CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
Information and Therapy Guidesbehavioral
Likely dose
Not stated in record
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Search/NCT03943953
NCT03943953N/ACompleted

A Pilot Study Evaluating the Effectiveness of Information and Therapy Guides for Improving the Psychosocial Wellbeing of People With Facial Palsy.

Oxford University Hospitals NHS Trust·interventional·Posted May 9, 2019·Updated Jul 10, 2023

In Brief

A clinical study evaluating Information and Therapy Guides for Facial Palsy. Completed, enrolled 97 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFacial Palsy
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 9, 2019
Enrollment StartAug 15, 2019
Primary CompletionMay 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.1 years ago

Interventions

Information and Therapy Guidesbehavioral

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: 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.