Facial PalsyNCT03943953
Self-guided Psychosocial Intervention for Facial Palsy
A study testing Information and Therapy Guides in people with Facial Palsy, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Facial palsy affects between 23 to 35 people per 100,000. As well as affecting an individual's appearance, it also can lead to difficulties with: eating, drinking, speaking, eyelid closure, pain and taste. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Palsy
- What is being tested?
- Information and Therapy Guides
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2019to 5 May 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Participant who is a friend, family member or partner of someone with facial palsy:
Show all 10Show fewer
- 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
Who cannot join
- 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.
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
Facial palsy affects between 23 to 35 people per 100,000. As well as affecting an individual's appearance, it also can lead to difficulties with: eating, drinking, speaking, eyelid closure, pain and taste.
Facial palsy has been shown to have a significant impact on an individual's psychological wellbeing, including issues with anxiety, depression and low self-esteem. These elevated levels of distress have been thought to be partly 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.
Read more
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. With this in mind, the investigators have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. The investigators have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:
- Facial palsy: Coping with the early stages.
- Facial palsy: Coping with comments, questions and staring.
- Facial palsy: Communicating with confidence.
- Facial palsy: Managing anxiety.
- Facial palsy: Managing your mood.
- Facial palsy: Building your self-esteem.
- Facial palsy: Advice for friends, family and partners.
The investigators aim to evaluate the effectiveness, usability and acceptability of these guides to people with facial palsy and/or their friends, family and partners, by piloting their use over a 4-6 week period. Assessment of psychosocial wellbeing will be carried out before and after the 4-6 week period, while participants will be invited to provide usability and acceptability feedback on the guides after the 4-6 week period.
Read the detailed description
Given that this study represents an initial pilot of the use of self-guided information and therapy guides 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:
- Face-to-face of recruitment of OUH NHS patients during clinics at the Oxford Facial Palsy Service
- 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 be invited to provide written consent. Participants recruited through the Oxford Facial Palsy Service will proved written consent via Survey Hero, either in clinic or remotely online at a later if they wish for longer time to consider their involvement in the study. Participants recruited through Facial Palsy UK/social media will provide written consent via Survey Hero.
Once participants have provided consent, they will be provided with an online screening questionnaire (in order to check for eligibility). Participants recruited in Oxford Facial Palsy Service clinics will complete the screening questionnaire on the researcher's laptop. 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. Participants recruited on social media will be emailed a link to the screening questionnaire.
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. The Facial Disability Index will allow for control of improvement in facial palsy symptoms over time.
Friends, relatives and partners: Hospital Anxiety and Depression Scale and Adult Carer Quality of Life Questionnaire.
Like the screening questionnaires, written consent and baseline questionnaires will be completed online.
Eligible participants will then be administered the relevant self-guided information and therapy guide. For eligible carers/relatives this will be the guide 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.
Participants will then utilise the guide 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 guide 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 guides (participant satisfaction questionnaire).
At the end of the four-to-six week period, participants will be re-administered the baseline questionnaires, along with a questionnaire designed for the purpose of the current study measuring the participants' ratings of acceptability and usability of the guides (participant satisfaction questionnaire). 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 guide. 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 guide over a second four-to-six week period (followed by the same follow-up assessments as followed the first guide). This process will occur up to a maximum of six times (reflecting the potential for a participant to trial all six guides). If they do not wish to complete further guides then the participant will be thanked for their involvement in the study and their involvement will be registered as 'complete'.
Friends, relatives and partners of people with facial palsy will only be required to complete pre and post questionnaires if they are actively involved in the study due to completing the friend, relative or partner ITG. Likewise, individuals with facial palsy are not required to complete questionnaires if they are not actively involved in the study (i.e. not trialing and ITG), but their friend or relative is.
The investigators aim to trial the guides over a period of one year (May 2019 - May 2020). This will lead to the predicted sample size 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 one-third of people with facial palsy experience a significant level of distress; the investigators hope that our guides would be relevant to, and accessible by, around 1000 people. 140 is therefore a conservative estimate of the number of participants that the investigators will be able to recruit.
Participants recruited from OUH NHS Foundation trust will be provided with an information sheet during their clinic appointment with the Oxford Facial Palsy Service. Written consent will be obtained in the clinic by a member of the research team.
Participants recruited from social media will be provided with an information sheet via email and will provide written consent online.
- Conditions
- Facial Palsy
- Being tested
- Information and Therapy Guides
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information and Therapy GuidesBehavioural
We have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. We have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:
- Facial palsy: Coping with the early stages.
- Facial palsy: Coping with comments, questions and staring.
- Facial palsy: Communicating with confidence.
- Facial palsy: Managing anxiety.
- Facial palsy: Managing your mood.
- Facial palsy: Building your self-esteem.
- Facial palsy: Advice for friends, family and partners.
| Study group | Role | What they receive |
|---|---|---|
| Facial Palsy - Trial of ITG | Experimental | In this arm of the trial individuals with facial palsy will trial the use of information and therapy guides over a 4-6 week period. They will complete measures at the start and end of this period. Receives: Behavioral: Information and Therapy Guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACE-Q Psychological Function
This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 1: Baseline
FACE-Q Psychological Function
This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 2: 4-6 week follow-up
FACE-Q Social Function
In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 1: Baseline
FACE-Q Social Function
In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 2: 4-6 week follow-up
Facial Disability Index (Social Function)
A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function).
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 1: Baseline
Facial Disability Index (Social Function)
A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function).
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 2: 4-6 week follow-up
FACE-Q Appearance-Related Psychosocial Distress
An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 1: Baseline
FACE-Q Appearance-Related Psychosocial Distress
An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance.
As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Measured: Time 2: 4-6 week follow-up
Hospital Anxiety and Depression Scale
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. Scores range from 0-52, with a higher score indicating higher severity.
As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.
Measured: Time 1: Baseline
Hospital Anxiety and Depression Scale
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. Scores range from 0-52, with a higher score indicating higher severity.
As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.
Measured: Time 2: 4-6 week follow-up
Secondary outcomes (2)
Adult Carer Quality of Life Questionnaire
40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life
Measured: Time 1: Baseline
Adult Carer Quality of Life Questionnaire
40 item questionnaire assessing carer quality of life. Possible scores range from 0-120, with higher scores indicating higher quality of life
Measured: Time 2: 4-6 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start15 Aug 2019
- Primary completion5 May 2021
- Study completion5 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Facial PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One single group will be trialling a new self-guided psychological intervention
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Hotton, Oxford University Hospitals NHS Trust
- Investigators
- Matthew Hotton, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943953
- Sponsor's protocol ID
- 14110
- Status last verified
- Aug 2022
- First submitted
- 8 May 2019
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make data available
Publications
Fu L, Bundy C, Sadiq SA. Psychological distress in people with disfigurement from facial palsy. Eye (Lond). 2011 Oct;25(10):1322-6. doi: 10.1038/eye.2011.158. Epub 2011 Jul 1.
PubMed 21720412Coulson SE, O'dwyer NJ, Adams RD, Croxson GR. Expression of emotion and quality of life after facial nerve paralysis. Otol Neurotol. 2004 Nov;25(6):1014-9. doi: 10.1097/00129492-200411000-00026.
PubMed 15547436Muftin Z, Thompson AR. A systematic review of self-help for disfigurement: effectiveness, usability, and acceptability. Body Image. 2013 Sep;10(4):442-50. doi: 10.1016/j.bodyim.2013.07.005. Epub 2013 Aug 17.
PubMed 23962642Martyn CN, Hughes RA. Epidemiology of peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1997 Apr;62(4):310-8. doi: 10.1136/jnnp.62.4.310. No abstract available.
PubMed 9120441Hultcrantz M. Rehabilitation of Bells' palsy from a multi-team perspective. Acta Otolaryngol. 2016;136(4):363-7. doi: 10.3109/00016489.2015.1116124. Epub 2015 Dec 4.
PubMed 26634395Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Klassen 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. Aesthet Surg J. 2016 Oct;36(9):1068-78. doi: 10.1093/asj/sjw078. Epub 2016 May 24.
PubMed 27222106VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300. doi: 10.1093/ptj/76.12.1288.
PubMed 8959998Hotton M, Johnson D, Kilcoyne S, Dalton L. Evaluating the effectiveness and acceptability of information and therapy guides for improving the psychosocial well-being of people with facial palsy. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3356-3364. doi: 10.1016/j.bjps.2022.04.022. Epub 2022 Apr 25.
PubMed 35623976
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
- ClinicalTrials.gov ID
- NCT03943953
- Acronym / sponsor ID
- 14110
- Conditions
- Facial Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Facial palsy affects between 23 to 35 people per 100,000. As well as affecting an individual's appearance, it also can lead to difficulties with: eating, drinking, speaking, eyelid closure, pain and taste.
Facial palsy has been shown to have a significant impact on an individual's psychological wellbeing, including issues with anxiety, depression and low self-esteem. These elevated levels of distress have been thought to be partly 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.
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. With this in mind, the investigators have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. The investigators have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:
- Facial palsy: Coping with the early stages.
- Facial palsy: Coping with comments, questions and staring.
- Facial palsy: Communicating with confidence.
- Facial palsy: Managing anxiety.
- Facial palsy: Managing your mood.
- Facial palsy: Building your self-esteem.
- Facial palsy: Advice for friends, family and partners.
The investigators aim to evaluate the effectiveness, usability and acceptability of these guides to people with facial palsy and/or their friends, family and partners, by piloting their use over a 4-6 week period. Assessment of psychosocial wellbeing will be carried out before and after the 4-6 week period, while participants will be invited to provide usability and acceptability feedback on the guides after the 4-6 week period.
Detailed description
Given that this study represents an initial pilot of the use of self-guided information and therapy guides 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:
- Face-to-face of recruitment of OUH NHS patients during clinics at the Oxford Facial Palsy Service
- 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 be invited to provide written consent. Participants recruited through the Oxford Facial Palsy Service will proved written consent via Survey Hero, either in clinic or remotely online at a later if they wish for longer time to consider their involvement in the study. Participants recruited through Facial Palsy UK/social media will provide written consent via Survey Hero.
Once participants have provided consent, they will be provided with an online screening questionnaire (in order to check for eligibility). Participants recruited in Oxford Facial Palsy Service clinics will complete the screening questionnaire on the researcher's laptop. 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. Participants recruited on social media will be emailed a link to the screening questionnaire.
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. The Facial Disability Index will allow for control of improvement in facial palsy symptoms over time.
Friends, relatives and partners: Hospital Anxiety and Depression Scale and Adult Carer Quality of Life Questionnaire.
Like the screening questionnaires, written consent and baseline questionnaires will be completed online.
Eligible participants will then be administered the relevant self-guided information and therapy guide. For eligible carers/relatives this will be the guide 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.
Participants will then utilise the guide 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 guide 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 guides (participant satisfaction questionnaire).
At the end of the four-to-six week period, participants will be re-administered the baseline questionnaires, along with a questionnaire designed for the purpose of the current study measuring the participants' ratings of acceptability and usability of the guides (participant satisfaction questionnaire). 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 guide. 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 guide over a second four-to-six week period (followed by the same follow-up assessments as followed the first guide). This process will occur up to a maximum of six times (reflecting the potential for a participant to trial all six guides). If they do not wish to complete further guides then the participant will be thanked for their involvement in the study and their involvement will be registered as 'complete'.
Friends, relatives and partners of people with facial palsy will only be required to complete pre and post questionnaires if they are actively involved in the study due to completing the friend, relative or partner ITG. Likewise, individuals with facial palsy are not required to complete questionnaires if they are not actively involved in the study (i.e. not trialing and ITG), but their friend or relative is.
The investigators aim to trial the guides over a period of one year (May 2019 - May 2020). This will lead to the predicted sample size 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 one-third of people with facial palsy experience a significant level of distress; the investigators hope that our guides would be relevant to, and accessible by, around 1000 people. 140 is therefore a conservative estimate of the number of participants that the investigators will be able to recruit.
Participants recruited from OUH NHS Foundation trust will be provided with an information sheet during their clinic appointment with the Oxford Facial Palsy Service. Written consent will be obtained in the clinic by a member of the research team.
Participants recruited from social media will be provided with an information sheet via email and will provide written consent online.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One single group will be trialling a new self-guided psychological intervention
| Arm | Type | Receives |
|---|---|---|
| Facial Palsy - Trial of ITG | Experimental | Behavioral: Information and Therapy GuidesIn this arm of the trial individuals with facial palsy will trial the use of information and therapy guides over a 4-6 week period. They will complete measures at the start and end of this period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Participant is willing and able to give informed consent for participation in the study.
Key exclusion criteria (10 listed)
- 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.
- 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).
- The participant is not in within the target age range (e.g. under the age of 18 years).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information and Therapy GuidesWe have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. We have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy: 1. Facial palsy: Coping with the early stages. 2. Facial palsy: Coping with comments, questions and staring. 3. Facial palsy: Communicating with confidence. 4. Facial palsy: Managing anxiety. 5. Facial palsy: Managing your mood. 6. Facial palsy: Building your self-esteem. 7. Facial palsy: Advice for friends, family and partners. | Behavioural | Facial Palsy - Trial of ITG |
Primary outcome
FACE-Q Psychological Function
Time frame: Time 1: Baseline
This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
FACE-Q Psychological Function
Time frame: Time 2: 4-6 week follow-up
This 10-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. There is a minimum score of 10 and a maximum score of 40. Scores are Rasch transformed to a 0-100 scale. A high score indicates greater psychological wellbeing. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
FACE-Q Social Function
Time frame: Time 1: Baseline
In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
FACE-Q Social Function
Time frame: Time 2: 4-6 week follow-up
In this scale there are 8 statements pertaining to measuring social functioning. Scores on this scale range from 8 to 32, with scores Rasch transformed to a 0-100 scale. Higher scores indicate better social function. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Facial Disability Index (Social Function)
Time frame: Time 1: Baseline
A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function). As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Facial Disability Index (Social Function)
Time frame: Time 2: 4-6 week follow-up
A 5-item self-report measure of social function in people with facial palsy. The scale is scored out of 100 (100 = high function). As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
FACE-Q Appearance-Related Psychosocial Distress
Time frame: Time 1: Baseline
An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
FACE-Q Appearance-Related Psychosocial Distress
Time frame: Time 2: 4-6 week follow-up
An eight-item scale assessing an individual's concerns regarding their facial appearance on a scale of 8-32, which is then Rasch transformed to a 0-100 scale. The higher the score, the greater the patient's dissatisfaction with their appearance. As some participants were eligible to trial multiple guides, some participants contributed multiple data points.
Hospital Anxiety and Depression Scale
Time frame: Time 1: Baseline
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. Scores range from 0-52, with a higher score indicating higher severity. As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.
Hospital Anxiety and Depression Scale
Time frame: Time 2: 4-6 week follow-up
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. Scores range from 0-52, with a higher score indicating higher severity. As some participants with facial palsy were eligible to trial multiple guides, some participants with facial palsy contributed multiple data points.
2 secondary outcomes
Adult Carer Quality of Life Questionnaire
Time frame: Time 1: Baseline
Adult Carer Quality of Life Questionnaire
Time frame: Time 2: 4-6 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21720412Fu L, Bundy C, Sadiq SA. Psychological distress in people with disfigurement from facial palsy. Eye (Lond). 2011 Oct;25(10):1322-6. doi: 10.1038/eye.2011.158. Epub 2011 Jul 1.
- Background: PubMed 15547436Coulson SE, O'dwyer NJ, Adams RD, Croxson GR. Expression of emotion and quality of life after facial nerve paralysis. Otol Neurotol. 2004 Nov;25(6):1014-9. doi: 10.1097/00129492-200411000-00026.
- Background: PubMed 23962642Muftin Z, Thompson AR. A systematic review of self-help for disfigurement: effectiveness, usability, and acceptability. Body Image. 2013 Sep;10(4):442-50. doi: 10.1016/j.bodyim.2013.07.005. Epub 2013 Aug 17.
- Background: PubMed 9120441Martyn CN, Hughes RA. Epidemiology of peripheral neuropathy. J Neurol Neurosurg Psychiatry. 1997 Apr;62(4):310-8. doi: 10.1136/jnnp.62.4.310. No abstract available.
- Background: PubMed 26634395Hultcrantz M. Rehabilitation of Bells' palsy from a multi-team perspective. Acta Otolaryngol. 2016;136(4):363-7. doi: 10.3109/00016489.2015.1116124. Epub 2015 Dec 4.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 27222106Klassen 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. Aesthet Surg J. 2016 Oct;36(9):1068-78. doi: 10.1093/asj/sjw078. Epub 2016 May 24.
- Background: PubMed 8959998VanSwearingen JM, Brach JS. The Facial Disability Index: reliability and validity of a disability assessment instrument for disorders of the facial neuromuscular system. Phys Ther. 1996 Dec;76(12):1288-98; discussion 1298-300. doi: 10.1093/ptj/76.12.1288.
- Derived from this study: PubMed 35623976Hotton M, Johnson D, Kilcoyne S, Dalton L. Evaluating the effectiveness and acceptability of information and therapy guides for improving the psychosocial well-being of people with facial palsy. J Plast Reconstr Aesthet Surg. 2022 Sep;75(9):3356-3364. doi: 10.1016/j.bjps.2022.04.022. Epub 2022 Apr 25.
- Individual participant dataSharing planned: No. No plan to make data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Hotton principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information and Therapy Guides in people with Facial Palsy, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACE-Q Psychological Function (time frame: Time 1: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943953, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.