels of depression (5). This guide uses principles of CBT to help people with facial palsy to 
manage their mood. 
6) Facial palsy: Building your self-esteem. Low self-esteem is a significant predictor of distress 
amongst individuals with facial palsy (10) and this guide, drawing upon CBT and acceptance and 
commitment therapy, focuses on helping people with facial palsy to build their confidence and 
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7) Facial palsy: Advice for friends, family and partners. At the Oxford Facial Palsy Service we are 
aware that facial palsy not only has an impact on people with facial palsy, but also the wellbeing 
of their friends and family. This guide offers advice to friends and family in order to help them 
look after their own wellbeing, as well as maximise the support that they provide for the person 
with facial palsy. 
This current study aims to pilot the use of these guides in order to assess their effectiveness at improving 
the psychosocial wellbeing of people with facial palsy and their friends and family. Eligible participants 
will complete a set of baseline measures prior to trialling the use of a relevant ITG over a period of four-
to-six weeks. After the four-to-six weeks, participants will re-complete the measures completed at 
baseline, along with a questionnaire assessing the usability and acceptability of the ITGs. 
9. STATISTICS AND ANALYSIS 
9.1. Description of Statistical Methods 
This study will follow a pre-post design and as such will use paired t-tests to observe whether a 
statistically significant change has occurred on each of the outcome measures, for each ITG. Descriptive 
statistics will also be provided (e.g. mean scores on each outcome measure at baseline). 
9.2. The Number of Participants 
We aim to trial the ITGs over a period of two years (May 2019 – May 2021). This will lead to the 
predicted sample sizes of 140 participants (120 with facial palsy, 20 per each of the 6 guides; 20 friends 
and family). This target is based on there being approximately 3000 people who have access to the Facial 
Palsy UK website. Given that approximately 1/3 people with facial palsy experience a significant level of 
distress (5); we hope that our ITGs would be relevant to, and accessible by, around 1000 people. 140 is 
therefore a conservative estimate of the number of participants that we will be able to recruit. As this is 
an initial feasibility study, a power analysis was not conducted for the purposes of this study. 
9.3. Analysis of Outcome Measures 
A pre-post design will be used to determine whether the use of ITGs lead to a significant improvement in 
the psychosocial wellbeing of people with facial palsy and or their friends and relatives, as measured by 
the Hospital Anxiety and Depression Scale, Face-Q – Social function (people with facial palsy only), Face-
Q – Psychological function (people with facial palsy only), Face-Q – Appearance-related psychosocial 
distress (people with facial palsy only) and the Facial Disability Index (people with facial palsy only). This 
change will be measured for each individual ITG, using paired-samples t-tests. The Facial Disability Index 
can also be used to control for improvement in facial palsy symptoms, when assessing the impact of ITGs 
on scores on measures of psychological wellbeing. In the instance of a significant change in facial palsy 
symptoms being observed, separate ANCOVAs will be used, with Facial Disability Index score being used 
as a covariate and scores on individual measures of psychosocial wellbeing serving as within-subjects 
factors. 
10. DATA MANAGEMENT 

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10.1. 
Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
10.2. 
Data Recording and Record Keeping 
 
None of the study documents besides the identification log (and consent forms) will contain any 
identifiable data.  
Participants are assigned a study ID and this will be used on all online questionnaires, study documents 
and the database which will contain no identifiable data, they will only be identifiable on the ID log 
linking the ID number and their personal information.  
The log of study IDs will be kept electronically and separately from participant data and will only be 
accessible by members of the research team.  
Electronic copies of consent forms will be kept in password protected file, separate to completed 
questionnaires, which will be kept securely and separately in a password protected file.  
Hard copies of consent forms will be kept in the Study Master File, separate to completed 
questionnaires, which will be kept securely and separately to the Study Master File. These will be in a 
locked filing cabinet in the Russell Cairns Unit, Level 3 West Wing, John Radcliffe Hospital. 
Questionnaire data will be transferred to an excel sheet and SPSS datasheet. 
These databases, and ID log, will be kept separately on a password protected database/spreadsheet 
stored on NHS servers. 
The database will be tested at regular intervals to ensure accuracy. This will be done by the lead 
researcher selecting one participant at random, to ensure that the data has been entered accurately. 
The Study Master File and anonymised research data will be kept for 5 years.  
Contact details for parents who’d like to receive a copy of the results will be stored for 12 months and 
kept securely and separately to any anonymised research data.  
Survey Hero is GDPR compliant. 
11. QUALITY ASSURANCE PROCEDURES 
The study may be monitored, or audited in accordance with the current approved protocol, GCP, 
relevant regulations and standard operating procedures. 
12. ETHICAL AND REGULATORY CONSIDERATIONS 
12.1. 
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.  
12.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
12.3. 
Approvals 
The protocol, informed consent form, participant information sheet and any proposed advertising 
material will be submitted to an appropriate Research Ethics Committee (REC), and HRA for written 
approval. 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
12.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the 
REC Committee, HRA (where required) host organisation and Sponsor. In addition, an End of Study 
notification and final report will be submitted to the same parties. 
12.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be 
identified only by a participant ID number on all study documents and any electronic database.  All 
documents will be stored securely and only accessible by study staff and authorised personnel. The study 
will comply with the Data Protection Act, which requires data to be anonymised as soon as it is practical 
to do so. No identifiable data will be published. 
12.6. 
Expenses and Benefits 
Since data collection will take place at routine clinic appointment or via email/web-based survey, travel 
expenses will not be reimbursed. 
12.7. 
Other Ethical Considerations 
The questionnaires used in this study include topics that may be sensitive for certain participants. For 
example, certain questions ask about the participant’s mood and anxiety. In particular, the Hospital 
Anxiety and Depression Scale will indicate whether participants are experiencing clinically significant 
anxiety and/or depression. If participants report clinically significant anxiety and/or depression, then the 
lead researcher will contact the participant on the telephone (or talk to the participant if meeting face-
to-face in clinic) to inform them of that their score is indicative of elevated levels of anxiety and/or 
depression and that we recommend that they contact their GP to discuss this further. We will also 
provide emergency/out of hours information (if it is out of hours and your GP surgery is closed, dial 111 if 
they wish to speak with a GP. If it is an emergency situation call 999.) 

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The consent form contains information for participants informing them that the research team will not 
be providing psychological treatment for participants, beyond the use of ITGs, and as such participants 
should contact their GP, rather than the research team, if they are concerned about their psychological 
wellbeing.  
13. FINANCE AND INSURANCE 
13.1. 
Funding 
This project is funded by the VTCT foundation. The VTCT Foundation awarded £61,383.88 for use over a 
30 month period. This grant covers the salary for the lead researcher (0.4 wte), as well as research costs, 
design and printing costs and conference/travel costs. 
13.2. 
Insurance 
NHS bodies are legally liable for the negligent acts and omissions of their employees. If you are harmed 
whilst taking part in a clinical research study as a result of negligence on the part of a member of the 
study team this liability cover would apply. 
Non-negligent harm is not covered by the NHS indemnity scheme. The Oxford University Hospitals NHS 
Foundation Trust, therefore, cannot agree in advance to pay compensation in these circumstances. 
In exceptional circumstances an ex-gratia payment may be offered. 
14. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and 
any other publications arising from the study.  Authors will acknowledge that the study was funded by 
the VTCT Foundation. Authorship will be determined in accordance with the ICMJE guidelines and other 
contributors will be acknowledged. 
 
 

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15. REFERENCES 
  
 
1) Martyn CN, Hughes RA. Epidemiology of peripheral neuropathy. J Neurol Neurosurg 
Psychiatry. 1997;62(4):310. 
2) Peitersen E. Bell’s Palsy: The Spontaneous Course of 2,500 Peripheral Facial Nerve Palsies 
of Different Etiologies. Acta Otolaryngol Suppl, 2002;122(7), p4-30.  
3) Hultcrantz M. Rehabilitation of Bells palsy from a multi-team perspective. Acta Oto-
Laryngol. 2016. 
4) Shindo M. Management of facial nerve paralysis. Otolaryngol Clin North Am. 
1999;32(5):945–64. 
5) Fu L, Bundy C, Sadiq SA. Psychological distress in people with disfigurement from facial 
palsy. Eye. 2011;25(10):1322-1326. 
6) Bradbury ET, Simons W, Sanders R. Psychological and social factors in reconstructive 
surgery for hemi-facial palsy. J Plast Reconstr Aesthet Surg. 2006;59(3):272–8.  
7) Coulson SE, O’Dwyer NJ, Adams RD, Croxson GR. Expression of emotion and quality of 
life after facial nerve paralysis. Otol Neurotol. 2004;25(6):1014. 
8) VanSwearingen JM, Cohn JF, Bajaj-Luthra A. Specific Impairment of Smiling Increases the 
Severity of Depressive Symptoms in Patients with Facial Neuromuscular Disorders. Off J 
Int Soc Plast Surg. 1999;23(6):416–23. 
9) McManus S, Bebbington P, Jenkins R, Brugha T. Adult psychiatric morbidity survey: 
survey of mental health and wellbeing, England, 2014. Leeds: NHS Digital 
10) Cross T, E. Sheard C, Garrud P, Nikolopoulos TP, O'Donoghue GM. Impact of facial 
paralysis on patients with acoustic neuroma. The Laryngoscope. 2000 Sep;110(9):1539-
42. 
11) Schulz R, Sherwood PR. Physical and mental health effects of family caregiving. Journal of 
Social Work Education. 2008 Sep 1;44(sup3):105-13. 
12) Kilshaw AD, Holmes WJ, Matteucci P. Funding in facial palsy. Journal of plastic, 
reconstructive & aesthetic surgery: JPRAS. 2016 Nov;69(11):1526. 
13) Hamlet C, Rumsey N, Williamson H, Johnson K, Nduka C. Consensus research priorities 
for facial palsy: A Delphi survey of patients, carers, clinicians and researchers. Journal of 
Plastic, Reconstructive & Aesthetic Surgery. 2018 Sep 1. 
14) Muftin Z, Thompson AR. A systematic review of self-help for disfigurement: 
Effectiveness, usability, and acceptability. Body Image. 2013 Sep 1;10(4):442-50. 
15) Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta psychiatrica 
scandinavica. 1983 Jun 1;67(6):361-70. 
16) Herrmann C. International experiences with the Hospital Anxiety and Depression Scale-a 
review of validation data and clinical results. Journal of psychosomatic research. 1997 
Jan 1;42(1):17-41. 
17) Klassen AF, Cano SJ, Alderman A, East C, Badia L, Baker SB, Robson S, Pusic AL. Self-
report scales to measure expectations and appearance-related psychosocial distress in 
patients seeking cosmetic treatments. Aesthetic surgery journal. 2016 May 
24;36(9):1068-78. 
18) Klassen AF, Cano SJ, Schwitzer J, Scott A, Pusic AL. FACE-Q scales for health-related 
quality of life, early life impact and satisfaction with outcomes and decision to have 
treatment: development and validation. Plast Reconstr Surg. 2015;135(2):375-86. 
19) VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a 

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disability assessment instrument for disorders of the facial neuromuscular system. 
Physical therapy. 1996 Dec 1;76(12):1288-98. 
20) Elwick H, Joseph S, Becker S, Becker F. Manual for the adult carer quality of life 
questionnaire (AC-QoL). London UK: The Princess Royal Trust for Carers. 2010. 
 
 

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16. APPENDIX A:  AMENDMENT HISTORY 
 
Amendment 
No. 
Protocol 
Version 
No. 
Date 
issued 
Author(s) of changes 
Details of Changes made 
 
 
 
 
 
 
List details of all protocol amendments here whenever a new version of the protocol is produced.  This is 
not necessary prior to initial REC submission. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX B – FLOW CHART 
 
 
Recruitment 
Online or in clinic 
Informed consent 
Provided online via Survey Hero 
Screening 
Carried out online via Survey 
Hero 
Not eligible 
Individual is 
thanked for their 
interest in the 
study and the 
reason for their 
ineligibility is 
explained to them 
If eligible 
Completion of baseline questionnaires via Survey 
Hero & participant is sent ITG 
2-3 weeks 
Participant is sent email invite to complete 
satisfaction questionnaire via Survey Hero 
4-6 weeks 
Participant is sent email invite to 
re-complete baseline 
questionnaires and satisfaction 
questionnaire via Survey Hero 
Participant is friend, 
family member or 
partner 
Participant is thanked 
for their completion 
of the study 
 
Participant with facial palsy 
Participant is provided the screening questionnaire again to see if 
they are eligible to complete another ITG. If they are not eligible, 
choose not to complete another ITG or have completed all the ITGs 
then they will be thanked for their completion of the study