Effects of Mindfulness Meditation on Facial Paralysis Patients

October 12, 2021 updated by: Johns Hopkins University

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale
Time Frame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Time Frame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Time Frame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Reported Quality of Life as assessed by a Visual Analog Scale
Time Frame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Time Frame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
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
Time Frame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
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
Time Frame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa Ishii, MD, MHS, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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