Clinical trial NCT03622697: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Facial Paralysis
Keywords: mindfulness
meditation
facial paralysis
quality of life
social functioning
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Social Functioning as assessed by University of California, Los Angeles 3-point loneliness scale
timeFrame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
measure: Changes in Social Functioning as assessed by Facial Disability Index
timeFrame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
measure: Changes in Social Functioning as assessed by a Social Functioning Visual Analog Scale
timeFrame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Secondary outcomes:
measure: Changes in Reported Quality of Life as assessed by a Visual Analog Scale
timeFrame: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
measure: Changes in Anxiety assessed by the State-Trait Anxiety Inventory
timeFrame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
measure: Changes in Mindfulness as measured using the Cognitive and Affective Mindfulness Scale-Revised
timeFrame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
measure: Changes in Physical Functioning as assessed by Facial Disability Index
timeFrame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Lutherville-Timonium
country: United States
facility: Johns Hopkins - Green Spring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa Ishii, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.