Implications of Tamarkoz® on Stress, Emotion, Spirituality and Heart Rate

April 3, 2018 updated by: Loma Linda University

Implications of Tamarkoz® on Reducing Stress and Heart Rate, and Increasing Positive Emotions, Spirituality

Depression, anxiety, hopelessness, poor sleep quality, somatic pain, high risk of substance abuse, and suicide ideation are positively correlated with perceived stress. Spirituality and positive emotions have profound, positive impacts on health and reduce perceived stress. The current study is an exploration of Tamarkoz®, a Sufi practice that is a method to concentrate, as a pathway by which spirituality and positive emotions effect perceived stress. Tamarkoz® incorporates physical, emotional, and spiritual aspects of an individual. In its current form, it includes Movazaneh® which is movement balancing developed by the Sufi Master, Professor Nader Angha. Movazaneh® movements direct concentration of the mind to a state of collectiveness and activates electromagnetic centers in the body, which are said to develop spirituality in an individual. A national survey of college students indicated that over 80% have interest in spiritual development.

Participants were recruited from the University of California, Berkeley for an 18-week quasi-experimental study with pretest-posttest and follow-up in three groups. Assessments were conducted with blood pressure, heart rate, the 10-item perceived stress scale, the 38-item dispositional positive emotions scale, and the 16-item daily spiritual experiences scale in a Tamarkoz® group, a wait-list control, and a third group utilizing the campus health center's stress management resources. Blood pressure and heart rate measurements were taken by the researcher using a validated home monitoring device. Additionally, all participants provided 3 diurnal saliva samples to determine changes in salivary immunoglobulin A and salivary cortisol. All data were collection was through non-evasive procedures and were assessed at baseline, end of the school semester (12 weeks) and 18 weeks.

Participants, diverse university students, had no prior exposure to Tamarkoz®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is quasi-experimental, waitlist control group design with pretest-posttest. It consisted of three groups: (a) the intervention group who learned Tamarkoz® Sufi meditation practices, (b) a second group of students who utilized self-care stress management resources at the Tang University Health Services Center, and (c) a third group who was the waitlist control group who did not receive Tamarkoz® and did not use the stress management resources at the Tang Center for the duration of the study.

The design is represented in the following diagram. NR O(a) XT O(b) O(d) NR O(d) XS O(e) O(g) NR O(g) O(h) O(i)

XT represents twelve weeks of Tamarkoz® training and XS represents twelve weeks of Tang Center stress management techniques. Each O represents one of three measurements in each group: (a) at baseline, (b) 12 weeks later, immediately after the intervention ends, and (c) six weeks post-intervention. The intervention group met twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met to learn Tamarkoz® techniques. The self-care stress management group used the campus resources for stress management as needed for themselves.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720
        • University of California, Berkeley

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • University of California, Berkeley students between the ages of 18-30 years

Exclusion Criteria:

  • work third shifts
  • diabetes
  • post-traumatic stress disorder
  • liver disease
  • autoimmune diseases
  • severe depression that resists treatment or impacts ability to function
  • schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tamarkoz®
A Sufi method to focus, called Tamarkoz®. Participants had met in class twice a week for two and a half hours total for three months. One day of the week, they met for theoretical teachings of Sufism, and for the second day in the week they met with a Tamarkoz® instructor to learn meditation techniques.
Behavioral: Tamarkoz®
Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization.
Active Comparator: Stress Management Resources
The self-care stress management group used the campus resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, and online reading materials for stress management as needed for themselves.
Behavioral: Stress management resources
Use of the campus health center's stress management resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, pet-an-animal a week, and online reading material about self-care for stress management.
No Intervention: Waitlist
The waitlist control group did not receive Tamarkoz® and did not use the stress management resources on campus for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived stress scale
Time Frame: Change between baseline and 18 weeks
The scale measures the degree to which one perceives situations in one's life as stressful on a Likert Scale of 0 to 4 with 0 indicating never, and 4 indicating very often. Higher scores indicate higher levels of perceived stress.
Change between baseline and 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary Immunoglobulin A (SIgA) in Saliva
Time Frame: Change between baseline and 18 weeks
Analysis of saliva drool analysis of salivary immunoglobbulin A immune cell. Lab will analyze the saliva. Normal levels of SIgA have not been determine.
Change between baseline and 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nasim Bahadorani, DrPH, Loma Linda University
  • Study Chair: Jerry W Lee, PhD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5150225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

Beginning 6 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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