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Mindfulness in Nonflaccid Facial Paralysis

NCT ID: NCT07127016

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Facial Paralysis

Keywords

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non-flaccid facial paralysis synkinesis mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mindfulness Sessions

8 sessions of mindfulness prior to completing their physical therapy session

Group Type EXPERIMENTAL

Mindfulness Sessions

Intervention Type 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.

No Mindfulness Sessions

Standard of care no mindfulness sessions

Group Type ACTIVE_COMPARATOR

No Mindfulness Sessions

Intervention Type BEHAVIORAL

Standard of care physical therapy without mindfulness sessions.

Interventions

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Mindfulness Sessions

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.

Intervention Type BEHAVIORAL

No Mindfulness Sessions

Standard of care physical therapy without mindfulness sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Gossett, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

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Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Joann Bluj, MD

Role: CONTACT

Phone: 570-952-4527

Email: [email protected]

Facility Contacts

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Joann Bluj, MD

Role: primary

Other Identifiers

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IRB00126997

Identifier Type: -

Identifier Source: org_study_id