Effect of Heartfulness Meditation on Brain Waves and How Calm One Feels During Meditation
Impact of Heartfulness Meditation on EEG (Brain Waves) and Meditation Depth
1 other identifier
interventional
80
1 country
1
Brief Summary
Objectives:
- 1.To assess the EEG patterns and EKG recordings of participants with no meditation experience with simply closing the eyes for 10 minutes followed by relaxing for 30 minutes.
- 2.To assess the EEG patterns and EKG recordings of participants with no meditation experience by simply closing the eyes for 10 minutes and then with guided Heartfulness relaxation and meditation for 30 minutes.
- 3.To assess the baseline anxiety score through GAD-7 questionnaire, subjective experience of all the participants through MEDEQ questionnaire that measures the depth of the meditation experience after the session and correlate with the EEG patterns of the brain and heart rate changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable anxiety
Started Jul 2021
Typical duration for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
July 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedOctober 11, 2021
October 1, 2021
1 year
January 6, 2021
October 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Brain wave changes with Heartfulness guided meditation comparing with self-guided meditation
During meditation, EEG will be recorded using brain wave leads.
Through completion of study, average of one hour.
EKG changes with Heartfulness guided meditation comparing with self-guided meditation
During meditation, EKG will be recorded using chest leads.
Through completion of study, average of one hour.
Meditation depth Index questionnaire with Heartfulness guided meditation comparing with self-guided meditation
The questionnaire will be completed after the 10 minute meditation session and again after 30 minute meditation session
After the meditation session, average of 10 minutes
Secondary Outcomes (1)
Generalized Anxiety score
Before the meditation session, average of 5 minutes.
Study Arms (2)
Heartfulness Meditation Group
EXPERIMENTALParticipants will be guided through relaxation and meditation session with a Heartfulness trainer with EEG and EKG recording. After finishing the session, they fill out meditation depth questionnaire.
Control Group with Self Meditation
ACTIVE COMPARATORParticipants will be self-guided through relaxation and meditation session without a trainer with EEG and EKG recording. After finishing the session, they fill out meditation depth questionnaire.
Interventions
1. Group 1 participants with unguided session simply close their eyes for 10 minutes while EEG and EKG recordings are performed. Following 10 minutes, after briefly opening their eyes, they will be asked to relax with eyes closed for 30 minutes. After finishing the session, they fill out meditation depth questionnaire. 2. Group 2 participants with guided sessions close their eyes for 10 minutes while EEG and EKG recordings are performed. Following 10 minutes, after briefly opening their eyes, they will be guided through relaxation and meditation session for 30 minutes with a Heartfulness trainer with continued recording. After finishing the session, they also fill out meditation depth questionnaire.
Eligibility Criteria
You may qualify if:
- Adults above 18 years of age willing to participate in the study.
You may not qualify if:
- Participants unwilling to participate in the study and those with prior meditation experience.
- Participants who are unable to sit for 30 minutes due to either physical or mental conditions will be excluded.
- Participants with bipolar disorder, substance abuse (drugs or alcohol abuse in last 6 months), alcohol withdrawal, BMI \< 18, suicidal ideation, active psychotherapy, major depression, anxiety disorder, obstructive sleep apnea, eating disorder, history of brain surgery or known brain tumors, known seizures or on treatment for seizures, borderline personality disorder, post-traumatic stress disorder, or psychotic disorder.
- Participants with known heart rhythm problems such as atrial fibrillation is advised not to participate.
- Participants on benzodiazepines or psychiatry medications, stimulants or sleeping pills that may potentially interfere with EEG patterns will be excluded.
- Participants on cardiovascular medications that affect the heart rate will be excluded.
- Participants who are unable to have the leads on their scalp or skin will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- WellSpan Healthlead
Study Sites (1)
WellSpan Dover Sleep Center
Dover, Pennsylvania, 17315, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 6, 2021
First Posted
January 22, 2021
Study Start
July 31, 2021
Primary Completion
August 15, 2022
Study Completion
February 15, 2023
Last Updated
October 11, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share