Effect of Preksha Meditation on Cognitive Abilities and Pulmonary Function in Students

• Sponsor: Orlando Regional Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03779269
• Collaborator: Florida International University (Other)
• Enrollment: 142
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 103
• Patients Per Site: 71
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The goal of this project is to assess impact of an 8 week course of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group of college students to assess potential benefits to their pulmonary function, cognitive ability (immediate recall, attention), and happiness.

Condition or Disease	Intervention/Treatment	Phase
Inattention and Memory; Affect	Other: meditation	N/A

Detailed Description

Preksha Meditation Research: The goal of this project is to assess impact of an 8 week course of Preksha Meditation (combination of Green color and buzzing sound meditation), in a group of college students to assess potential benefits to their pulmonary function, cognitive ability (immediate recall, attention), and happiness. The investigators will compare the data received from prior study to analyze their performance before and after. The investigators will also compare this data with control group data, to assess potential improvements as a benchmark. Analyse the EEG data to investigate its impact on brain. Further analyze their blood cells if they show any epigenetic changes. Data analysis team will be blinded for no identifiers are available.

METHOD AND PROCEDURES:

The data analysis will be undertaken by experts and will be blinded. The data currently is only de-identified.

The data which is already collected from the research "Effect of Preksha Meditation (Green color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students with a Control Group" will be analyzed. The data is related to students having practiced minimum 3 guided 25 minute sessions per week in a controlled environment. The control group did not meditate for those weeks when they enrolled in the program.

The intervention the subjects received was as follows:

Experimental group 3 days per week Sessions: 5 minutes: Relaxation and Review of Meditation Practices 10 minutes: Mahapraan Meditation 10 minutes: Green color meditation Begin in stages

• 0 - 2 Weeks: Teach technique and carry out 15 minutes meditation sessions.

• 2 - 9 Weeks: Increment meditation sessions to a length of 25 minutes. 5 minutes: Review of meditation experience and collection of information

Study Design

• Study Type: Interventional
• Actual Enrollment: 142 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: prospective convenience controlled studyprospective convenience controlled study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Preksha Meditation (Green Color and Buzzing Meditation) on Cognitive Abilities and Pulmonary Function in Students With a Control Group
• Actual Study Start Date: May 14, 2017
• Anticipated Primary Completion Date: Mar 14, 2025
• Anticipated Study Completion Date: Dec 14, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: color meditation only color meditation	Other: meditation; meditation effect assessment using assessment tools.
Experimental: Sound meditation Only sound mediation	Other: meditation; meditation effect assessment using assessment tools.
Experimental: Color and sound combined meditation Combined group	Other: meditation; meditation effect assessment using assessment tools.
No Intervention: Control group Only control group

Outcome Measures

Primary Outcome Measures

1. Cognitive skills assessment using Connor's CPT test [8 weeks]

   Affect, short term memory, inattention,

Secondary Outcome Measures

1. Pulmonary function using actual lung capacity test [8 weeks]

   Spirometry

2. Transcriptomics and epigenetics [8 weeks]

   Upregulation and transcriptional profiling using fold change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy individuals

• No prior experience in meditation

Exclusion Criteria:

• Prior experience with meditation.

• health issues.

• Alcohol

• Smoking.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida International University	Miami Beach	Florida	United States	33199
2	Orlando Regional Medical Center	Orlando	Florida	United States	32806

Sponsors and Collaborators

• Orlando Regional Medical Center
• Florida International University

Investigators

• Principal Investigator: Devendra Mehta, M.D., M. SC., Head, Translational Research

Study Documents (Full-Text)

None provided.

More Information

Publications

• Mehta S, Mehta V, Mehta S, Shah D, Motiwala A, Vardhan J, Mehta N, Mehta D. Multimodal behavior program for ADHD incorporating yoga and implemented by high school volunteers: a pilot study. ISRN Pediatr. 2011;2011:780745. doi: 10.5402/2011/780745. Epub 2011 Aug 11.
• Pragya SU, Cordoba G, Chiu R, Mehta N, Johnson P, Mehta DI, Mehta N. Can The Cognitive Parameters Of College Students With Learning Disabilities Benefit From Using Mahapraan, A Breathing Based Preksha Meditation. Journal of College Teaching & Learning 2014; 11, 4 Epub

• Responsible Party: Devendra Mehta, Director Translational Research laboratory, Orlando Regional Medical Center
• ClinicalTrials.gov Identifier: NCT03779269
• Other Study ID Numbers: IRB-13-0045-CR03
• First Posted: Dec 19, 2018
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 25, 2022