CClinicalTrials.gg
CompletedNCT03489148Updated Apr 5, 2018

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

An interventional study of Tamarkoz® and Stress management resources in Stress, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Loma Linda University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Non-randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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®.

Read the 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.

02

Conditions studied

  • Stress

Keywords

  • Stress
  • Relaxation
  • Health promotion
03

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
103 participants (actual)

Study arms

  • 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®

  • 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

  • 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.

Interventions

  • BehavioralTamarkoz®

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

  • BehavioralStress 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change between baseline and 18 weeks

Secondary outcomes

  1. 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.

    Time frame: Change between baseline and 18 weeks

06

Study locations

1 site
  • University of California, Berkeley
    Berkeley, California 94720, United States
07

References and documents

Publications

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Individual participant data

Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03489148
Lead sponsor
Loma Linda University
Responsible party
Sponsor
First posted
Apr 5, 2018
Start date
Aug 24, 2015
Primary completion
Feb 4, 2016
Completion
Feb 4, 2016
Last update
Apr 5, 2018

Study contacts

Nasim Bahadorani, DrPH
principal investigator · Loma Linda University
Jerry W Lee, PhD
study chair · Loma Linda University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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