Lowering Stress Levels of Women in Lebanon

NCT ID: NCT05836129

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Resilience Self Efficacy Happiness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
The statistician will not be aware of which arm the participants are in.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Transcendental Meditation (TM) practice

Intervention Type BEHAVIORAL

See previous description

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.

Group Type ACTIVE_COMPARATOR

Stress reduction class (online)

Intervention Type OTHER

See previous description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcendental Meditation (TM) practice

See previous description

Intervention Type BEHAVIORAL

Stress reduction class (online)

See previous description

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maharishi International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marie Loiselle

Director of Evaluation, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ghada Fakhreddine, BA

Role: STUDY_DIRECTOR

Chouf Development Council and the Ladies Foundation for Pure Knowledge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

TM Home of Pure Knowledge Center

Beirut, , Lebanon

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

30-62050-3816

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.