Effects of Mindfulness Meditation on Facial Paralysis Patients

NCT03622697 | Withdrawn

• 1 other identifier: IRB00135870
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Currently, physicians have several options in addressing the anatomic and physiologic sequela of facial paralysis. However, strategies to address the psychologic and coping ability for patients have not been investigated. The goal is to investigate the effect of mindfulness meditation on social functioning in patients with facial paralysis. This study will also explore whether increasing social functioning in patients with facial paralysis will improve overall quality of life. These questions will be answered using a randomized controlled trial.

Conditions

Facial Paralysis

Keywords

mindfulness; meditation; facial paralysis; quality of life; social functioning

Outcome Measures

Primary Outcomes (3)

• Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale

  University of California, Los Angeles 3-point loneliness scale - minimum score 0, maximum score 100 assessing how often one feels socially isolated, higher indicating greater loneliness

  Change from baseline at 2 weeks, 4 weeks, and 6 weeks

• Changes in Social Functioning as assessed by Facial Disability Index

  Facial disability index (social functioning portion) - categorical responses ranging from "never" to "all of the time" for social problems associated with facial muscle function over the past month to measure social functioning; the minimum to maximum score range for social functioning is 5 to 30 with a higher score indicating greater social functioning

  Change from baseline at 2 weeks, 4 weeks, and 6 weeks

• Changes in Social Functioning as assessed by a Social Functioning Visual Analog Scale

  Social functioning visual analog scale - single-item questionnaire ranging from 0 to 100 with greater numbers indicating more comfort in socializing with others

  Change from baseline at 2 weeks, 4 weeks, and 6 weeks

Secondary Outcomes (4)

• Changes in Reported Quality of Life as assessed by a Visual Analog Scale

  Change from baseline at 2 weeks, 4 weeks, and 6 weeks

• Changes in Anxiety assessed by the State-Trait Anxiety Inventory

  Change from baseline at 2 weeks, 4 weeks, 6 weeks

• Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised

  Change from baseline at 2 weeks, 4 weeks, 6 weeks

• Changes in Physical Functioning as assessed by Facial Disability Index

  Change from baseline at 2 weeks, 4 weeks, 6 weeks

Study Arms (2)

Mindfulness Meditation Arm

EXPERIMENTAL

Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention.

Behavioral: Mindfulness Meditation Phone Application

Non-Intervention Arm

NO INTERVENTION

Patients assigned to the non-intervention arm will not be instructed to use a mindfulness meditation phone application and instead will listen to educational materials.

Interventions

Mindfulness Meditation Phone Application BEHAVIORAL

Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for at least 4 weeks with periodic survey assessments using validated psychometric tools.

Mindfulness Meditation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age
• Must have any-cause facial paralysis

You may not qualify if:

• Patients younger than 18 years old
• Non-English speakers
• Patients without smart-phone access
• Patients with autism
• Patients with schizophrenia
• Patients with an affective psychiatric condition

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins - Green Spring Station

Lutherville-Timonium, Maryland, 21093, United States

Location

Related Publications (3)

• Hoge EA, Bui E, Palitz SA, Schwarz NR, Owens ME, Johnston JM, Pollack MH, Simon NM. The effect of mindfulness meditation training on biological acute stress responses in generalized anxiety disorder. Psychiatry Res. 2018 Apr;262:328-332. doi: 10.1016/j.psychres.2017.01.006. Epub 2017 Jan 26.

  PMID: 28131433 BACKGROUND

• Simkin DR, Black NB. Meditation and mindfulness in clinical practice. Child Adolesc Psychiatr Clin N Am. 2014 Jul;23(3):487-534. doi: 10.1016/j.chc.2014.03.002.

  PMID: 24975623 BACKGROUND

• Nellis JC, Ishii M, Byrne PJ, Boahene KDO, Dey JK, Ishii LE. Association Among Facial Paralysis, Depression, and Quality of Life in Facial Plastic Surgery Patients. JAMA Facial Plast Surg. 2017 May 1;19(3):190-196. doi: 10.1001/jamafacial.2016.1462.

  PMID: 27930763 BACKGROUND

MeSH Terms

Conditions

Facial Paralysis; Social Adjustment

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Lisa Ishii, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 9, 2018
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)