[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602707":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":32,"armGroups":40,"interventions":53,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":87,"collaborators":32,"id":89,"slug":32,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":32,"eligibilityCriteria":93,"healthyVolunteers":90,"sex":94,"minAge":95,"maxAge":32,"enrollmentInfo":96,"targetDuration":32,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":109,"whyStopped":32,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":32},[9,13,15,17,20,21,22,25,26,27,30,31],{"measure":10,"description":11,"timeFrame":12},"Facial Clinimetric Evaluation Scale (FaCE)","15 items rated on a 5-point Likert scale where 1 corresponds to the lowest level of function and 5 corresponds to the highest level of function. The items are categorized into 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function with each domain being scored out of a total of 100 where 0 is the worst possible score to 100 being the best. The mean derived from all domains will determine the total score (out of 100).","Baseline",{"measure":10,"description":11,"timeFrame":14},"Week 8",{"measure":10,"description":11,"timeFrame":16},"Week 16",{"measure":18,"description":19,"timeFrame":12},"Hospital Anxiety and Depression Scale (HADS)","14-item questionnaire measuring anxiety and depression levels. Total score range is 0-21 with higher score indicating higher likelihood of anxiety\u002Fdepression.",{"measure":18,"description":19,"timeFrame":14},{"measure":18,"description":19,"timeFrame":16},{"measure":23,"description":24,"timeFrame":12},"Synkinesis Assessment Questionnaire (SAQ)","9-item questionnaire assessing patient perceived severity of synkinesis using a five-point scale. Total score ranges from 20-100. High score means a greater perceived severity of synkinesis symptoms, low score means less perceived severity of synkinesis symptoms.",{"measure":23,"description":24,"timeFrame":14},{"measure":23,"description":24,"timeFrame":16},{"measure":28,"description":29,"timeFrame":12},"Mindfulness Attention Awareness Scale (MAAS)","15-item questionnaire to assess a core characteristic of mindfulness and how much you experience mindfulness in everyday life, not just during meditation. Total score range is 15-90. High score indicates more mindful, more likely to be aware of your thoughts, feelings, and sensations in the present moment. Low score indicates less mindful, more distracted or on \"automatic pilot.\"",{"measure":28,"description":29,"timeFrame":14},{"measure":28,"description":29,"timeFrame":16},null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE","This study will utilize a prospective randomized two-arm intervention design to assess the effects of mindfulness on patients with non-flaccid facial paralysis. Patients will either be randomized to the normal standard of care Physical Therapy intervention for 8 weeks, or Physical therapy and 8 sessions of mindfulness for 8 weeks. The patients randomized to the mindfulness intervention will undergo 8 sessions of mindfulness prior to completing their physical therapy session. These mindfulness interventions will be recordings administered through a phone or computer, through mindfulsynkinesis.com. Mindfulness scripts were created using Open Network materials and verified by a medical doctor and physical therapist trained in Mindfulness Based Stress Reduction. Each mindfulness session will take 5-10 minutes and will be completed once weekly, immediately prior to their physical therapy sessions.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Mindfulness Sessions","EXPERIMENTAL","8 sessions of mindfulness prior to completing their physical therapy session",[46],"Behavioral: Mindfulness Sessions",{"label":48,"type":49,"description":50,"interventionNames":51},"No Mindfulness Sessions","ACTIVE_COMPARATOR","Standard of care no mindfulness sessions",[52],"Behavioral: No Mindfulness Sessions",[54,58],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":32},"BEHAVIORAL","8 sessions of mindfulness prior to completing their physical therapy session. Each mindfulness session will take 5-10 minutes and will be completed once weekly, immediately prior to their physical therapy sessions. Mindfulness prompts will focus on self-reflection, relaxation, body scanning and being present.",[42],{"type":55,"name":48,"description":59,"armGroupLabels":60,"otherNames":32},"Standard of care physical therapy without mindfulness sessions.",[48],[62],{"name":63,"affiliation":64,"role":65},"Katherine Gossett, MD","Atrium Health Wake Forest Baptist","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":32,"email":71},"Joann Bluj, MD","CONTACT","570-952-4527","joann.bluj@advocatehealth.org",[73],{"facility":64,"status":32,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Winston-Salem","North Carolina","27157","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-80.24422,36.09986,{"lat":83,"lon":82},[86],{"name":68,"role":69,"phone":70,"phoneExt":32,"email":71},{"type":88,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100602707",false,"NCT07127016","Mindfulness in Nonflaccid Facial Paralysis","Inclusion Criteria:\n\n\\- Diagnosed with non-flaccid facial paralysis (NFFP) due to Bell's Palsy, Ramsay Hunt syndrome, Lyme disease, or post-acoustic neuroma resection, at least 8 months from the initial diagnosis\n\nExclusion Criteria:\n\n* Received treatments such as botox or physical therapy for facial paralysis\n* History of malignancy or facial surgery","ALL","18 Years",{"count":97,"type":98},24,"ESTIMATED","INTERVENTIONAL",[101],"NA","The purpose of this study is to learn more about how mindfulness techniques can help reduce anxiety, depression and body image disturbance as well as improve synkinesis in individuals with non-flaccid facial paralysis.",[104],"Facial Paralysis",[106,107,108],"non-flaccid facial paralysis","synkinesis","mindfulness","NOT_YET_RECRUITING","2026-06-29",{"date":112,"type":113},"2026-06-30","ACTUAL",{"date":115,"type":98},"2026-07",{"date":117,"type":98},"2027-01",{"name":5,"class":6},1]