Effects of Mindfulness Meditation on Facial Paralysis Patients

Facial Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03622697
• Other study ID #: IRB00135870
• Status: Withdrawn
• Phase: N/A
• Start date: July 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Paralysis

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Johns Hopkins - Green Spring Station	Lutherville-Timonium	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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