Facial ParalysisNCT03622697
Effects of Mindfulness Meditation on Facial Paralysis Patients
A study testing Mindfulness Meditation Phone Application in people with Facial Paralysis, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- Mindfulness Meditation Phone Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Must have any-cause facial paralysis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Johns Hopkins - Green Spring Station
Lutherville-Timonium, Maryland, 21093
About this study
Official title: 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.
Read the 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.
- Conditions
- Facial Paralysis
- Being tested
- Mindfulness Meditation Phone Application
- Keywords
- mindfulness, meditation, facial paralysis, quality of life, social functioning
- Medical subject headings
- Facial Paralysis, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation Phone ApplicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation Arm | Experimental | Mindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention. Receives: Behavioral: Mindfulness Meditation Phone Application |
| Non-Intervention Arm | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Measured: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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
Measured: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
Secondary outcomes (4)
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)
Measured: Change from baseline at 2 weeks, 4 weeks, and 6 weeks
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)
Measured: Change from baseline at 2 weeks, 4 weeks, 6 weeks
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
Measured: Change from baseline at 2 weeks, 4 weeks, 6 weeks
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
Measured: Change from baseline at 2 weeks, 4 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study startJul 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Study expired in IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Ishii, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622697
- Sponsor's protocol ID
- IRB00135870
- Status last verified
- Jun 2021
- First submitted
- 3 Aug 2018
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28131433Simkin 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.
PubMed 24975623Nellis 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.
PubMed 27930763
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Meditation to Improve Social Functioning and Quality of Life in Patients With Facial Paralysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03622697
- Acronym / sponsor ID
- IRB00135870
- Conditions
- Facial Paralysis
- Keywords
- mindfulness, meditation, facial paralysis, quality of life, social functioning
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study expired in IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation Arm | Experimental | Behavioral: Mindfulness Meditation Phone ApplicationMindfulness meditation intervention: patients will be asked to complete a guided mindfulness meditation phone application intervention. |
| Non-Intervention Arm | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients older than 18 years of age
- Must have any-cause facial paralysis
Key exclusion criteria (6 listed)
- Patients younger than 18 years old
- Non-English speakers
- Patients without smart-phone access
- Patients with autism
- Patients with schizophrenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation Phone ApplicationMindfulness 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. | Behavioural | Mindfulness Meditation Arm |
Primary outcome
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
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
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
4 secondary outcomes
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
Changes in Anxiety assessed by the State-Trait Anxiety Inventory
Time frame: 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
Changes in Physical Functioning as assessed by Facial Disability Index
Time frame: Change from baseline at 2 weeks, 4 weeks, 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 28131433Hoge 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.
- Background: PubMed 24975623Simkin 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.
- Background: PubMed 27930763Nellis 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.
- Individual participant dataSharing planned: No
Related trials for Facial Paralysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Ishii, MD, MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation Phone Application in people with Facial Paralysis, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622697, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.