Effects of Mindfulness Meditation on Facial Paralysis Patients
Primary Purpose
Facial Paralysis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation Phone Application
Sponsored by
About this trial
This is an interventional treatment trial for Facial Paralysis focused on measuring mindfulness, meditation, facial paralysis, quality of life, social functioning
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
- Johns Hopkins - Green Spring Station
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness Meditation Arm
Non-Intervention Arm
Arm Description
Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application 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.
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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)
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)
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
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
Full Information
NCT ID
NCT03622697
First Posted
August 3, 2018
Last Updated
October 12, 2021
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03622697
Brief Title
Effects of Mindfulness Meditation on Facial Paralysis Patients
Official Title
Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study expired in IRB.
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis
Keywords
mindfulness, meditation, facial paralysis, quality of life, social functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness Meditation Arm
Arm Type
Experimental
Arm Description
Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention.
Arm Title
Non-Intervention Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation Phone Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale
Description
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
Time Frame
Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Title
Changes in Social Functioning as assessed by Facial Disability Index
Description
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
Time Frame
Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Title
Changes in Social Functioning as assessed by a Social Functioning Visual Analog Scale
Description
Social functioning visual analog scale - single-item questionnaire ranging from 0 to 100 with greater numbers indicating more comfort in socializing with others
Time Frame
Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Secondary Outcome Measure Information:
Title
Changes in Reported Quality of Life as assessed by a Visual Analog Scale
Description
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)
Time Frame
Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Title
Changes in Anxiety assessed by the State-Trait Anxiety Inventory
Description
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)
Time Frame
Change from baseline at 2 weeks, 4 weeks, 6 weeks
Title
Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised
Description
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
Time Frame
Change from baseline at 2 weeks, 4 weeks, 6 weeks
Title
Changes in Physical Functioning as assessed by Facial Disability Index
Description
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
Time Frame
Change from baseline at 2 weeks, 4 weeks, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Ishii, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Johns Hopkins - Green Spring Station
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28131433
Citation
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.
Results Reference
background
PubMed Identifier
24975623
Citation
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.
Results Reference
background
PubMed Identifier
27930763
Citation
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.
Results Reference
background
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Effects of Mindfulness Meditation on Facial Paralysis Patients
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