Mindfulness During COVID-19

February 24, 2022 updated by: Wake Forest University Health Sciences

Mindfulness During COVID-19 - Remote Mindfulness Sessions

The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helpfulness of the Session
Time Frame: 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?"
Post-Intervention (upon completion of session up to 15 minutes)
Platform Effectiveness
Time Frame: 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?"
Post-Intervention (upon completion of session up to 15 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Level
Time Frame: 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?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Change in Stress Level
Time Frame: 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?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)
Value of the Session
Time Frame: 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?"
Post-Intervention (upon completion of session up to 15 minutes)
Satisfaction With the Session
Time Frame: 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?"
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Showed Interest in a Future Session
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
Percentage of participants that showed interest in a future session
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants That Would Recommend This Session to a Family Member
Time Frame: Post-Intervention (upon completion of session up to 15 minutes)
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 by Session Frequency Preference - Daily
Time Frame: 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
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Weekly
Time Frame: 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
Post-Intervention (upon completion of session up to 15 minutes)
Percentage of Participants by Session Frequency Preference - Monthly
Time Frame: 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
Post-Intervention (upon completion of session up to 15 minutes)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decreased Concern Level About the COVID 19 Pandemic
Time Frame: 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?"
Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 23, 2020

Primary Completion (ACTUAL)

July 28, 2020

Study Completion (ACTUAL)

July 28, 2020

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00064587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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