Effects of Mindfulness Meditation on Facial Paralysis Patients

Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Facial Paralysis
• Intervention / Treatment: Behavioral: Mindfulness Meditation Phone Application

Detailed Description

In this study population, facial paralysis was significantly associated with increased loneliness, decreased social function, decreased comfort with socializing, and worse quality of life scores. Furthermore, prior studies have shown that facial paralysis increases the likelihood of depression as measured on validated psychometric instruments. Currently, treating 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. To better provide patient-centered care, physicians should consider the psychosocial impact of facial paralysis to identify patients who may benefit from additional support interventions to complement facial reanimation treatment plans.

This is a prospective repeated measures study examining psychosocial status as measured by validated psychometric instruments. The intervention group will participate in mindfulness meditation using a phone application. Assessment of social functioning and quality of life will be conducted using survey instruments.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
    • Lutherville-Timonium, Maryland, United States, 21093
      • Johns Hopkins - Green Spring Station

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Meditation Arm; Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention.	Behavioral: Mindfulness Meditation Phone Application; 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.
No Intervention: Non-Intervention Arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Reported Quality of Life as assessed by a Visual Analog Scale	Quality of life will be measured using the validated quality of life visual analog scale (single-item questionnaire ranging from 0 to 100 with greater numbers indicating a higher quality of life)	Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Changes in Anxiety assessed by the State-Trait Anxiety Inventory	Anxiety will be measured using the validated State-Trait Anxiety Inventory with 20 items measuring trait anxiety and 20 items measuring state anxiety, each with categorical responses ranging from "never" to "very much so" in response statements regarding how one feels generally (trait) and at the current moment (state)	Change from baseline at 2 weeks, 4 weeks, 6 weeks
Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised	Mindfulness will be measured using the validated Cognitive and Affective Mindfulness Scale-Revised which is a 12-item questionnaire with categorical responses ranging "rarely/not at all" to "almost always" regarding statements about one's experience of mindfulness with minimum score of 12 points to a maximum score of 48 points where a higher score indicates greater mindful qualities	Change from baseline at 2 weeks, 4 weeks, 6 weeks
Changes in Physical Functioning as assessed by Facial Disability Index	Facial disability index (physical functioning portion) - categorical responses ranging from "usually with no difficulty" to "usually did not do because of health" for physical problems associated with facial muscle function over the past month to measure physical functioning; the minimum to maximum score range for social functioning is 0 to 25 with a higher score indicating worse physical function	Change from baseline at 2 weeks, 4 weeks, 6 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Lisa Ishii, MD, MHS, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; social functioning; mindfulness; meditation; facial paralysis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Facial Nerve Diseases; Paralysis; Bell Palsy; Facial Paralysis; Facies
• Other Study ID Numbers: IRB00135870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No