Viewing Study NCT03622697



Ignite Creation Date: 2024-05-06 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 12:51 PM
Study NCT ID: NCT03622697
Status: WITHDRAWN
Last Update Posted: 2021-10-19
First Post: 2018-08-03

Brief Title: Effects of Mindfulness Meditation on Facial Paralysis Patients
Sponsor: Johns Hopkins University
Organization: Johns Hopkins University

Study Overview

Official Title: Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis A Randomized Controlled Trial
Status: WITHDRAWN
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Study expired in IRB
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None