NCT04721379

Brief Summary

Objectives:

  1. 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. 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. 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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

January 6, 2021

Last Update Submit

October 6, 2021

Conditions

Keywords

meditationHeartfulnessEEGHeart rate

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

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.

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.

Behavioral: Meditation

Interventions

MeditationBEHAVIORAL

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.

Control Group with Self MeditationHeartfulness Meditation Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

WellSpan Dover Sleep Center

Dover, Pennsylvania, 17315, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Meditation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Jayaram Thimmapuram, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
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

Locations