Lowering Stress Levels of Women in Lebanon (TML)

March 11, 2024 updated by: Marie Loiselle, Maharishi International University

Effects of Transcendental Meditation on Rural Women of Lebanon

The goal of this clinical trial is to compare the experiences of women who learn the TM technique to those who do not. The main questions it aims to answer are:

  1. Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not.
  2. Do women in rural Lebanon who practice the TM technique experience increased happiness, self-efficacy, and resilience levels compared to those who do not.

Participants will:

  • complete baseline surveys
  • be divided into experimental and active-control groups
  • those in the experimental group will learn the TM technique, the control group will be offered an online didactic course on stress reduction

  • both groups will complete post-test surveys at the end of 1 and 3 months

    • Researchers will compare experimental and control groups to see if the intervention effects stress levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methods: We will measure the effects of TM on 62+ women of the Chouf region of Lebanon using the following measures: Perceived Stress Scale, Connor-Davidson Resiliency Scale, New General Self-Efficacy Scale, and the Arabic Scale of Happiness. This is a randomized controlled trial with an experimental group and an active wait-list control group.

Measurements will be taken at baseline (pre-test) and at 1 and 3 months post-test.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • 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

  • Lebanon
      • Beirut, Lebanon, 0000
        • TM Home of Pure Knowledge Center

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Females living in the Chouf region of Lebanon between the ages of 18-95.

-

Exclusion Criteria: Anyone: not female, under 18 or over 95, not in sound mental condition.

-

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TM Group
The intervention used for this group is instruction in the Transcendental Meditation practice. It is a four day course of instruction with 1.5 hours of instruction over four consecutive days, followed by an additional 1.5 hours of instruction ten days later.
Behavioral: Transcendental Meditation (TM) practice
See previous description
Active Comparator: Active Control Group
This group will be offered an online stress reduction course consisting of two 20-60 minute classes for the first month of the trial.
Other: Stress reduction class (online)
See previous description

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)
Time Frame: Change = (week 12-baseline)
The PSS measures the degree to which situations in one's life are appraised as stressful. Possible scores range from 0=never to 4=very often
Change = (week 12-baseline)
Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)
Time Frame: Change = (week 12-baseline)
The CDRS-10 measures how well one is equipped to bounce back after stressful events, tragedy, or trauma
Change = (week 12-baseline)
Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20)
Time Frame: Change = (week 12-baseline)
The ASH-20 seeks to conduct a global, subjective assessment of whether a person is happy or unhappy
Change = (week 12-baseline)
Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8)
Time Frame: Change = (week 12-baseline)
The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties.
Change = (week 12-baseline)

Collaborators and Investigators

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

Sponsor

Maharishi International University

Investigators

  • Study Director: Ghada Fakhreddine, BA, Chouf Development Council and the Ladies Foundation for Pure Knowledge

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)

May 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 30-62050-3816

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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