A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- FACE-Q Social Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Facial Palsy - Trial of ITG
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.
干预措施: Information and Therapy Guides (Behavioral)
结局指标
主要结局
FACE-Q Social Function
时间窗: 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)
时间窗: 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 Psychological Function
时间窗: 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 Appearance-Related Psychosocial Distress
时间窗: 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
时间窗: 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.
FACE-Q Psychological Function
时间窗: 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 Social Function
时间窗: 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.
Facial Disability Index (Social Function)
时间窗: 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.
FACE-Q Appearance-Related Psychosocial Distress
时间窗: 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.
Hospital Anxiety and Depression Scale
时间窗: 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.
次要结局
- Adult Carer Quality of Life Questionnaire(Time 2: 4-6 week follow-up)
- Adult Carer Quality of Life Questionnaire(Time 1: Baseline)
研究者
Matthew Hotton
Primary Investigator
Oxford University Hospitals NHS Trust