Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03943953
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2019-05-08
Brief Title:
Self-guided Psychosocial Intervention for Facial Palsy
Sponsor:
Oxford University Hospitals NHS Trust
Organization:
Oxford University Hospitals NHS Trust
Study Overview
Official Title:
A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Facial palsy affects between 23 to 35 people per 100000 As well as affecting an individuals 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 individuals 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 faces 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 andor 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 andor 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
Facial palsy has been shown to have a significant impact on an individuals 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 faces 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 andor 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 andor 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 andor their friends and relatives all eligible participants will receive the intervention ie 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 eg 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 UKsocial 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 researchers 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 carersrelatives 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 ie 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
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 eg 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 UKsocial 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 researchers 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 carersrelatives 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None