Mindfulness During COVID-19
Study Details
Study Description
Brief Summary
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Migraine Patients/Providers/Faculty/Staff/Other
|
Behavioral: Mindfulness session(s)
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
Outcome Measures
Primary Outcome Measures
- Helpfulness of the Session [Post-Intervention (upon completion of session up to 15 minutes)]
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?"
- Platform Effectiveness [Post-Intervention (upon completion of session up to 15 minutes)]
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?"
Secondary Outcome Measures
- Change in Anxiety Level [Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)]
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?"
- Change in Stress Level [Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)]
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?"
- Value of the Session [Post-Intervention (upon completion of session up to 15 minutes)]
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?"
- Satisfaction With the Session [Post-Intervention (upon completion of session up to 15 minutes)]
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?"
- Percentage of Participants That Showed Interest in a Future Session [Post-Intervention (upon completion of session up to 15 minutes)]
Percentage of participants that showed interest in a future session
- 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 that would recommend this session to a family member
- Percentage of Participants by Session Frequency Preference - Daily [Post-Intervention (upon completion of session up to 15 minutes)]
Percentage of participants that would prefer to participate in daily similar sessions again if offered
- Percentage of Participants by Session Frequency Preference - Weekly [Post-Intervention (upon completion of session up to 15 minutes)]
Percentage of participants that would prefer to participate in weekly similar sessions again if offered
- Percentage of Participants by Session Frequency Preference - Monthly [Post-Intervention (upon completion of session up to 15 minutes)]
Percentage of participants that would prefer to participate in monthly similar sessions again if offered
Other Outcome Measures
- Decreased Concern Level About the COVID 19 Pandemic [Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)]
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?"
Eligibility Criteria
Criteria
Inclusion Criteria:
- Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.
Exclusion Criteria:
- None
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Wake Forest Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Rebecca E Wells, MD, MPH, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00064587
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Period Title: Overall Study | |
STARTED | 144 |
COMPLETED | 144 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Overall Participants | 144 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
48.6
(15.6)
|
Sex: Female, Male (Count of Participants) | |
Female |
117
81.3%
|
Male |
27
18.8%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
4
2.8%
|
Asian |
16
11.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
11
7.6%
|
White |
108
75%
|
More than one race |
0
0%
|
Unknown or Not Reported |
5
3.5%
|
Region of Enrollment (participants) [Number] | |
United States |
144
100%
|
Outcome Measures
Title | Helpfulness of the Session |
---|---|
Description | 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?" |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
89
61.8%
|
Title | Platform Effectiveness |
---|---|
Description | 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?" |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
89
61.8%
|
Title | Change in Anxiety Level |
---|---|
Description | 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?" |
Time Frame | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
76
52.8%
|
Title | Change in Stress Level |
---|---|
Description | 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?" |
Time Frame | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
80
55.6%
|
Title | Value of the Session |
---|---|
Description | 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?" |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
87
60.4%
|
Title | Satisfaction With the Session |
---|---|
Description | 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?" |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Number [percentage of participants] |
92
63.9%
|
Title | Percentage of Participants That Showed Interest in a Future Session |
---|---|
Description | Percentage of participants that showed interest in a future session |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
131
91%
|
Title | Percentage of Participants That Would Recommend This Session to a Family Member |
---|---|
Description | Percentage of participants that would recommend this session to a family member |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
137
95.1%
|
Title | Percentage of Participants by Session Frequency Preference - Daily |
---|---|
Description | Percentage of participants that would prefer to participate in daily similar sessions again if offered |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
51
35.4%
|
Title | Decreased Concern Level About the COVID 19 Pandemic |
---|---|
Description | 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?" |
Time Frame | Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
79
54.9%
|
Title | Percentage of Participants by Session Frequency Preference - Weekly |
---|---|
Description | Percentage of participants that would prefer to participate in weekly similar sessions again if offered |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
69
47.9%
|
Title | Percentage of Participants by Session Frequency Preference - Monthly |
---|---|
Description | Percentage of participants that would prefer to participate in monthly similar sessions again if offered |
Time Frame | Post-Intervention (upon completion of session up to 15 minutes) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other |
---|---|
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). |
Measure Participants | 144 |
Count of Participants [Participants] |
24
16.7%
|
Adverse Events
Time Frame | 15 minutes | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Migraine Patients/Providers/Faculty/Staff/Other | |
Arm/Group Description | Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc). | |
All Cause Mortality |
||
Migraine Patients/Providers/Faculty/Staff/Other | ||
Affected / at Risk (%) | # Events | |
Total | 0/144 (0%) | |
Serious Adverse Events |
||
Migraine Patients/Providers/Faculty/Staff/Other | ||
Affected / at Risk (%) | # Events | |
Total | 0/144 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Migraine Patients/Providers/Faculty/Staff/Other | ||
Affected / at Risk (%) | # Events | |
Total | 0/144 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Rebecca E Wells, MD, MPH |
---|---|
Organization | Wake Forest University Health Sciences |
Phone | 336-716-2357 |
rewells@wakehealth.edu |
- IRB00064587