Lowering Stress Levels of Women in Lebanon

Stress Clinical Trial

— TML  

Official title:

Effects of Transcendental Meditation on Rural Women of Lebanon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836129
• Other study ID #: 30-62050-3816
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

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

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Related Conditions & MeSH terms

• Happiness
• Resilience
• Self Efficacy
• Stress

Intervention

Behavioral:
• Transcendental Meditation (TM) practice
See previous description

Other:
• Stress reduction class (online)
See previous description

Locations

Country	Name	City	State
Lebanon	TM Home of Pure Knowledge Center	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi International University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 1 and 3-months on the Perceived Stress Scale(PSS-10)	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)
Primary	Change from baseline to 1 and 3-months on the Connor-Davidson Resilience Scale (CDRS-10)	The CDRS-10 measures how well one is equipped to bounce back after stressful events, tragedy, or trauma	Change = (week 12-baseline)
Primary	Change from baseline to 1 and 3-months on the Arabic Scale of Happiness (ASH-20)	The ASH-20 seeks to conduct a global, subjective assessment of whether a person is happy or unhappy	Change = (week 12-baseline)
Primary	Change from baseline to 1 and 3-months on the New General Self-Efficacy Scale (NGSE-8)	The New General Self-Efficacy Scale assesses how much people believe they can achieve their goals, despite difficulties.	Change = (week 12-baseline)