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Relationship, SocialNCT05528978

Impact of Inner Engineering on Relationships

An observational study of Relationship, Social, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 yearsHealthy volunteers can take part
Conditions the study is for
Relationship, Social
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
290 participants
Where
1 siteUnited States
Study dates
13 Nov 2022to 31 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Centre

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Impact of Inner Engineering Yoga Program on Interpersonal Relationships

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.
Read the 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.

Being tested
Shambhavi Kriya
Keywords
Yoga, Stress, Wellbeing, Mindfulness, Meditation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shambhavi KriyaBehavioural

    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.

Study groups in NCT05528978
Study groupRoleWhat they receive
Inner Engineering InterventionThe 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.
Receives: Behavioral: Shambhavi Kriya

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Change in Perceived Stress Scale (PSS) over 6 months

    PSS is a 10-question validated instrument that assesses stress. Participants are asked to rate on a scale of 0 (never) to 4 (very often) how often they agree with various statements. Items from each of the 10 questions are then summed to create a total perceived stress score. This scale will be employed as an online scale which will be utilized by participants to self-report on perceived stress for the purpose of this study.

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

  2. Change in Interpersonal Mindfulness Scale (IMS) over 6 months

    IMS is a 27-item validated instrument that assesses mindfulness in the context of interpersonal interactions grouped into four subscales: presence, awareness of self and others, nonjudgmental acceptance, and nonreactivity. Each statement is rated on a 5-point Likert scale (1= almost never to 5= almost always).

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

  3. Change in Flourishing Scale over 6 months

    The Flourishing Scale is 12-item validated instrument that assess overall well-being in 5 domains: happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, and close social relationships. The "Flourish" measure is the sum of the scores from each of the five domains. The "Secure Flourish" measure includes the financial and material stability domain. Questions are assessed on a scale of 0-10 (0= Not satisfied at all, 10= Completely satisfied).

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

  4. Compliance questionnaire

    The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced, its frequency and duration.

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

  5. Qualitative Interviews

    The semi-structured individual interviews will allow us to gain rich, descriptive information about the participant's experience with the Shambhavi Kriya practice, and the general impact of the practice on the participants. The semi-structured interviews will ensure a systematic and flexible approach to data collection. The interviews will cover the following main topics:

    1. Participants' experience with Shambhavi Kriya practice and
    2. Perceptions of the participants of themselves before and after completing 6 weeks of the practice.

    Measured: Between week 6-16 weeks

  6. Change in Compassion Scale (CS) over 6 months

    The Compassion Scale is a 16-item validated instrument that assess an individual's level of compassion to others in four subscales: Indifference, kindness, mindfulness, and common humanity, Each statement is rated on a 5-point Likert scale (1=almost never, 5= almost always).

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

  7. Change in Satisfaction Survey

    This survey will collect the participants' feedback on the study and Shambhavi Mahamudra Kriya.

    Measured: At week 6 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2022
  2. Study start13 Nov 2022
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05528978
Sponsor's protocol ID
2022P000587
Status last verified
Jun 2024
First submitted
29 Aug 2022
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39764085

Questions about this trial

What is this clinical trial studying?

An observational study of Relationship, Social, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Positive and Negative Relationship Quality (PN-RQ) over 6 months (time frame: Data collection at baseline, immediately after the intervention, week 6, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05528978, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.

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