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Mindfulness in Nonflaccid Facial Paralysis

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Not yet enrolling

Conditions

Facial Paralysis

Treatments

Behavioral: No Mindfulness Sessions
Behavioral: Mindfulness Sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT07127016
IRB00126997

Details and patient eligibility

About

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.

Full description

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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- 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

Exclusion criteria

  • Received treatments such as botox or physical therapy for facial paralysis
  • History of malignancy or facial surgery

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Mindfulness Sessions
Experimental group
Description:
8 sessions of mindfulness prior to completing their physical therapy session
Treatment:
Behavioral: Mindfulness Sessions
No Mindfulness Sessions
Active Comparator group
Description:
Standard of care no mindfulness sessions
Treatment:
Behavioral: No Mindfulness Sessions

Trial contacts and locations

1

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Central trial contact

Joann Bluj, MD

Data sourced from clinicaltrials.gov

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