NCT05528978

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 13, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

1.4 years

First QC Date

August 29, 2022

Last Update Submit

June 4, 2024

Conditions

Keywords

YogaStressWellbeingMindfulnessMeditation

Outcome Measures

Primary Outcomes (1)

  • Change in Positive and Negative Relationship Quality (PN-RQ) over 6 months

    PN-RQ Scale is a 16-item validated instrument that assesses relationship quality. On a 7-point Likert Scale (1= not at all, 7= completely) participants rate eight different positive and negative qualities they attribute to their relationship. The average item score in each category is compared, with the higher score indicating the dominating relationship quality.

    Data collection at baseline, immediately after the intervention, week 6, 6 months

Secondary Outcomes (7)

  • Change in Perceived Stress Scale (PSS) over 6 months

    Data collection at baseline, immediately after the intervention, week 6, 6 months

  • Change in Interpersonal Mindfulness Scale (IMS) over 6 months

    Data collection at baseline, immediately after the intervention, week 6, 6 months

  • Change in Flourishing Scale over 6 months

    Data collection at baseline, immediately after the intervention, week 6, 6 months

  • Compliance questionnaire

    weekly for 6 weeks post-Inner Engeineering program and monthly for 6 months.

  • Qualitative Interviews

    Between week 6-16 weeks

  • +2 more secondary outcomes

Study Arms (1)

Inner Engineering Intervention

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: Shambhavi Kriya

Interventions

Shambhavi KriyaBEHAVIORAL

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

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This population has enrolled in an Inner Engineering program to learn Shambhavi Mahamudra Kriya.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Centre

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Jafari N, Manvelian A, Mohamed E, Rayapuraju A, Orui H, Alkuhaimi S, Reed PU, Subramaniam B. Inner engineering is associated with perceived improvements in relationship quality, interpersonal connections, and interpersonal compassion. Front Psychol. 2024 Dec 23;15:1454293. doi: 10.3389/fpsyg.2024.1454293. eCollection 2024.

Study Officials

  • Balachundar Subramaniam, MD, MPH

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

August 29, 2022

First Posted

September 6, 2022

Study Start

November 13, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations