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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489148
Other study ID # 5150225
Secondary ID
Status Completed
Phase N/A
First received March 4, 2018
Last updated April 3, 2018
Start date August 24, 2015
Est. completion date February 4, 2016

Study information

Verified date April 2018
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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®.


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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date February 4, 2016
Est. primary completion date February 4, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tamarkoz®
Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization.
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.

Locations

Country Name City State
United States University of California, Berkeley Berkeley California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Perceived stress scale 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 Salivary Immunoglobulin A (SIgA) in Saliva 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
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