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Mindfulness During COVID-19

Primary Purpose

Migraine Disorders, Stress, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness session(s)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine Disorders focused on measuring COVID-19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Migraine Patients/Providers/Faculty/Staff/Other

Arm Description

Outcomes

Primary Outcome Measures

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?"
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?"

Secondary Outcome Measures

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?"
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?"
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?"
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?"
Percentage of Participants That Showed Interest in a Future Session
Percentage of participants that showed interest in a future session
Percentage of Participants That Would Recommend This Session to a Family Member
Percentage of participants that would recommend this session to a family member
Percentage of Participants by Session Frequency Preference - Daily
Percentage of participants that would prefer to participate in daily similar sessions again if offered
Percentage of Participants by Session Frequency Preference - Weekly
Percentage of participants that would prefer to participate in weekly similar sessions again if offered
Percentage of Participants by Session Frequency Preference - Monthly
Percentage of participants that would prefer to participate in monthly similar sessions again if offered

Full Information

First Posted
March 20, 2020
Last Updated
February 24, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04319445
Brief Title
Mindfulness During COVID-19
Official Title
Mindfulness During COVID-19 - Remote Mindfulness Sessions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 23, 2020 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Stress, Anxiety
Keywords
COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Migraine Patients/Providers/Faculty/Staff/Other
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness session(s)
Intervention Description
The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
Primary Outcome Measure Information:
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)
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)
Secondary Outcome Measure Information:
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)
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)
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)
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)
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)
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)
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)
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)
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)
Other Pre-specified Outcome Measures:
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca E Wells, MD, MPH
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness During COVID-19

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