Inner Engineering Yoga Program on Short and Long Term Health Effects (ISHA-Impact): A Longitudinal Study

NCT04189146 | Completed

• 1 other identifier: 2019P000205
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

This study will include any participant who registered, and plans to attend the Inner Engineering In-Person Completion Course. In 2019, this course was offered in: Los Angeles in March, Philadelphia in April and Toronto \& Dallas in November. This study has been involved in every IECO Course since 2019 and is still active today. Beginning in August 2021, investigators will recruit for the August Inner Engineering In-Person Completion Course. Investigators anticipate that this study can include up to 5,000 study participants. Participants would attend this course and complete the pre-modules regardless of whether or not they participate in this study.

Conditions

Mediation; Mood; Stress; Habits; Nicotine; Alcohol Consumption; Pain Intensity; Sleep; Mindfulness; Emotions; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• Changes in Perceived Stress Levels

  The study aims to evaluate changes in perceived levels of stress in survey participants and the effect Inner Engineering has over them in long term. The investigators use a validated scale for this purpose named, Perceived Stress Scale (PSS). The scale measures the degree to which situations in participant's life are appraised as stressful. This is defined to be the key secondary outcome for the study. Higher scores are suggestive of more stress. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.

  The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

• Mood Changes

  The study aims to evaluate changes in mood profiles affected by the Inner Engineering Online (IEO) over time. For evaluation of mood profiles the investigators use a validated scale named, Profile of Mood States (POMS). The scale measures different dimensions of mood swings over a period of time and calculates Total Mood Disturbances by performing a sub-scale analysis. The subscales defined include Tension, Depression, Anger, Fatigue, Confusion \& Vigor. Higher scores are suggestive of poorer outcome. Logistic regression analysis is performed on the outcome measures collected over the specified time-frame.

  The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

Other Outcomes (9)

• Habits of daily living

  The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

• Nictoine Consumption

  The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

• Alcohol Consumption

  The investigators collect these scores at the 6 pre-specified time points; i.e., at the time of consent; after completing the IEO modules but before conference; post conference completion; at 6 weeks; at 6 months and at 12 months.

Study Arms (1)

Inner Engineering Intervention

OTHER

The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya.

Behavioral: Inner Engineering Intervention

Interventions

Inner Engineering Intervention BEHAVIORAL

The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya. Shambhavi Kriya is a powerful and purifying energy technique incorporating the breath. This practice is said to align the participants system such that their body, mind and emotions function in harmony.

Inner Engineering Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who have registered to take the Inner Engineer Online Course.
• Participants who have registered to take the Inner Engineer Completion Course.
• Participants must be able to read and understand English.

You may not qualify if:

• Participants who report living outside the United States at the time of enrollment.
• Participants \< 18 years of age.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02215, United States

Location

Related Publications (10)

• Hyman SA, Shotwell MS, Michaels DR, Han X, Card EB, Morse JL, Weinger MB. A Survey Evaluating Burnout, Health Status, Depression, Reported Alcohol and Substance Use, and Social Support of Anesthesiologists. Anesth Analg. 2017 Dec;125(6):2009-2018. doi: 10.1213/ANE.0000000000002298.

  PMID: 28991114 BACKGROUND

• Kato T. Development of the Sleep Quality Questionnaire in healthy adults. J Health Psychol. 2014 Aug;19(8):977-86. doi: 10.1177/1359105313482168. Epub 2013 May 29.

  PMID: 23720542 BACKGROUND

• Shioata, M.N., D. Keltner, and O.P. John, Positive Emotion Dispositions Differntially Associatd with Big Five Personality and Attachement Style. The Journal of Positive Psychology, 2006. 1(2): p. 61-71.

  BACKGROUND

• Ryan RM, Frederick C. On energy, personality, and health: subjective vitality as a dynamic reflection of well-being. J Pers. 1997 Sep;65(3):529-65. doi: 10.1111/j.1467-6494.1997.tb00326.x.

  PMID: 9327588 BACKGROUND

• Ryan RM, Deci EL. On happiness and human potentials: a review of research on hedonic and eudaimonic well-being. Annu Rev Psychol. 2001;52:141-66. doi: 10.1146/annurev.psych.52.1.141.

  PMID: 11148302 BACKGROUND

• Peterson CT, Bauer SM, Chopra D, Mills PJ, Maturi RK. Effects of Shambhavi Mahamudra Kriya, a Multicomponent Breath-Based Yogic Practice ( Pranayama), on Perceived Stress and General Well-Being. J Evid Based Complementary Altern Med. 2017 Oct;22(4):788-797. doi: 10.1177/2156587217730934. Epub 2017 Sep 22.

  PMID: 29228793 BACKGROUND

• Muralikrishnan K, Balakrishnan B, Balasubramanian K, Visnegarawla F. Measurement of the effect of Isha Yoga on cardiac autonomic nervous system using short-term heart rate variability. J Ayurveda Integr Med. 2012 Apr;3(2):91-6. doi: 10.4103/0975-9476.96528.

  PMID: 22707866 BACKGROUND

• Selvaraj, N., et al., Heart Rate Dynamics during Shambhavi Mahamudra - A Practice of Isha Yoga. Journal of Complementary and Inegrative Medicine, 2008. 5(1): p. 1-22.

  BACKGROUND

• Swaminathan A, DeSchryver B, Rayapuraju A, Barbaro J, Orui H, Subramaniam B, Reed PU. From strain to strength: a yearlong study on the transformative influence of inner engineering online program on mental well-being. Front Psychol. 2025 Feb 4;16:1436910. doi: 10.3389/fpsyg.2025.1436910. eCollection 2025.

  PMID: 39968198 DERIVED

• Upadhyay P, Joshi A, Mishra I, Kelly L, Novack L, Hariri S, Kveraga K, Subramaniam B. Short Term Effects of Inner Engineering Completion Online Program on Stress and Well-Being Measures. Front Psychol. 2022 Apr 27;13:814224. doi: 10.3389/fpsyg.2022.814224. eCollection 2022.

  PMID: 35572309 DERIVED

Related Links

• ISHA Foundation Website

MeSH Terms

Conditions

Negotiating; Habits; Alcohol Drinking; Pain; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Communication; Behavior; Drinking Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anesthesia Research Excellence

Model Details: This study only involves administration of electronic surveys at six different time points. These time points include: at the time of consent; after completing the Inner Engineering Online modules but before the in-person course begins; after the completion of the in-person (IECO) course; at 6 weeks; at 6 months and at 12 months. These surveys can take up to 15 minutes to complete. Electronic reminders will be sent to participants who have not completed these surveys within a week. Additionally, participants must complete a two-minute compliance survey at the end of each week for 6 weeks after IECO completion. After these 6 weeks, this same two-minute compliance survey will be sent monthly until the end of the year. This survey is an important component of our data analysis, because it collects information on the frequency and duration of their routine practice.

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: December 6, 2019
• Study Start: March 12, 2019
• Primary Completion: December 17, 2023
• Study Completion: December 31, 2023
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)