Anxiety, Migraine Disorders, Stress
Conditions
Keywords
COVID-19
Brief summary
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.
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.
Interventions
BEHAVIORALMindfulness session(s)
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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? |
| 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? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
| 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? |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 144 |
| Total | 144 |
Baseline characteristics
| Characteristic | Migraine Patients/Providers/Faculty/Staff/Other |
|---|---|
| Age, Continuous | 48.6 years STANDARD_DEVIATION 15.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 16 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 108 Participants |
| Region of Enrollment United States | 144 participants |
| Sex: Female, Male Female | 117 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 144 |
| other Total, other adverse events | 0 / 144 |
| serious Total, serious adverse events | 0 / 144 |
Outcome results
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?
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Helpfulness of the Session | 89 percentage of participants |
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?
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Platform Effectiveness | 89 percentage of participants |
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?
Time frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Change in Anxiety Level | 76 percentage of participants |
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?
Time frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Change in Stress Level | 80 percentage of participants |
Secondary
Percentage of Participants by Session Frequency Preference - Daily
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Percentage of Participants by Session Frequency Preference - Daily | 51 Participants |
Secondary
Percentage of Participants by Session Frequency Preference - Monthly
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Percentage of Participants by Session Frequency Preference - Monthly | 24 Participants |
Secondary
Percentage of Participants by Session Frequency Preference - Weekly
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Percentage of Participants by Session Frequency Preference - Weekly | 69 Participants |
Secondary
Percentage of Participants That Showed Interest in a Future Session
Percentage of participants that showed interest in a future session
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Percentage of Participants That Showed Interest in a Future Session | 131 Participants |
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
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Percentage of Participants That Would Recommend This Session to a Family Member | 137 Participants |
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?
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Satisfaction With the Session | 92 percentage of participants |
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?
Time frame: Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Value of the Session | 87 percentage of participants |
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?
Time frame: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Migraine Patients/Providers/Faculty/Staff/Other | Decreased Concern Level About the COVID 19 Pandemic | 79 Participants |