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The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.The investigators are interested in targeting patients with migraine, providers, faculty and staff. The investigators are hopeful that this will positively impact overall well-being at this stressful time. The investigators are interested in assessing feasibility, accessibility, and overall interest of an online mindfulness intervention in these populations at this time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness session(s) | Behavioral | The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Helpfulness of the Session | Percentage of Participants who Felt the Mindfulness Session was Helpful - After the mindfulness session, participants used a Likert scale rating to respond to the question "How helpful was this session for you?" | Post-Intervention (upon completion of session up to 15 minutes) |
| Platform Effectiveness | Percentage of Participants who Perceived the Electronic Platform to be Effective for Practicing Mindfulness - After the mindfulness session, participants used a Likert scale rating to respond to the question "Did you find this electronic platform effective for practicing mindfulness?" | Post-Intervention (upon completion of session up to 15 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anxiety Level | Percentage of Participants With Reduction in Anxiety After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how anxious do you feel?" | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Decreased Concern Level About the COVID 19 Pandemic | Percent of Participants With Reduction in Concern over COVID-19 After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how concerned are you about the Coronavirus pandemic?" | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca E Wells, MD, MPH | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Migraine Patients/Providers/Faculty/Staff/Other | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Migraine Patients/Providers/Faculty/Staff/Other | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Helpfulness of the Session | Percentage of Participants who Felt the Mindfulness Session was Helpful - After the mindfulness session, participants used a Likert scale rating to respond to the question "How helpful was this session for you?" | Posted | Number | percentage of participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
|
15 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Migraine Patients/Providers/Faculty/Staff/Other | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca E Wells, MD, MPH | Wake Forest University Health Sciences | 336-716-2357 | rewells@wakehealth.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 12, 2020 | Feb 24, 2022 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2020 | Apr 30, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D001008 | Anxiety Disorders |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Change in Stress Level |
Percentage of Participants With Reduction in Stress After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how much stress do you feel?" |
| Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
| Value of the Session | Percentage of Participants who Felt the Mindfulness Session was Valuable - After the mindfulness session, participants used a Likert scale rating to respond to the question "How much was the session of value to you?" | Post-Intervention (upon completion of session up to 15 minutes) |
| Satisfaction With the Session | Percentage of Participants who were Satisfied with the Mindfulness Session - After the mindfulness session, participants used a Likert scale rating to respond to the question "How satisfied are you with this experience?" | Post-Intervention (upon completion of session up to 15 minutes) |
| Percentage of Participants That Showed Interest in a Future Session | Percentage of participants that showed interest in a future session | Post-Intervention (upon completion of session up to 15 minutes) |
| Percentage of Participants That Would Recommend This Session to a Family Member | Percentage of participants that would recommend this session to a family member | Post-Intervention (upon completion of session up to 15 minutes) |
| Percentage of Participants by Session Frequency Preference - Daily | Percentage of participants that would prefer to participate in daily similar sessions again if offered | Post-Intervention (upon completion of session up to 15 minutes) |
| Percentage of Participants by Session Frequency Preference - Weekly | Percentage of participants that would prefer to participate in weekly similar sessions again if offered | Post-Intervention (upon completion of session up to 15 minutes) |
| Percentage of Participants by Session Frequency Preference - Monthly | Percentage of participants that would prefer to participate in monthly similar sessions again if offered | Post-Intervention (upon completion of session up to 15 minutes) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Platform Effectiveness | Percentage of Participants who Perceived the Electronic Platform to be Effective for Practicing Mindfulness - After the mindfulness session, participants used a Likert scale rating to respond to the question "Did you find this electronic platform effective for practicing mindfulness?" | Posted | Number | percentage of participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
|
|
| Secondary | Change in Anxiety Level | Percentage of Participants With Reduction in Anxiety After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how anxious do you feel?" | Posted | Number | percentage of participants | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
|
|
|
| Secondary | Change in Stress Level | Percentage of Participants With Reduction in Stress After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how much stress do you feel?" | Posted | Number | percentage of participants | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
|
|
|
| Secondary | Value of the Session | Percentage of Participants who Felt the Mindfulness Session was Valuable - After the mindfulness session, participants used a Likert scale rating to respond to the question "How much was the session of value to you?" | Posted | Number | percentage of participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
|
|
| Secondary | Satisfaction With the Session | Percentage of Participants who were Satisfied with the Mindfulness Session - After the mindfulness session, participants used a Likert scale rating to respond to the question "How satisfied are you with this experience?" | Posted | Number | percentage of participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
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| Secondary | Percentage of Participants That Showed Interest in a Future Session | Percentage of participants that showed interest in a future session | Posted | Count of Participants | Participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
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| Secondary | Percentage of Participants That Would Recommend This Session to a Family Member | Percentage of participants that would recommend this session to a family member | Posted | Count of Participants | Participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
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| Secondary | Percentage of Participants by Session Frequency Preference - Daily | Percentage of participants that would prefer to participate in daily similar sessions again if offered | Posted | Count of Participants | Participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
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| Other Pre-specified | Decreased Concern Level About the COVID 19 Pandemic | Percent of Participants With Reduction in Concern over COVID-19 After Mindfulness Session - Before and after the mindfulness session, participants responded to the question, "At this moment, how concerned are you about the Coronavirus pandemic?" | Posted | Count of Participants | Participants | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
|
|
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| Secondary | Percentage of Participants by Session Frequency Preference - Weekly | Percentage of participants that would prefer to participate in weekly similar sessions again if offered | Posted | Count of Participants | Participants | Post-Intervention (upon completion of session up to 15 minutes) |
|
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| Secondary | Percentage of Participants by Session Frequency Preference - Monthly | Percentage of participants that would prefer to participate in monthly similar sessions again if offered | Posted | Count of Participants | Participants | Post-Intervention (upon completion of session up to 15 minutes) |
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| 0 |
| 144 |
| 0 |
| 144 |
| 0 |
| 144 |
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| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |