Recruiting

Heartfulness Meditation

Sponsor:

WellSpan Health

Code:

NCT04721379

Conditions

Anxiety

Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Meditation

Study Details

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.

EEG and EKG data from the groups will be analyzed by the sleep specialist. EKG device data for HRV and the EEG data will be correlated with the subjective depth of meditation experience in both the groups

Conditions

Anxiety

Stress

Study ID

NCT04721379

Start date

Jul 31, 2021

Status verified date

Oct, 2021

Completion date

Feb 15, 2023

Anticipated

Primary completion date

Aug 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

• Adults above 18 years of age willing to participate in the study.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Heartfulness Meditation Group

Participants 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.

active comparator: Control Group with Self Meditation

Participants 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

Meditation

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.

Primary outcome measure

  • Brain wave changes with Heartfulness guided meditation comparing with self-guided meditation [ Time Frame: Through completion of study, average of one hour. ]
  • EKG changes with Heartfulness guided meditation comparing with self-guided meditation [ Time Frame: Through completion of study, average of one hour. ]
  • Meditation depth Index questionnaire with Heartfulness guided meditation comparing with self-guided meditation [ Time Frame: After the meditation session, average of 10 minutes ]

Central Contacts and Locations

Central contacts

Jayaram Thimmapuram, MD

717-851-2223jthimmapuram@wellspan.org

Locations

WellSpan Dover Sleep Center

Recruiting

Dover, Pennsylvania, United States, 17315

Contacts

Jayaram Thimmapuram

717-495-6027jthimmapuram@wellspan.org

More Information

Sponsor

WellSpan Health

Last update posted

Oct 11, 2021

Last verified

Oct, 2021

Keywords

  • meditation
  • Heartfulness
  • EEG
  • Heart rate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellSpan Health on 2021-10-11.