Mindfulness During COVID-19

Not Applicable

Completed

• Conditions: Migraine Disorders; Stress; Anxiety
• Interventions: Behavioral: Mindfulness session(s)

• Registration Number: NCT04319445
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-20
• Study Start: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2021-03
• Results First Submitted: 2021-12-22
• Results First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Results First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Migraine Patients/Providers/Faculty/Staff/Other	Mindfulness session(s)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 - 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
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
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?"
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

Trial Locations

Locations (1)

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States