Facial Palsy Clinical Trial
Official title:
A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
NCT number | NCT03943953 |
Other study ID # | 14110 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2019 |
Est. completion date | May 5, 2021 |
Verified date | August 2022 |
Source | Oxford University Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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: 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. 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.
Status | Completed |
Enrollment | 97 |
Est. completion date | May 5, 2021 |
Est. primary completion date | May 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 Exclusion Criteria: 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: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | John Radcliffe Hospital | Oxford | Oxon |
Lead Sponsor | Collaborator |
---|---|
Oxford University Hospitals NHS Trust |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Time 1: Baseline | |
Primary | 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. |
Time 2: 4-6 week follow-up | |
Primary | 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. |
Time 1: Baseline | |
Primary | 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. |
Time 2: 4-6 week follow-up | |
Primary | 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. |
Time 1: Baseline | |
Primary | 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. |
Time 2: 4-6 week follow-up | |
Primary | 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. |
Time 1: Baseline | |
Primary | 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. |
Time 2: 4-6 week follow-up | |
Primary | 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. |
Time 1: Baseline | |
Primary | 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. |
Time 2: 4-6 week follow-up | |
Secondary | 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 | Time 1: Baseline | |
Secondary | 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 | Time 2: 4-6 week follow-up |
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