Trial Outcomes & Findings for Mindfulness During COVID-19 (NCT NCT04319445)
NCT ID: NCT04319445
Last Updated: 2022-03-02
Results Overview
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?"
COMPLETED
NA
144 participants
Post-Intervention (upon completion of session up to 15 minutes)
2022-03-02
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
144
|
|
Overall Study
COMPLETED
|
144
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness During COVID-19
Baseline characteristics by cohort
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
108 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Helpfulness of the Session
|
89 percentage of participants
|
PRIMARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Platform Effectiveness
|
89 percentage of participants
|
SECONDARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Change in Anxiety Level
|
76 percentage of participants
|
SECONDARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Change in Stress Level
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Value of the Session
|
87 percentage of participants
|
SECONDARY outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Satisfaction With the Session
|
92 percentage of participants
|
SECONDARY outcome
Timeframe: Post-Intervention (upon completion of session up to 15 minutes)Percentage of participants that showed interest in a future session
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Percentage of Participants That Showed Interest in a Future Session
|
131 Participants
|
SECONDARY outcome
Timeframe: Post-Intervention (upon completion of session up to 15 minutes)Percentage of participants that would recommend this session to a family member
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Percentage of Participants That Would Recommend This Session to a Family Member
|
137 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Percentage of Participants by Session Frequency Preference - Daily
|
51 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Percentage of Participants by Session Frequency Preference - Weekly
|
69 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Percentage of Participants by Session Frequency Preference - Monthly
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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?"
Outcome measures
| Measure |
Migraine Patients/Providers/Faculty/Staff/Other
n=144 Participants
Mindfulness session(s): The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
|
|---|---|
|
Decreased Concern Level About the COVID 19 Pandemic
|
79 Participants
|
Adverse Events
Migraine Patients/Providers/Faculty/Staff/Other
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca E Wells, MD, MPH
Wake Forest University Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place