Mindfulness for Facial Palsy

JB
Overseen ByJoann Bluj, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether mindfulness techniques can improve emotional well-being and muscle control issues, such as synkinesis (unwanted facial movements), in individuals with non-flaccid facial paralysis. Participants will either engage in mindfulness sessions or continue with their standard care to determine if mindfulness makes a difference. Suitable candidates have experienced non-flaccid facial paralysis from conditions like Bell's Palsy or Lyme disease for at least 8 months and have not used physical therapy or treatments like Botox. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing facial paralysis symptoms.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that mindfulness techniques are safe for individuals with facial paralysis?

Research shows that mindfulness techniques are generally safe for participants. As a non-medication treatment, mindfulness often results in fewer side effects. Studies have found that mindfulness can reduce anxiety and depression and improve body image. These outcomes benefit those with facial paralysis. Since mindfulness is widely used for stress and mental health issues, its safety is well-established. Participants in mindfulness sessions typically feel comfortable and tolerate them well. No major negative effects have been reported in treatments for facial paralysis.12345

Why are researchers excited about this trial?

Unlike the standard treatments for facial palsy, which often include physical therapy and sometimes surgery, mindfulness sessions offer a unique, non-invasive approach. Researchers are excited about this method because mindfulness can potentially enhance emotional well-being and reduce stress, factors that may influence recovery from facial palsy. By incorporating mindfulness into the treatment regimen, there is hope that patients might experience improved outcomes alongside traditional physical therapy.

What evidence suggests that mindfulness could be effective for facial palsy?

This trial will compare the effects of mindfulness sessions with standard care for individuals with facial palsy. Studies have shown that mindfulness can reduce symptoms like anxiety and depression. These benefits may also improve mental well-being and self-perception in people with facial palsy. Mindfulness involves paying attention to the present moment, which can help manage stress and emotional challenges. Although little research specifically addresses mindfulness for synkinesis (uncontrolled facial movements), mindfulness has effectively promoted relaxation, which might help manage these movements. Overall, mindfulness shows promise for improving emotional health and could benefit those with facial paralysis.16789

Who Is on the Research Team?

KG

Katherine Gossett, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for individuals who have had non-flaccid facial paralysis for at least 8 months due to Bell's Palsy, Ramsay Hunt syndrome, Lyme disease, or after surgery for an acoustic neuroma. People with a history of cancer, facial surgery, or those who've received botox or physical therapy for their paralysis cannot participate.

Inclusion Criteria

I was diagnosed with facial paralysis not caused by injury over 8 months ago.

Exclusion Criteria

I have had cancer or facial surgery in the past.
I have received treatments like botox or physical therapy for facial paralysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard physical therapy or physical therapy with mindfulness sessions for 8 weeks

8 weeks
8 visits (virtual for mindfulness sessions), 8 visits (in-person for physical therapy)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mindfulness
Trial Overview The study is testing the effects of mindfulness sessions on anxiety, depression, body image issues and synkinesis (involuntary movements) in people with non-flaccid facial paralysis. Participants will either attend mindfulness sessions or not as part of the research.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness SessionsExperimental Treatment1 Intervention
Group II: No Mindfulness SessionsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

Mindfulness for Facial Palsy · Info for ParticipantsThe purpose of this study is to learn more about how mindfulness techniques can help reduce anxiety, depression and body image disturbance as well as ...
a systematic review of diagnostic tools for peripheral facial ...This review identified several validated tools for PFP assessment, with the Sunnybrook and House-Brackmann scales being the most reliable.
A 5-Year Experience at the Massachusetts Eye and Ear InfirmaryFor 160 patients with facial paralysis, statistically significant improvements after facial rehabilitation were shown; the improvements appeared to be long ...
A Two-Stage Nominal Group and Delphi Study | Facial ...This study brings together the global community's expertise as a first step toward establishing best practice for specialist facial therapy.
Facial exercise therapy for facial palsy: systematic review ...The effectiveness of facial exercises therapy for facial palsy has been debated in systematic reviews but its effects are still not totally explained.
Exploring extended reality as a therapy for patients with ...These innovations offer exciting possibilities for enhancing patient care and optimizing outcomes for patients experiencing facial paralysis and muscle deficits ...
Effectiveness of Non-Pharmacological Interventions in ...These findings suggest that both ES and LLT, when applied through various modalities, appear to be safe and effective non-pharmacological ...
Top Treatment for Mindfulness Clinical Trials | PowerEvery trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage. Learn More ...
Mindfulness in Nonflaccid Facial Paralysis - ClinicalTrials.VeevaThe purpose of this study is to learn more about how mindfulness techniques can help reduce anxiety, depression and body image disturbance ...
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