Clinical trial NCT05528978: Impact of Inner Engineering on Relationships
Official title: Impact of Inner Engineering Yoga Program on Interpersonal Relationships
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relationship, Social
Keywords: Yoga
Stress
Wellbeing
Mindfulness
Meditation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This population has enrolled in an Inner Engineering program to learn Shambhavi Mahamudra Kriya.

Brief summary: This study aims to assess the impact of Shambhavi Mahamudra Kriya on human relationships in terms of overall well-being associations with interpersonal and relational outcomes.

Specific aims include:

1. To quantitatively assess the impact of Shambhavi Mahamudra Kriya on measures of relationship quality, interpersonal mindfulness, and overall well-being
2. To qualitatively explore the experience and the general Social and Relational impact of Shambhavi Mahamudra Kriya on participants.

Detailed description: This observational cross-sectional study aims to enroll participants who are already registered for an Inner Engineering program to learn Shambhavi Mahamudra Kriya

The practice participants are learning is a multi-component 21-minute meditation called Shambhavi Mahamudra Kriya. It is offered by the non-profit Isha Foundation. It incorporates a combination of different breathing patterns and meditative components. The intervention training provides precise, step by step and easy to follow instructions on how to perform this practice. Performed in a seated posture, this is a simple, safe and accessible intervention that requires no previous experience of meditation.

Some Inner Engineering programs where participants learn Shambhavi Mahamudra Kriya have a pre-requisite of taking the Inner Engineering Online (IEO) program. The IEO program consists of seven online modules. These modules give the participants an opportunity to intellectually explore the basics of life using methods that are from the distilled essence of yogic sciences. The course imparts wisdom to manage the body, mind, emotions, and the fundamental life energy within.

Importantly, the participants would be able to attend their Inner Engineering program and subsequent meditation and yoga practices would occur regardless of whether or not they decided to participate in the study.

With this study we aim to evaluate the impact of Shambhavi Kriya on relationships using validated scales and qualitative analysis. Enrollment into the study will be ongoing until we are able to get a sufficient sample size. Apart from the surveys and qualitative interviews at select points over a 6-month period, there is no additional study procedures involved in the study, details of which are discussed below.

Eligibility criteria: Inclusion Criteria:

* Participants who have registered to take an Inner Engineering program to learn Shambhavi Mahamudra Kriya.
* Participants must be able to read and understand English.

Exclusion Criteria:

* Not currently residing in United States
* Below the age of 18

Primary outcomes:
measure: Change in Positive and Negative Relationship Quality (PN-RQ) over 6 months
timeFrame: Data collection at baseline, immediately after the intervention, week 6, 6 months
Secondary outcomes:
measure: Change in Perceived Stress Scale (PSS) over 6 months
timeFrame: Data collection at baseline, immediately after the intervention, week 6, 6 months
measure: Change in Interpersonal Mindfulness Scale (IMS) over 6 months
timeFrame: Data collection at baseline, immediately after the intervention, week 6, 6 months
measure: Change in Flourishing Scale over 6 months
timeFrame: Data collection at baseline, immediately after the intervention, week 6, 6 months
measure: Compliance questionnaire
timeFrame: weekly for 6 weeks post-Inner Engeineering program and monthly for 6 months.
measure: Qualitative Interviews
timeFrame: Between week 6-16 weeks
measure: Change in Compassion Scale (CS) over 6 months
timeFrame: Data collection at baseline, immediately after the intervention, week 6, 6 months
measure: Change in Satisfaction Survey
timeFrame: At week 6 and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Centre
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundar Subramaniam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: