Mindfulness During COVID-19

NCT04319445 | Completed Results

• 1 other identifier: IRB00064587
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Disorders; Stress; Anxiety

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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?"

  Post-Intervention (upon completion of session up to 15 minutes)

• 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?"

  Post-Intervention (upon completion of session up to 15 minutes)

Secondary Outcomes (9)

• Change in Anxiety Level

  Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

• Change in Stress Level

  Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

• Value of the Session

  Post-Intervention (upon completion of session up to 15 minutes)

• Satisfaction With the Session

  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)

Other Outcomes (1)

• Decreased Concern Level About the COVID 19 Pandemic

  Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)

Study Arms (1)

Migraine Patients/Providers/Faculty/Staff/Other

EXPERIMENTAL

Behavioral: Mindfulness session(s)

Interventions

Mindfulness session(s) BEHAVIORAL

The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).

Migraine Patients/Providers/Faculty/Staff/Other

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any person interested in participating in the mindfulness session will be eligible to complete the pre/post surveys and participate in the mindfulness session.

You may not qualify if:

• None

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Anxiety Disorders; COVID-19

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Rebecca E Wells, MD, MPH
• Organization: Wake Forest University Health Sciences

rewells@wakehealth.edu

336-716-2357

Study Officials

• Rebecca E Wells, MD, MPH

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 23, 2020
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: March 2, 2022
• Results First Posted: March 2, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)