AnxietyNCT04721379
Effect of Heartfulness Meditation on Brain Waves and How Calm One Feels During Meditation
A study testing Meditation in people with Anxiety and Stress, run by WellSpan Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults above 18 years of age willing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
WellSpan Dover Sleep Center
Dover, Pennsylvania, 17315
Jayaram Thimmapuram, 717-495-6027, jthimmapuram@wellspan.org
About this study
Official title: Impact of Heartfulness Meditation on EEG (Brain Waves) and Meditation Depth
Objectives:
- 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.
- 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.
- 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
Read the detailed description
Neurological correlates of states of mind during meditation have been studied with Electroencephalogram (EEG) and functional MRIs for many decades. Meditation practices produce distinct EEG brain waveforms, and this may be reflective of the overall subjective experiences. Long term meditators using mindfulness have shown gamma activation on EEG recordings. Practice of Yoganidra and Sahaja meditation have been reported to show increased theta activity. Transcendental Meditation practices have shown alpha waves during meditative periods. While most of the meditative practices may appear similar, there may be subtle differences that might make them better suited for particular conditions. However, most of the studies conducted were small, non-randomized and therefore the outcomes are unclear.
The investigators wish to conduct a randomized controlled prospective study using Heartfulness meditation techniques. Heartfulness meditation practice is a simple heart-based meditation practice that has been shown to improve burnout, emotional wellness and sleep. In a younger subset of patients, it has also shown to increase the telomere length. However, the neurological and physiological correlates of this practice have not been assessed. This study will investigate whether using this novel approach of a heart-based meditation program leads to measurable changes in the EEG and also whether there is any correlation with the waveforms and the depth of meditation. This may provide an explanation from a neurological basis for the improvement of certain wellness parameters such as sleep. In addition, meditation practices have been shown to have positive benefits on cardiovascular system including heart rate variability (HRV). Cardiovascular physiology measured by continuous electrocardiogram (EKG) monitoring is a non-invasive way of measuring HRV. In this study, a correlation of the EEG and HRV with the subjective depth of meditation experience measured through meditation depth questionnaire (MEDEQ) along with baseline anxiety score as measured by generalized anxiety disorder scale (GAD-7) will be assessed.
Primary outcome and Hypotheses:
- The primary outcome will be observing a change in EEG pattern of subjects who follow a Heartfulness guided meditation as compared to unguided self-relaxation and meditation.
- The study team hypothesize that guided Heartfulness meditation will be associated with deeper relaxed brain wave patterns - predominantly theta and delta waves - compared to beta and alpha waves in unguided self-relaxation and meditation. The investigators anticipate that subjects will perceive an increased depth of meditation during a guided relaxation session compared to simply closing the eyes for the duration of the study. Since participants have no prior meditation experience, the investigators hypothesize that the first attempt at meditation is adequate to induce a relaxed state and EEG changes.
- With regards to EKG changes, the study team hypothesize that there will be a reduction in heart rate and increased beat-to-beat variability with guided meditation as compared to unguided self-relaxation for the same duration.
- Being tested
- Meditation
- Keywords
- meditation, Heartfulness, EEG, Heart rate
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Heartfulness Meditation Group | Experimental | 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. Receives: Behavioral: Meditation |
| Control Group with Self Meditation | Active comparator | 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. Receives: Behavioral: Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain wave changes with Heartfulness guided meditation comparing with self-guided meditation
During meditation, EEG will be recorded using brain wave leads.
Measured: 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.
Measured: 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
Measured: After the meditation session, average of 10 minutes
Secondary outcomes (1)
Generalized Anxiety score
Using Generalized Anxiety Disorder -7 score. Scores 5-9 indicate mild anxiety, 10-14 indicate moderate anxiety and 15-21 indicate severe anxiety.
Measured: Before the meditation session, average of 5 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start31 Jul 2021
- Primary completion15 Aug 2022 (estimated)
- Study completion15 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two groups. 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Thimmapuram, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721379
- Sponsor's protocol ID
- 1654972
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Heartfulness Meditation on EEG (Brain Waves) and Meditation Depth
- ClinicalTrials.gov ID
- NCT04721379
- Acronym / sponsor ID
- 1654972
- Keywords
- meditation, Heartfulness, EEG, Heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 31 Jul 2021 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 15 Feb 2023 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- 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.
- 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.
- 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
Detailed description
Neurological correlates of states of mind during meditation have been studied with Electroencephalogram (EEG) and functional MRIs for many decades. Meditation practices produce distinct EEG brain waveforms, and this may be reflective of the overall subjective experiences. Long term meditators using mindfulness have shown gamma activation on EEG recordings. Practice of Yoganidra and Sahaja meditation have been reported to show increased theta activity. Transcendental Meditation practices have shown alpha waves during meditative periods. While most of the meditative practices may appear similar, there may be subtle differences that might make them better suited for particular conditions. However, most of the studies conducted were small, non-randomized and therefore the outcomes are unclear.
The investigators wish to conduct a randomized controlled prospective study using Heartfulness meditation techniques. Heartfulness meditation practice is a simple heart-based meditation practice that has been shown to improve burnout, emotional wellness and sleep. In a younger subset of patients, it has also shown to increase the telomere length. However, the neurological and physiological correlates of this practice have not been assessed. This study will investigate whether using this novel approach of a heart-based meditation program leads to measurable changes in the EEG and also whether there is any correlation with the waveforms and the depth of meditation. This may provide an explanation from a neurological basis for the improvement of certain wellness parameters such as sleep. In addition, meditation practices have been shown to have positive benefits on cardiovascular system including heart rate variability (HRV). Cardiovascular physiology measured by continuous electrocardiogram (EKG) monitoring is a non-invasive way of measuring HRV. In this study, a correlation of the EEG and HRV with the subjective depth of meditation experience measured through meditation depth questionnaire (MEDEQ) along with baseline anxiety score as measured by generalized anxiety disorder scale (GAD-7) will be assessed.
Primary outcome and Hypotheses:
- The primary outcome will be observing a change in EEG pattern of subjects who follow a Heartfulness guided meditation as compared to unguided self-relaxation and meditation.
- The study team hypothesize that guided Heartfulness meditation will be associated with deeper relaxed brain wave patterns - predominantly theta and delta waves - compared to beta and alpha waves in unguided self-relaxation and meditation. The investigators anticipate that subjects will perceive an increased depth of meditation during a guided relaxation session compared to simply closing the eyes for the duration of the study. Since participants have no prior meditation experience, the investigators hypothesize that the first attempt at meditation is adequate to induce a relaxed state and EEG changes.
- With regards to EKG changes, the study team hypothesize that there will be a reduction in heart rate and increased beat-to-beat variability with guided meditation as compared to unguided self-relaxation for the same duration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two groups. 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.
| Arm | Type | Receives |
|---|---|---|
| Heartfulness Meditation Group | Experimental | Behavioral: MeditationParticipants 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 comparator | Behavioral: MeditationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults above 18 years of age willing to participate in the study.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation1. 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. | Behavioural | Control Group with Self Meditation, Heartfulness Meditation Group |
Primary outcome
Brain wave changes with Heartfulness guided meditation comparing with self-guided meditation
Time frame: Through completion of study, average of one hour.
During meditation, EEG will be recorded using brain wave leads.
EKG changes with Heartfulness guided meditation comparing with self-guided meditation
Time frame: Through completion of study, average of one hour.
During meditation, EKG will be recorded using chest leads.
Meditation depth Index questionnaire with Heartfulness guided meditation comparing with self-guided meditation
Time frame: After the meditation session, average of 10 minutes
The questionnaire will be completed after the 10 minute meditation session and again after 30 minute meditation session
1 secondary outcome
Generalized Anxiety score
Time frame: Before the meditation session, average of 5 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Anxiety and Stress, run by WellSpan Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayaram Thimmapuram, MD (717-851-2223, jthimmapuram@wellspan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.